Combination Chemotx in Treating Children or Adolescents With Newly Diagnosed Stg III or Stg IV Lymphoblastic Lymphoma
Sponsor
Children's Oncology Group (Other)
Overall Status
Completed
CT.gov ID
NCT00004228
Collaborator
National Cancer Institute (NCI) (NIH)
393
176
7
177.9
2.2
0
Study Details
Study Description
Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. It is not yet known which regimen of combination chemotherapy is most effective for lymphoblastic lymphoma.
PURPOSE: This randomized phase III trial is studying different regimens of combination chemotherapy to compare how well they work in treating children or adolescents with newly diagnosed stage III or stage IV lymphoblastic lymphoma.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
OBJECTIVES:
-
Compare the event-free survival and overall survival of children or adolescents with newly diagnosed disseminated stage III or IV lymphoblastic lymphoma treated with 4 chemotherapy regimens*.
-
Determine whether treatment with a regimen without methotrexate maintains the same disease-free survival as NHL/BFM 90 in these patients.
-
Determine whether intensification with anthracycline and cyclophosphamide improves disease-free survival in these patients.
-
Collect outcome data on uniformly treated patients with localized disease or CNS-positive disease.
-
Determine whether rapid reduction in tumor volume by chest radiography and CT scan is predictive of improved outcome in patients treated with these regimens.
-
Determine the prevalence of bone marrow involvement at presentation in these patients.
-
Determine whether peripheral blood can replace bone marrow in the initial staging of these patients.
-
Determine the clinical significance of bone marrow and peripheral blood involvement in these patients.
NOTE: *All patients as of 4/2006 receive treatment on Arm III regimen only
OUTLINE: Patients are stratified by disease characteristics (disseminated lymphoblastic lymphoma vs localized lymphoblastic lymphoma [localized lymphoblastic lymphoma is closed to accrual as of 10/2005]) and age. Patients with CNS negative disseminated lymphoblastic lymphoma are randomized to 1 of 4 treatment arms*. Patients with testicular involvement at diagnosis are nonrandomly assigned to arm IV and do not receive testicular radiotherapy. Patients with localized lymphoblastic lymphoma (closed to accrual as of 10/2005) are not randomized.
NOTE: *All patients as of 4/2006 receive treatment on Arm III only
-
Localized lymphoblastic lymphoma (closed to accrual as of 10/2005):
-
Induction (5 weeks): Patients receive vincristine IV and daunorubicin IV over 15 minutes to 2 hours on days 0, 7, 14, and 21; oral prednisone on days 0-27; and asparaginase intramuscularly (IM) on days 3, 5, and 7 and then 3 times a week for 9 doses (during days 8-21). Patients also receive methotrexate intrathecally (IT) on days 7 and 28 and cytarabine IT on day 0.
-
Consolidation (5 weeks): Patients receive methotrexate IT on days 0, 7, 14, and 21 followed by cyclophosphamide IV over 1 hour on days 0 and 14; cytarabine IV on days 0-3, 7-10, 14-17, and 21-24; oral mercaptopurine on days 0-27; and oral prednisone over 10 days.
-
Interim maintenance (8 weeks): Patients receive methotrexate IT on days 0 and 28; oral mercaptopurine on days 0-41; and oral methotrexate on days 7, 14, 21, and 35.
-
Delayed intensification (7 weeks): Patients receive vincristine IV and doxorubicin IV over 15 minutes to 2 hours on days 0, 7, and 14; asparaginase IM on day 3 and then 3 times a week for 6 doses; oral dexamethasone on days 0-30; cyclophosphamide IV over 1 hour on day 28; and cytarabine IV or SC on days 28-31 and 35-38. Patients also receive oral thioguanine on days 28-41 and methotrexate IT on days 28 and 35.
-
Maintenance (84 day course): Patients receive vincristine IV on days 0, 28, and 56; oral prednisone on days 0-4, 28-32, and 56-60; oral methotrexate on days 7, 14, 21, 28, 35, 42, 49, 56, 63, 70, and 77; oral mercaptopurine on days 0-83; and methotrexate IT on day 0.
-
Disseminated lymphoblastic lymphoma:
-
Arm I (closed to accrual as of 4/2006): Patients receive same induction, consolidation, and interim maintenance therapy schedule as localized lymphoblastic lymphoma patients.
-
Delayed intensification (7 weeks): Patients receive vincristine IV and doxorubicin IV over 15 minutes to 2 hours on days 0, 7, 14, and 21; asparaginase IM on day 3 and then 3 times a week for 6 doses; and oral dexamethasone on days 0-28. Patients also receive cyclophosphamide IV over 1 hour on day 35; cytarabine IV or SC on days 35-38 and 42-45; oral thioguanine on days 35-48; and methotrexate IT on days 35 and 42.
-
Maintenance (84 day course): Patients receive same therapy as localized lymphoblastic lymphoma patients, except methotrexate IT is administered on day 0 and 28 (for first 4 courses).
-
Arm II (closed to accrual as of 4/2006): Patients receive consolidation, interim maintenance, and maintenance therapy as in arm I.
-
Induction (5 weeks): Patients receive vincristine IV on days 0, 7, 14, and 21; daunorubicin IV over 48 hours on days 0-2; oral prednisone on days 0-27; and asparaginase IM on days 3, 5, and 7 and then 3 times a week for 9 doses (during days 8-21). Patients also receive methotrexate IT on days 7 and 28; cyclophosphamide IV over 1 hour on day 2; and cytarabine IT on day 0.
-
Delayed intensification (7 weeks): Patients receive vincristine IV on days 0, 7, 14, 21; daunorubicin IV over 48 hours on days 0-2; asparaginase IM on day 3 and then 3 times a week for 6 doses; and oral dexamethasone on days 0-28. Patients also receive cyclophosphamide IV over 1 hour on days 2 and 35; cytarabine IV or SC on days 35-38 and 42-45; oral thioguanine on days 35-48; and methotrexate IT on days 35 and 42.
-
Arm III:
-
Induction (5 weeks): Patients receive vincristine IV and daunorubicin IV over 1 hour on days 0, 7, 14, and 21 and oral prednisone on days 0-37. Patients also receive asparaginase IM on day 11 and then 3 times a week for 9 doses; methotrexate IT on days 7 and 28; and cytarabine IT on day 0.
-
Consolidation (5 weeks): Patients receive methotrexate IT and cyclophosphamide IV over 1 hour on days 0 and 14; cytarabine IV or SC on days 0-3, 7-10, 14-17, and 21-24; oral mercaptopurine on days 0-27; and oral prednisone over 10 days.
-
Interim maintenance (9 weeks): Patients receive methotrexate IT and IV on days 7, 21, 35, and 49; oral mercaptopurine on days 0-55; and leucovorin calcium IV at 42, 48, and 54 hours after methotrexate IV.
-
Delayed intensification (10 weeks): Patients receive vincristine IV and doxorubicin IV over 1 hour on days 0, 7, 14, and 21; asparaginase IM on day 3 and then 3 times a week for 6 doses; and oral dexamethasone on days 0-29. Patients also receive cyclophosphamide IV over 1 hour on day 35; cytarabine IV on days 35-38 and 42-45; oral thioguanine on days 35-48; and methotrexate IT on days 35 and 42.
-
Maintenance (84 day courses): Patients receive vincristine IV on days 0, 28, and 56; oral prednisone on days 0-4, 28-32, and 56-60; oral methotrexate on days 7, 14, 21, 28, 35, 42, 49, 56, 63, 70, and 77; and oral mercaptopurine on days 0-83.
-
Arm IV (closed to accrual as of 4/2006): Patients receive consolidation and interim maintenance therapy as in arm III.
-
Induction: Patients receive vincristine IV on days 0, 7, 14, and 21; daunorubicin IV over 48 hours on days 0-2; oral prednisone on days 0-37; asparaginase IM on day 11 and then 3 times a week for 9 doses; methotrexate IT on days 7, 14, 21, and 28; cyclophosphamide IV on day 2; and cytarabine IT on day 0.
-
Delayed intensification (10 weeks): Patients receive vincristine IV on days 7, 14, 21, and 28; daunorubicin IV over 48 hours on days 0-2; asparaginase IM on day 3 and then 3 times a week for 6 doses; and oral dexamethasone on days 0-29. Patients also receive cyclophosphamide IV over 1 hour on days 2 and 35; cytarabine IV on days 35-38 and 42-45; oral thioguanine on days 35-48; and methotrexate IT on days 35 and 42.
-
Maintenance (84 day courses): Patients receive therapy as in arm III. Patients who are over 1 year of age and have CNS disease at diagnosis undergo cranial radiotherapy once daily 5 days a week beginning on day 0. Patients over 2 years of age undergo radiotherapy over 11-14 days (6-9 days for 1-2 years of age).
Patients are followed monthly for one year, every 3 months for 1 year, every 6 months for 1.5 years, and then annually thereafter.
PROJECTED ACCRUAL: Approximately 250-400 patients will be accrued for this study within 5 years.
Study Design
Study Type:
Interventional
Actual Enrollment
:
393 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Randomized Phase III Study for the Treatment of Newly Diagnosed Disseminated Lymphoblastic Lymphoma or Localized Lymphoblastic Lymphoma
Study Start Date
:
Jun 1, 2000
Actual Primary Completion Date
:
Aug 1, 2008
Actual Study Completion Date
:
Mar 31, 2015
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: A0 (localized disease Stg I/II) Modified CCG BFM Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Doxorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Methotrexate, Intrathecal Methotrexate) |
Drug: asparaginase
Given IV
Other Names:
Drug: cyclophosphamide
Given IV
Other Names:
Drug: cytarabine
Given IV
Other Names:
Drug: daunorubicin hydrochloride
Given IV
Other Names:
Drug: dexamethasone
Given IV
Other Names:
Drug: doxorubicin hydrochloride
Given IV
Other Names:
Drug: mercaptopurine
Given IV
Other Names:
Drug: methotrexate
Given IV
Other Names:
Drug: prednisone
Given IV
Other Names:
Drug: thioguanine
Given PO
Other Names:
Drug: vincristine sulfate
Given IV
Other Names:
|
| Experimental: A1 (Disseminated, No CNS - CCG mod BFM w/out intens Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, doxorubicin hydrochloride, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, prednisone, Methotrexate, Intrathecal Methotrexate) |
Drug: asparaginase
Given IV
Other Names:
Drug: cyclophosphamide
Given IV
Other Names:
Drug: cytarabine
Given IV
Other Names:
Drug: daunorubicin hydrochloride
Given IV
Other Names:
Drug: dexamethasone
Given IV
Other Names:
Drug: doxorubicin hydrochloride
Given IV
Other Names:
Drug: mercaptopurine
Given IV
Other Names:
Drug: methotrexate
Given IV
Other Names:
Drug: prednisone
Given IV
Other Names:
Drug: thioguanine
Given PO
Other Names:
Drug: vincristine sulfate
Given IV
Other Names:
|
| Experimental: A2 (Disseminated, No CNS - CCG mod BFM w/ intens Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate) |
Drug: asparaginase
Given IV
Other Names:
Drug: cyclophosphamide
Given IV
Other Names:
Drug: cytarabine
Given IV
Other Names:
Drug: daunorubicin hydrochloride
Given IV
Other Names:
Drug: dexamethasone
Given IV
Other Names:
Drug: doxorubicin hydrochloride
Given IV
Other Names:
Drug: mercaptopurine
Given IV
Other Names:
Drug: methotrexate
Given IV
Other Names:
Drug: prednisone
Given IV
Other Names:
Drug: thioguanine
Given PO
Other Names:
Drug: vincristine sulfate
Given IV
Other Names:
|
| Experimental: B2 (CNS+) NHL/BFM-95 w/intens delayed radiation therapy Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate) |
Drug: asparaginase
Given IV
Other Names:
Drug: cyclophosphamide
Given IV
Other Names:
Drug: cytarabine
Given IV
Other Names:
Drug: daunorubicin hydrochloride
Given IV
Other Names:
Drug: dexamethasone
Given IV
Other Names:
Drug: doxorubicin hydrochloride
Given IV
Other Names:
Drug: leucovorin calcium
Given IV
Other Names:
Drug: mercaptopurine
Given IV
Other Names:
Drug: methotrexate
Given IV
Other Names:
Drug: prednisone
Given IV
Other Names:
Drug: thioguanine
Given PO
Other Names:
Drug: vincristine sulfate
Given IV
Other Names:
Radiation: radiation therapy
|
| Experimental: B1 (Disseminated CNS- <Amend 7B) NHL/BFM-95 w/out intens Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, doxorubicin hydrochloride, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate) |
Drug: asparaginase
Given IV
Other Names:
Drug: cyclophosphamide
Given IV
Other Names:
Drug: cytarabine
Given IV
Other Names:
Drug: daunorubicin hydrochloride
Given IV
Other Names:
Drug: dexamethasone
Given IV
Other Names:
Drug: doxorubicin hydrochloride
Given IV
Other Names:
Drug: leucovorin calcium
Given IV
Other Names:
Drug: mercaptopurine
Given IV
Other Names:
Drug: methotrexate
Given IV
Other Names:
Drug: prednisone
Given IV
Other Names:
Drug: thioguanine
Given PO
Other Names:
Drug: vincristine sulfate
Given IV
Other Names:
|
| Experimental: B2 (Disseminated,CNS- (< Amend 7B)) NHL/BFM-95 w/intens Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate) |
Drug: asparaginase
Given IV
Other Names:
Drug: cyclophosphamide
Given IV
Other Names:
Drug: cytarabine
Given IV
Other Names:
Drug: daunorubicin hydrochloride
Given IV
Other Names:
Drug: dexamethasone
Given IV
Other Names:
Drug: doxorubicin hydrochloride
Given IV
Other Names:
Drug: leucovorin calcium
Given IV
Other Names:
Drug: mercaptopurine
Given IV
Other Names:
Drug: methotrexate
Given IV
Other Names:
Drug: prednisone
Given IV
Other Names:
Drug: thioguanine
Given PO
Other Names:
Drug: vincristine sulfate
Given IV
Other Names:
|
| Experimental: B1 (Disseminated CNS-) NHL/BFM-95 w/out intens Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, doxorubicin hydrochloride, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate) |
Drug: asparaginase
Given IV
Other Names:
Drug: cyclophosphamide
Given IV
Other Names:
Drug: cytarabine
Given IV
Other Names:
Drug: daunorubicin hydrochloride
Given IV
Other Names:
Drug: dexamethasone
Given IV
Other Names:
Drug: doxorubicin hydrochloride
Given IV
Other Names:
Drug: leucovorin calcium
Given IV
Other Names:
Drug: mercaptopurine
Given IV
Other Names:
Drug: methotrexate
Given IV
Other Names:
Drug: prednisone
Given IV
Other Names:
Drug: thioguanine
Given PO
Other Names:
Drug: vincristine sulfate
Given IV
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Event-free Survival [5 years]
Assessed by time to treatment failure, occurrence of second malignant neoplasm, or death from any cause. Statistical analysis will be to estimate the difference in the proportion of patients treated with each therapy who are long-term event-free survivors due either to the difference between the backbone therapy regimens (CCG BFM vs NHL/BFM-95), or due to the intensification.
Secondary Outcome Measures
- Percentage of Patients With Overall Survival as Assessed by Time to Death [5 years]
Overall survival will be computed by measuring the rate of deaths during induction due primarily to treatment toxicity and cumulative incidence of toxic deaths in induction or deaths in remission overall and separately for treatment groups defined by the two design factors.
Eligibility Criteria
Criteria
Ages Eligible for Study:
1 Year
to 30 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
DISEASE CHARACTERISTICS:
-
Newly diagnosed disseminated lymphoblastic lymphoma or localized lymphoblastic lymphoma*
-
Less than 25% tumor cells in the bone marrow
-
Previously untreated (prior intrathecal cytarabine allowed if protocol therapy begins within 72 hours)
-
Stage III or IV disease
-
NOTE: *Localized lymphoblastic lymphoma is closed to accrual as of 10/2005
PATIENT CHARACTERISTICS:
Age:
- 1 to 30
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Not specified
Renal:
- Not specified
Cardiovascular:
- Adequate cardiac function
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- See Disease Characteristics
Endocrine therapy:
- Emergency steroid therapy (if required) must be started within 72 hours prior to protocol therapy
Radiotherapy:
- Emergency radiotherapy (if required) must be started within 72 hours prior to protocol therapy
Surgery:
- Not specified
Other:
- No other prior therapy except for emergency treatment of airway obstruction and/or superior vena cava syndrome
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham | Birmingham | Alabama | United States | 35294 |
| 2 | Phoenix Children's Hospital | Phoenix | Arizona | United States | 85016-7710 |
| 3 | Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | Little Rock | Arkansas | United States | 72205 |
| 4 | Southern California Permanente Medical Group | Downey | California | United States | 90242-2814 |
| 5 | City of Hope Comprehensive Cancer Center | Duarte | California | United States | 91010-3000 |
| 6 | Loma Linda University Cancer Institute at Loma Linda University Medical Center | Loma Linda | California | United States | 92354 |
| 7 | Jonathan Jaques Children's Cancer Center at Miller Children's Hospital | Long Beach | California | United States | 90801 |
| 8 | Childrens Hospital Los Angeles | Los Angeles | California | United States | 90027 |
| 9 | Jonsson Comprehensive Cancer Center at UCLA | Los Angeles | California | United States | 90095-1781 |
| 10 | Children's Hospital Central California | Madera | California | United States | 93638-8762 |
| 11 | Children's Hospital of Orange County | Orange | California | United States | 92868 |
| 12 | Sutter Cancer Center | Sacramento | California | United States | 95816 |
| 13 | University of California Davis Cancer Center | Sacramento | California | United States | 95817 |
| 14 | Kaiser Permanente Medical Center - Oakland | Sacramento | California | United States | 95825 |
| 15 | Children's Hospital and Health Center - San Diego | San Diego | California | United States | 92123-4282 |
| 16 | UCSF Comprehensive Cancer Center | San Francisco | California | United States | 94115 |
| 17 | Stanford Comprehensive Cancer Center - Stanford | Stanford | California | United States | 94305 |
| 18 | Children's Hospital Cancer Center | Denver | Colorado | United States | 80218-1088 |
| 19 | Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center | Farmington | Connecticut | United States | 06360-2875 |
| 20 | Children's National Medical Center | Washington | District of Columbia | United States | 20010-2970 |
| 21 | Broward General Medical Center Cancer Center | Fort Lauderdale | Florida | United States | 33316 |
| 22 | Lee Cancer Care of Lee Memorial Health System | Fort Myers | Florida | United States | 33901 |
| 23 | University of Florida Shands Cancer Center | Gainesville | Florida | United States | 32610-0232 |
| 24 | Memorial Cancer Institute at Memorial Regional Hospital | Hollywood | Florida | United States | 33021 |
| 25 | Nemours Children's Clinic | Jacksonville | Florida | United States | 32207 |
| 26 | University of Miami Sylvester Comprehensive Cancer Center - Miami | Miami | Florida | United States | 33136 |
| 27 | Miami Children's Hospital | Miami | Florida | United States | 33155 |
| 28 | Florida Hospital Cancer Institute at Florida Hospital Orlando | Orlando | Florida | United States | 32803-1273 |
| 29 | M.D. Anderson Cancer Center at Orlando | Orlando | Florida | United States | 32806 |
| 30 | Nemours Children's Clinic - Orlando | Orlando | Florida | United States | 32806 |
| 31 | Sacred Heart Cancer Center at Sacred Heart Hospital | Pensacola | Florida | United States | 32504 |
| 32 | All Children's Hospital | Saint Petersburg | Florida | United States | 33701 |
| 33 | St. Joseph's Cancer Institute at St. Joseph's Hospital | Tampa | Florida | United States | 33607 |
| 34 | Kaplan Cancer Center at St. Mary's Medical Center | West Palm Beach | Florida | United States | 33407 |
| 35 | Winship Cancer Institute of Emory University | Atlanta | Georgia | United States | 30322 |
| 36 | MBCCOP - Medical College of Georgia Cancer Center | Augusta | Georgia | United States | 30912-3730 |
| 37 | Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center | Savannah | Georgia | United States | 31403-3089 |
| 38 | St. Luke's Mountain States Tumor Institute - Boise | Boise | Idaho | United States | 83712-6297 |
| 39 | University of Illinois Cancer Center | Chicago | Illinois | United States | 60612-7243 |
| 40 | Children's Memorial Hospital - Chicago | Chicago | Illinois | United States | 60614 |
| 41 | Cardinal Bernardin Cancer Center at Loyola University Medical Center | Maywood | Illinois | United States | 60153 |
| 42 | Indiana University Melvin and Bren Simon Cancer Center | Indianapolis | Indiana | United States | 46202-5289 |
| 43 | Blank Children's Hospital | Des Moines | Iowa | United States | 50309 |
| 44 | Holden Comprehensive Cancer Center at University of Iowa | Iowa City | Iowa | United States | 52242-1002 |
| 45 | Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center | Kansas City | Kansas | United States | 66160-7357 |
| 46 | Markey Cancer Center at University of Kentucky Chandler Medical Center | Lexington | Kentucky | United States | 40536-0293 |
| 47 | Kosair Children's Hospital | Louisville | Kentucky | United States | 40232 |
| 48 | Tulane Cancer Center | Alexandria | Louisiana | United States | 71315-3198 |
| 49 | Children's Hospital of New Orleans | New Orleans | Louisiana | United States | 70118 |
| 50 | Ochsner Cancer Institute at Ochsner Clinic Foundation | New Orleans | Louisiana | United States | 70121 |
| 51 | CancerCare of Maine at Eastern Maine Medial Center | Bangor | Maine | United States | 04401 |
| 52 | Maine Children's Cancer Program at Barbara Bush Children's Hospital | Scarborough | Maine | United States | 04074-9308 |
| 53 | Alvin and Lois Lapidus Cancer Institute at Sinai Hospital | Baltimore | Maryland | United States | 21215 |
| 54 | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore | Maryland | United States | 21231-2410 |
| 55 | Floating Hospital for Children at Tufts - New England Medical Center | Boston | Massachusetts | United States | 02111 |
| 56 | C.S. Mott Children's Hospital at University of Michigan Medical Center | Ann Arbor | Michigan | United States | 48109-0238 |
| 57 | Barbara Ann Karmanos Cancer Institute | Detroit | Michigan | United States | 48201-1379 |
| 58 | Hurley Medical Center | Flint | Michigan | United States | 48503 |
| 59 | Spectrum Health Hospital - Butterworth Campus | Grand Rapids | Michigan | United States | 49503-2560 |
| 60 | Van Elslander Cancer Center at St. John Hospital and Medical Center | Grosse Pointe Woods | Michigan | United States | 48236 |
| 61 | CCOP - Kalamazoo | Kalamazoo | Michigan | United States | 49007-5341 |
| 62 | Breslin Cancer Center at Ingham Regional Medical Center | Lansing | Michigan | United States | 48910 |
| 63 | William Beaumont Hospital - Royal Oak Campus | Royal Oak | Michigan | United States | 48073 |
| 64 | Children's Hospitals and Clinics of Minnesota - Minneapolis | Minneapolis | Minnesota | United States | 55404 |
| 65 | University of Minnesota Children's Hospital - Fairview | Minneapolis | Minnesota | United States | 55455 |
| 66 | Mayo Clinic Cancer Center | Rochester | Minnesota | United States | 55905 |
| 67 | University of Mississippi Cancer Clinic | Jackson | Mississippi | United States | 39216-4505 |
| 68 | Ellis Fischel Cancer Center at University of Missouri - Columbia | Columbia | Missouri | United States | 65203 |
| 69 | Children's Mercy Hospital | Kansas City | Missouri | United States | 64108 |
| 70 | Cardinal Glennon Children's Hospital | Saint Louis | Missouri | United States | 63104 |
| 71 | Siteman Cancer Center at Barnes-Jewish Hospital | Saint Louis | Missouri | United States | 63110 |
| 72 | Children's Hospital | Omaha | Nebraska | United States | 68114-4113 |
| 73 | UNMC Eppley Cancer Center at the University of Nebraska Medical Center | Omaha | Nebraska | United States | 68198-6805 |
| 74 | Sunrise Hospital and Medical Center | Las Vegas | Nevada | United States | 89109-2306 |
| 75 | Norris Cotton Cancer Center at Dartmouth - Hitchcock Medical Center | Lebanon | New Hampshire | United States | 03756-0002 |
| 76 | Hackensack University Medical Center Cancer Center | Hackensack | New Jersey | United States | 07601 |
| 77 | St. Barnabas Medical Center Cancer Center | Livingston | New Jersey | United States | 07039 |
| 78 | Overlook Hospital | Morristown | New Jersey | United States | 07962 |
| 79 | Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School | New Brunswick | New Jersey | United States | 08903 |
| 80 | Newark Beth Israel Medical Center | Newark | New Jersey | United States | 07112 |
| 81 | St. Joseph's Hospital and Medical Center | Paterson | New Jersey | United States | 07503 |
| 82 | University of New Mexico Cancer Research and Treatment Center | Albuquerque | New Mexico | United States | 87131-5636 |
| 83 | Brooklyn Hospital Center | Brooklyn | New York | United States | 11201-5493 |
| 84 | Roswell Park Cancer Institute | Buffalo | New York | United States | 14263-0001 |
| 85 | Winthrop University Hospital | Mineola | New York | United States | 11501 |
| 86 | Schneider Children's Hospital | New Hyde Park | New York | United States | 11040 |
| 87 | NYU Cancer Institute at New York University Medical Center | New York | New York | United States | 10016 |
| 88 | Mount Sinai Medical Center | New York | New York | United States | 10029 |
| 89 | Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center | New York | New York | United States | 10032 |
| 90 | James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester | New York | United States | 14642 |
| 91 | Stony Brook University Cancer Center | Stony Brook | New York | United States | 11794-8174 |
| 92 | SUNY Upstate Medical University Hospital | Syracuse | New York | United States | 13210 |
| 93 | New York Medical College | Valhalla | New York | United States | 10595 |
| 94 | Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Chapel Hill | North Carolina | United States | 27599-7295 |
| 95 | Blumenthal Cancer Center at Carolinas Medical Center | Charlotte | North Carolina | United States | 28232-2861 |
| 96 | Presbyterian Cancer Center at Presbyterian Hospital | Charlotte | North Carolina | United States | 28233-3549 |
| 97 | Duke Comprehensive Cancer Center | Durham | North Carolina | United States | 27710 |
| 98 | Leo W. Jenkins Cancer Center at ECU Medical School | Greenville | North Carolina | United States | 27835-6028 |
| 99 | Wake Forest University Comprehensive Cancer Center | Winston-Salem | North Carolina | United States | 27157-1096 |
| 100 | CCOP - MeritCare Hospital | Fargo | North Dakota | United States | 58122 |
| 101 | Children's Hospital Medical Center of Akron | Akron | Ohio | United States | 44308-1062 |
| 102 | Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | United States | 45229-3039 |
| 103 | Rainbow Babies and Children's Hospital | Cleveland | Ohio | United States | 44106-5000 |
| 104 | Cleveland Clinic Taussig Cancer Center | Cleveland | Ohio | United States | 44195-5217 |
| 105 | Columbus Children's Hospital | Columbus | Ohio | United States | 43205-2696 |
| 106 | Children's Medical Center - Dayton | Dayton | Ohio | United States | 45404-1815 |
| 107 | Toledo Hospital | Toledo | Ohio | United States | 43606 |
| 108 | Medical University of Ohio Cancer Center | Toledo | Ohio | United States | 43614 |
| 109 | Tod Children's Hospital | Youngstown | Ohio | United States | 44501 |
| 110 | Oklahoma University Cancer Institute | Oklahoma City | Oklahoma | United States | 73104 |
| 111 | Legacy Emanuel Hospital and Health Center & Children's Hospital | Portland | Oregon | United States | 97227 |
| 112 | Oregon Health & Science University Cancer Institute | Portland | Oregon | United States | 97239-3098 |
| 113 | Geisinger Medical Center | Danville | Pennsylvania | United States | 17822-0001 |
| 114 | Penn State Cancer Institute at Milton S. Hershey Medical Center | Hershey | Pennsylvania | United States | 17033-0850 |
| 115 | Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | United States | 19104-9786 |
| 116 | Children's Hospital of Pittsburgh | Pittsburgh | Pennsylvania | United States | 15213 |
| 117 | Rhode Island Hospital Comprehensive Cancer Center | Providence | Rhode Island | United States | 02903 |
| 118 | Hollings Cancer Center at Medical University of South Carolina | Charleston | South Carolina | United States | 29425 |
| 119 | Greenville Hospital System Cancer Center | Greenville | South Carolina | United States | 29605 |
| 120 | Sanford Cancer Center at Sanford USD Medical Center | Sioux Falls | South Dakota | United States | 57117-5039 |
| 121 | T.C. Thompson Children's Hospital | Chattanooga | Tennessee | United States | 37403 |
| 122 | East Tennessee Children's Hospital | Knoxville | Tennessee | United States | 37901 |
| 123 | St. Jude Children's Research Hospital | Memphis | Tennessee | United States | 38105 |
| 124 | Vanderbilt-Ingram Cancer Center | Nashville | Tennessee | United States | 37232-6838 |
| 125 | Texas Tech University Health Sciences Center School of Medicine - Amarillo | Amarillo | Texas | United States | 79106 |
| 126 | Children's Hospital of Austin | Austin | Texas | United States | 78701 |
| 127 | Driscoll Children's Hospital | Corpus Christi | Texas | United States | 78411 |
| 128 | Medical City Dallas Hospital | Dallas | Texas | United States | 75230 |
| 129 | Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas | Dallas | Texas | United States | 75390 |
| 130 | Cook Children's Medical Center - Fort Worth | Fort Worth | Texas | United States | 76104-9958 |
| 131 | Baylor University Medical Center - Houston | Houston | Texas | United States | 77030-2399 |
| 132 | M. D. Anderson Cancer Center at University of Texas | Houston | Texas | United States | 77030-4009 |
| 133 | Covenant Children's Hospital | Lubbock | Texas | United States | 79410 |
| 134 | University of Texas Health Science Center at San Antonio | San Antonio | Texas | United States | 78207 |
| 135 | Methodist Children's Hospital of South Texas | San Antonio | Texas | United States | 78229-3993 |
| 136 | CCOP - Scott and White Hospital | Temple | Texas | United States | 76508 |
| 137 | Primary Children's Medical Center | Salt Lake City | Utah | United States | 84113-1100 |
| 138 | Fletcher Allen Health Care - University Health Center Campus | Burlington | Vermont | United States | 05405 |
| 139 | University of Virginia Cancer Center | Charlottesville | Virginia | United States | 22908 |
| 140 | INOVA Fairfax Hospital | Fairfax | Virginia | United States | 22031 |
| 141 | Children's Hospital of The King's Daughters | Norfolk | Virginia | United States | 23507-1971 |
| 142 | Virginia Commonwealth University Massey Cancer Center | Richmond | Virginia | United States | 23298-0037 |
| 143 | Carilion Cancer Center of Western Virginia | Roanoke | Virginia | United States | 24029 |
| 144 | Children's Hospital and Regional Medical Center - Seattle | Seattle | Washington | United States | 98105 |
| 145 | Providence Cancer Center at Sacred Heart Medical Center | Spokane | Washington | United States | 99220-2555 |
| 146 | Mary Bridge Children's Hospital and Health Center - Tacoma | Tacoma | Washington | United States | 98405 |
| 147 | Madigan Army Medical Center - Tacoma | Tacoma | Washington | United States | 98431 |
| 148 | Edwards Comprehensive Cancer Center at Cabell Huntington Hospital | Huntington | West Virginia | United States | 25701 |
| 149 | Mary Babb Randolph Cancer Center at West Virginia University Hospitals | Morgantown | West Virginia | United States | 26506 |
| 150 | St. Vincent Hospital Regional Cancer Center | Green Bay | Wisconsin | United States | 54307-3508 |
| 151 | University of Wisconsin Paul P. Carbone Comprehensive Cancer Center | Madison | Wisconsin | United States | 53792-6164 |
| 152 | Marshfield Clinic - Marshfield Center | Marshfield | Wisconsin | United States | 54449 |
| 153 | Prince of Wales Private Hospital | Randwick | New South Wales | Australia | 2031 |
| 154 | Royal Children's Hospital | Herston, Brisbane | Queensland | Australia | 4029 |
| 155 | Women's and Children's Hospital | North Adelaide | South Australia | Australia | 5006 |
| 156 | Royal Children's Hospital | Parkville | Victoria | Australia | 3052 |
| 157 | Princess Margaret Hospital for Children | Perth | Western Australia | Australia | 6001 |
| 158 | Alberta Children's Hospital | Calgary | Alberta | Canada | T3B 6A8 |
| 159 | Children's & Women's Hospital of British Columbia | Vancouver | British Columbia | Canada | V6H 3V4 |
| 160 | CancerCare Manitoba | Winnipeg | Manitoba | Canada | R3E 0V9 |
| 161 | Janeway Children's Health and Rehabilitation Centre | St. John's | Newfoundland and Labrador | Canada | A1B 3V6 |
| 162 | IWK Health Centre | Halifax | Nova Scotia | Canada | B3K 6R8 |
| 163 | McMaster Children's Hospital at Hamilton Health Sciences | Hamilton | Ontario | Canada | L8N 3Z5 |
| 164 | Cancer Centre of Southeastern Ontario at Kingston General Hospital | Kingston | Ontario | Canada | K7L 3N6 |
| 165 | Children's Hospital of Western Ontario | London | Ontario | Canada | N6A 4G5 |
| 166 | Children's Hospital of Eastern Ontario | Ottawa | Ontario | Canada | K1H 8L1 |
| 167 | Hospital for Sick Children | Toronto | Ontario | Canada | M5G 1X8 |
| 168 | Montreal Children's Hospital at McGill University Health Center | Montreal | Quebec | Canada | H3H 1P3 |
| 169 | Hopital Sainte Justine | Montreal | Quebec | Canada | H3T 1C5 |
| 170 | Allan Blair Cancer Centre at Pasqua Hospital | Regina | Saskatchewan | Canada | S4T 7T1 |
| 171 | Saskatoon Cancer Centre at the University of Saskatchewan | Saskatoon | Saskatchewan | Canada | S7N 4H4 |
| 172 | Centre Hospitalier Universitaire de Quebec | Quebec | Canada | G1V 4G2 | |
| 173 | San Jorge Children's Hospital | Santurce | Puerto Rico | 00912 | |
| 174 | Swiss Pediatric Oncology Group Bern | Bern | Switzerland | 3010 | |
| 175 | Swiss Pediatric Oncology Group Geneva | Geneva | Switzerland | 1205 | |
| 176 | Swiss Pediatric Oncology Group Lausanne | Lausanne | Switzerland | 1011 |
Sponsors and Collaborators
- Children's Oncology Group
- National Cancer Institute (NCI)
Investigators
- Study Chair: Minnie Abromowitch, MD, Children's Hospital Medical Center, Cincinnati
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT00004228
Other Study ID Numbers:
- A5971
- CCG-59701
- CCG-59701C
- CCG-A5971
- POG-A5971
- CDR0000067470
First Posted:
Jan 27, 2003
Last Update Posted:
Aug 6, 2019
Last Verified:
Nov 1, 2016
Keywords provided by Children's Oncology Group
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | A0 (Localized Disease Stg I/II) Modified CCG BFM | A1 (Disseminated, No CNS - CCG Mod BFM w/Out Intens | A2 (Disseminated, No CNS - CCG Mod BFM w/ Intens | B2 (CNS+) NHL/BFM-95 w/Intens Delayed Radiation Therapy | B2 (Disseminated,CNS- (< Amend 7B)) NHL/BFM-95 w/Intens | B1 (Disseminated CNS-) NHL/BFM-95 w/Out Intens | B1 (NHL/BFM-95 w/Out Intens) Additional Enrollment |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Doxorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Methotrexate, Intrathecal Methotrexate) | Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, doxorubicin hydrochloride, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, prednisone, Methotrexate, Intrathecal Methotrexate) | Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate) | Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate) | Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate) | Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, doxorubicin hydrochloride, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate) | Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, doxorubicin hydrochloride, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate) |
| Period Title: Overall Study | |||||||
| STARTED | 60 | 66 | 65 | 13 | 67 | 65 | 57 |
| COMPLETED | 51 | 51 | 46 | 6 | 51 | 51 | 45 |
| NOT COMPLETED | 9 | 15 | 19 | 7 | 16 | 14 | 12 |
Baseline Characteristics
| Arm/Group Title | A0 (Localized Disease Stg I/II) Modified CCG BFM | A1 (Disseminated, No CNS - CCG Mod BFM w/Out Intens | A2 (Disseminated, No CNS - CCG Mod BFM w/Intens | B2 (CNS+) NHL/BFM-95 w/Intens Delayed Radiation Therapy | B2 (Disseminated,CNS- (< Amend 7B)) NHL/BFM-95 w/Intens | B1 (Disseminated CNS-) NHL/BFM-95 w/Out Intens | B1 (NHL/BFM-95 w/Out Intens) Additional Enrollment | Total |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Doxorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Methotrexate, Intrathecal Methotrexate) | Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, doxorubicin hydrochloride, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, prednisone, Methotrexate, Intrathecal Methotrexate) | Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate) | Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate) | Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate) | Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, doxorubicin hydrochloride, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate) | Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, doxorubicin hydrochloride, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate) | Total of all reporting groups |
| Overall Participants | 60 | 66 | 65 | 13 | 67 | 65 | 57 | 393 |
| Age (Count of Participants) | ||||||||
| <=18 years |
57
95%
|
62
93.9%
|
63
96.9%
|
12
92.3%
|
65
97%
|
62
95.4%
|
52
91.2%
|
373
94.9%
|
| Between 18 and 65 years |
3
5%
|
4
6.1%
|
2
3.1%
|
1
7.7%
|
2
3%
|
3
4.6%
|
5
8.8%
|
20
5.1%
|
| >=65 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Age (years) [Mean (Standard Deviation) ] | ||||||||
| Mean (Standard Deviation) [years] |
8.7
(4.9)
|
10.5
(5.2)
|
10
(4.8)
|
11.4
(5.3)
|
10.2
(5.1)
|
10.6
(5.1)
|
11.5
(5.1)
|
10.3
(5.1)
|
| Sex: Female, Male (Count of Participants) | ||||||||
| Female |
23
38.3%
|
19
28.8%
|
9
13.8%
|
4
30.8%
|
20
29.9%
|
16
24.6%
|
17
29.8%
|
108
27.5%
|
| Male |
37
61.7%
|
47
71.2%
|
56
86.2%
|
9
69.2%
|
47
70.1%
|
49
75.4%
|
40
70.2%
|
285
72.5%
|
| Ethnicity (NIH/OMB) (Count of Participants) | ||||||||
| Hispanic or Latino |
11
18.3%
|
13
19.7%
|
4
6.2%
|
3
23.1%
|
9
13.4%
|
12
18.5%
|
3
5.3%
|
55
14%
|
| Not Hispanic or Latino |
47
78.3%
|
53
80.3%
|
58
89.2%
|
10
76.9%
|
58
86.6%
|
47
72.3%
|
52
91.2%
|
325
82.7%
|
| Unknown or Not Reported |
2
3.3%
|
0
0%
|
3
4.6%
|
0
0%
|
0
0%
|
6
9.2%
|
2
3.5%
|
13
3.3%
|
| Race (NIH/OMB) (Count of Participants) | ||||||||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
1
1.5%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
0.3%
|
| Asian |
1
1.7%
|
1
1.5%
|
3
4.6%
|
0
0%
|
3
4.5%
|
0
0%
|
1
1.8%
|
9
2.3%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
2
3%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
2
0.5%
|
| Black or African American |
3
5%
|
5
7.6%
|
9
13.8%
|
2
15.4%
|
6
9%
|
5
7.7%
|
11
19.3%
|
41
10.4%
|
| White |
53
88.3%
|
56
84.8%
|
48
73.8%
|
10
76.9%
|
54
80.6%
|
53
81.5%
|
41
71.9%
|
315
80.2%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
02
3.5%
|
2
0.5%
|
| Unknown or Not Reported |
3
5%
|
2
3%
|
4
6.2%
|
1
7.7%
|
4
6%
|
7
10.8%
|
2
3.5%
|
23
5.9%
|
| Region of Enrollment (participants) [Number] | ||||||||
| United States |
48
80%
|
58
87.9%
|
57
87.7%
|
12
92.3%
|
62
92.5%
|
58
89.2%
|
51
89.5%
|
346
88%
|
| Canada |
5
8.3%
|
3
4.5%
|
6
9.2%
|
1
7.7%
|
4
6%
|
4
6.2%
|
4
7%
|
27
6.9%
|
| Australia |
7
11.7%
|
4
6.1%
|
1
1.5%
|
0
0%
|
0
0%
|
3
4.6%
|
1
1.8%
|
16
4.1%
|
| Switzerland |
0
0%
|
1
1.5%
|
1
1.5%
|
0
0%
|
1
1.5%
|
0
0%
|
1
1.8%
|
4
1%
|
Outcome Measures
| Title | Event-free Survival |
|---|---|
| Description | Assessed by time to treatment failure, occurrence of second malignant neoplasm, or death from any cause. Statistical analysis will be to estimate the difference in the proportion of patients treated with each therapy who are long-term event-free survivors due either to the difference between the backbone therapy regimens (CCG BFM vs NHL/BFM-95), or due to the intensification. |
| Time Frame | 5 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| There were 19 total ineligible patients, 4 for A0, 2 for A1, 4 for A2, 1 for B2 (CNS+), 1 for B2 (Disseminated), 2 for B1 (CNS-), and 5 for B1 (NHL additional enrollment) not included in outcome measure analysis. |
| Arm/Group Title | A0 (Localized Disease Stg I/II) Modified CCG BFM | A1 (Disseminated, No CNS - CCG Mod BFM w/Out Intens | A2 (Disseminated, No CNS - CCG Mod BFM w/ Intens | B2 (CNS+) NHL/BFM-95 w/Intens Delayed Radiation Therapy | B2 (Disseminated,CNS- (< Amend 7B)) NHL/BFM-95 w/Intens | B1 (Disseminated CNS-) NHL/BFM-95 w/Out Intens | B1 (NHL/BFM-95 w/Out Intens) Additional Enrollment |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Doxorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Methotrexate, Intrathecal Methotrexate) | Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, doxorubicin hydrochloride, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, prednisone, Methotrexate, Intrathecal Methotrexate) | Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate) | Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate) | Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate) | Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, doxorubicin hydrochloride, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate) | Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, doxorubicin hydrochloride, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate) |
| Measure Participants | 56 | 64 | 61 | 12 | 66 | 63 | 52 |
| Number (95% Confidence Interval) [percentage of particpants] |
88
|
82
|
80
|
63
|
82
|
84
|
90
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | A1 (Disseminated, No CNS - CCG Mod BFM w/Out Intens, A2 (Disseminated, No CNS - CCG Mod BFM w/ Intens, B2 (CNS+) NHL/BFM-95 w/Intens Delayed Radiation Therapy, B1 (Disseminated CNS-) NHL/BFM-95 w/Out Intens, B1 (NHL/BFM-95 w/Out Intens) Additional Enrollment |
|---|---|---|
| Comments | A Cox model was used to assess evidence of a difference in event-free survival comparing regimens A1+A2 ("A: CCG BFM") to regimens B1+B2 ("B: NHL/BFM-95") while adjusting for the other intervention through stratification. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | .97 |
| Comments | ||
| Method | Regression, Cox | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | A1 (Disseminated, No CNS - CCG Mod BFM w/Out Intens, A2 (Disseminated, No CNS - CCG Mod BFM w/ Intens, B2 (CNS+) NHL/BFM-95 w/Intens Delayed Radiation Therapy, B1 (Disseminated CNS-) NHL/BFM-95 w/Out Intens |
|---|---|---|
| Comments | A Cox model was used to assess evidence of a difference in event-free survival comparing A1+B1 ("1: no intensification") to A2 +B2 ("2: intensification"), while adjusting for the other intervention through stratification. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | .63 |
| Comments | ||
| Method | Regression, Cox | |
| Comments | ||
| Title | Percentage of Patients With Overall Survival as Assessed by Time to Death |
|---|---|
| Description | Overall survival will be computed by measuring the rate of deaths during induction due primarily to treatment toxicity and cumulative incidence of toxic deaths in induction or deaths in remission overall and separately for treatment groups defined by the two design factors. |
| Time Frame | 5 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| There were 19 total ineligible patients, 4 for A0, 2 for A1, 4 for A2, 1 for B2 (CNS+), 1 for B2 (Disseminated), 2 for B1 (CNS-), and 5 for B1 (NHL additional enrollment) not included in outcome measure analysis. |
| Arm/Group Title | A0 (Localized Disease Stg I/II) Modified CCG BFM | A1 (Disseminated, No CNS - CCG Mod BFM w/Out Intens | A2 (Disseminated, No CNS - CCG Mod BFM w/Intens | B2 (CNS+) NHL/BFM-95 w/Intens Delayed Radiation Therapy | B2 (Disseminated,CNS- (< Amend 7B)) NHL/BFM-95 w/Intens | B1 (Disseminated CNS-) NHL/BFM-95 w/Out Intens | B1 (NHL/BFM-95 w/Out Intens) Additional Enrollment |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Doxorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Methotrexate, Intrathecal Methotrexate) | Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, doxorubicin hydrochloride, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, prednisone, Methotrexate, Intrathecal Methotrexate) | Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate) | Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate) | Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate) | Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, doxorubicin hydrochloride, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate) | Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, doxorubicin hydrochloride, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate) |
| Measure Participants | 56 | 64 | 61 | 12 | 66 | 63 | 52 |
| Number (95% Confidence Interval) [percentage of participants] |
96
160%
|
84
127.3%
|
88
135.4%
|
81
623.1%
|
85
126.9%
|
85
130.8%
|
92
161.4%
|
Adverse Events
| Time Frame | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | There were 19 total ineligible patients, 4 for A0, 2 for A1, 4 for A2, 1 for B2 (CNS+), 1 for B2 (Disseminated), 2 for B1 (CNS-), and 5 for B1 (NHL additional enrollment). All ineligible patients excluded from adverse event reporting. | |||||||||||||
| Arm/Group Title | A0 (Localized Disease Stg I/II) Modified CCG BFM | A1 (Disseminated, No CNS - CCG Mod BFM w/Out Intens | A2 (Disseminated, No CNS - CCG Mod BFM w/Intens | B2 (CNS+) NHL/BFM-95 w/Intens Delayed Radiation Therapy | B2 (Disseminated,CNS- (< Amend 7B)) NHL/BFM-95 w/Intens | B1 (Disseminated CNS-) NHL/BFM-95 w/Out Intens | B1 (NHL/BFM-95 w/Out Intens) Additional Enrollment | |||||||
| Arm/Group Description | Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Doxorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Methotrexate, Intrathecal Methotrexate) | Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, doxorubicin hydrochloride, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, prednisone, Methotrexate, Intrathecal Methotrexate) | Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate). | Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate) | Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate) | Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate) | Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate) | |||||||
All Cause Mortality |
||||||||||||||
| A0 (Localized Disease Stg I/II) Modified CCG BFM | A1 (Disseminated, No CNS - CCG Mod BFM w/Out Intens | A2 (Disseminated, No CNS - CCG Mod BFM w/Intens | B2 (CNS+) NHL/BFM-95 w/Intens Delayed Radiation Therapy | B2 (Disseminated,CNS- (< Amend 7B)) NHL/BFM-95 w/Intens | B1 (Disseminated CNS-) NHL/BFM-95 w/Out Intens | B1 (NHL/BFM-95 w/Out Intens) Additional Enrollment | ||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | |||||||
Serious Adverse Events |
||||||||||||||
| A0 (Localized Disease Stg I/II) Modified CCG BFM | A1 (Disseminated, No CNS - CCG Mod BFM w/Out Intens | A2 (Disseminated, No CNS - CCG Mod BFM w/Intens | B2 (CNS+) NHL/BFM-95 w/Intens Delayed Radiation Therapy | B2 (Disseminated,CNS- (< Amend 7B)) NHL/BFM-95 w/Intens | B1 (Disseminated CNS-) NHL/BFM-95 w/Out Intens | B1 (NHL/BFM-95 w/Out Intens) Additional Enrollment | ||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 8/56 (14.3%) | 8/64 (12.5%) | 13/61 (21.3%) | 0/12 (0%) | 12/66 (18.2%) | 9/63 (14.3%) | 1/52 (1.9%) | |||||||
| Blood and lymphatic system disorders | ||||||||||||||
| Febrile neutropenia | 1/56 (1.8%) | 1 | 1/64 (1.6%) | 1 | 1/61 (1.6%) | 1 | 0/12 (0%) | 0 | 2/66 (3%) | 2 | 0/63 (0%) | 0 | 0/52 (0%) | 0 |
| Hemoglobin (Hgb) | 2/56 (3.6%) | 2 | 2/64 (3.1%) | 2 | 2/61 (3.3%) | 3 | 0/12 (0%) | 0 | 3/66 (4.5%) | 4 | 4/63 (6.3%) | 5 | 0/52 (0%) | 0 |
| Leukocytes (total WBC) | 8/56 (14.3%) | 8 | 5/64 (7.8%) | 5 | 7/61 (11.5%) | 7 | 0/12 (0%) | 0 | 12/66 (18.2%) | 16 | 7/63 (11.1%) | 10 | 0/52 (0%) | 0 |
| Neutropenia | 0/56 (0%) | 0 | 0/64 (0%) | 0 | 0/61 (0%) | 0 | 0/12 (0%) | 0 | 0/66 (0%) | 0 | 0/63 (0%) | 0 | 1/52 (1.9%) | 1 |
| Cardiac disorders | ||||||||||||||
| Cardiovascular/Arrhythmia | 0/56 (0%) | 0 | 0/64 (0%) | 0 | 0/61 (0%) | 0 | 0/12 (0%) | 0 | 0/66 (0%) | 0 | 1/63 (1.6%) | 1 | 0/52 (0%) | 0 |
| Cardiovascular/General-Other | 0/56 (0%) | 0 | 0/64 (0%) | 0 | 0/61 (0%) | 0 | 0/12 (0%) | 0 | 1/66 (1.5%) | 1 | 0/63 (0%) | 0 | 0/52 (0%) | 0 |
| Eye disorders | ||||||||||||||
| N/V, Diplopia | 0/56 (0%) | 0 | 1/64 (1.6%) | 1 | 0/61 (0%) | 0 | 0/12 (0%) | 0 | 0/66 (0%) | 0 | 0/63 (0%) | 0 | 0/52 (0%) | 0 |
| Gastrointestinal disorders | ||||||||||||||
| Esophagitis | 0/56 (0%) | 0 | 0/64 (0%) | 0 | 1/61 (1.6%) | 1 | 0/12 (0%) | 0 | 0/66 (0%) | 0 | 0/63 (0%) | 0 | 0/52 (0%) | 0 |
| Pancreatitis | 1/56 (1.8%) | 1 | 0/64 (0%) | 0 | 1/61 (1.6%) | 1 | 0/12 (0%) | 0 | 0/66 (0%) | 0 | 1/63 (1.6%) | 1 | 0/52 (0%) | 0 |
| Typhlitis | 0/56 (0%) | 0 | 0/64 (0%) | 0 | 0/61 (0%) | 0 | 0/12 (0%) | 0 | 1/66 (1.5%) | 1 | 0/63 (0%) | 0 | 0/52 (0%) | 0 |
| General disorders | ||||||||||||||
| Fever, Increase BP, Back pain | 0/56 (0%) | 0 | 0/64 (0%) | 0 | 1/61 (1.6%) | 1 | 0/12 (0%) | 0 | 0/66 (0%) | 0 | 0/63 (0%) | 0 | 0/52 (0%) | 0 |
| Headache, Vomiting, Nausea, Pancytopenia, Fever | 0/56 (0%) | 0 | 1/64 (1.6%) | 1 | 0/61 (0%) | 0 | 0/12 (0%) | 0 | 0/66 (0%) | 0 | 0/63 (0%) | 0 | 0/52 (0%) | 0 |
| Hepatobiliary disorders | ||||||||||||||
| Hepatotoxicity | 0/56 (0%) | 0 | 0/64 (0%) | 0 | 0/61 (0%) | 0 | 0/12 (0%) | 0 | 1/66 (1.5%) | 1 | 0/63 (0%) | 0 | 0/52 (0%) | 0 |
| Infections and infestations | ||||||||||||||
| Catheter-related infection | 0/56 (0%) | 0 | 0/64 (0%) | 0 | 1/61 (1.6%) | 1 | 0/12 (0%) | 0 | 0/66 (0%) | 0 | 1/63 (1.6%) | 1 | 0/52 (0%) | 0 |
| infection | 0/56 (0%) | 0 | 0/64 (0%) | 0 | 1/61 (1.6%) | 1 | 0/12 (0%) | 0 | 0/66 (0%) | 0 | 0/63 (0%) | 0 | 0/52 (0%) | 0 |
| Infection (documented clinically or microbiologically) with grade 3 or 4 neutropenia | 2/56 (3.6%) | 2 | 0/64 (0%) | 0 | 3/61 (4.9%) | 3 | 0/12 (0%) | 0 | 0/66 (0%) | 0 | 1/63 (1.6%) | 1 | 0/52 (0%) | 0 |
| Infection without neutropenia | 1/56 (1.8%) | 1 | 1/64 (1.6%) | 1 | 0/61 (0%) | 0 | 0/12 (0%) | 0 | 0/66 (0%) | 0 | 0/63 (0%) | 0 | 0/52 (0%) | 0 |
| Infection/Febrile Neutropenia | 1/56 (1.8%) | 1 | 1/64 (1.6%) | 1 | 0/61 (0%) | 0 | 0/12 (0%) | 0 | 0/66 (0%) | 0 | 0/63 (0%) | 0 | 0/52 (0%) | 0 |
| Infection/Febrile Neutropenia (sepsis) | 0/56 (0%) | 0 | 1/64 (1.6%) | 1 | 0/61 (0%) | 0 | 0/12 (0%) | 0 | 0/66 (0%) | 0 | 0/63 (0%) | 0 | 0/52 (0%) | 0 |
| Investigations | ||||||||||||||
| Bilirubin | 0/56 (0%) | 0 | 0/64 (0%) | 0 | 0/61 (0%) | 0 | 0/12 (0%) | 0 | 0/66 (0%) | 0 | 1/63 (1.6%) | 2 | 1/52 (1.9%) | 1 |
| GGT | 0/56 (0%) | 0 | 0/64 (0%) | 0 | 0/61 (0%) | 0 | 0/12 (0%) | 0 | 0/66 (0%) | 0 | 0/63 (0%) | 0 | 1/52 (1.9%) | 1 |
| Partial thromboplastin time | 0/56 (0%) | 0 | 0/64 (0%) | 0 | 0/61 (0%) | 0 | 0/12 (0%) | 0 | 0/66 (0%) | 0 | 0/63 (0%) | 0 | 1/52 (1.9%) | 1 |
| Platelets | 4/56 (7.1%) | 4 | 3/64 (4.7%) | 3 | 1/61 (1.6%) | 1 | 0/12 (0%) | 0 | 0/66 (0%) | 0 | 3/63 (4.8%) | 4 | 0/52 (0%) | 0 |
| SGOT (AST) | 0/56 (0%) | 0 | 0/64 (0%) | 0 | 1/61 (1.6%) | 1 | 0/12 (0%) | 0 | 1/66 (1.5%) | 2 | 0/63 (0%) | 0 | 1/52 (1.9%) | 1 |
| SGPT (ALT) | 1/56 (1.8%) | 2 | 1/64 (1.6%) | 1 | 2/61 (3.3%) | 2 | 0/12 (0%) | 0 | 1/66 (1.5%) | 2 | 2/63 (3.2%) | 4 | 1/52 (1.9%) | 1 |
| Nervous system disorders | ||||||||||||||
| CNS cerebrovascular ischemia | 0/56 (0%) | 0 | 0/64 (0%) | 0 | 1/61 (1.6%) | 1 | 0/12 (0%) | 0 | 0/66 (0%) | 0 | 0/63 (0%) | 0 | 0/52 (0%) | 0 |
| Cortical blindness, Anxiety, agitation | 0/56 (0%) | 0 | 0/64 (0%) | 0 | 0/61 (0%) | 0 | 0/12 (0%) | 0 | 1/66 (1.5%) | 1 | 0/63 (0%) | 0 | 0/52 (0%) | 0 |
| Lt Hemiplegia | 0/56 (0%) | 0 | 0/64 (0%) | 0 | 1/61 (1.6%) | 1 | 0/12 (0%) | 0 | 0/66 (0%) | 0 | 0/63 (0%) | 0 | 0/52 (0%) | 0 |
| Seizure | 0/56 (0%) | 0 | 2/64 (3.1%) | 2 | 1/61 (1.6%) | 1 | 0/12 (0%) | 0 | 1/66 (1.5%) | 1 | 1/63 (1.6%) | 1 | 0/52 (0%) | 0 |
| difficulty with speech, Left sided numbness | 0/56 (0%) | 0 | 0/64 (0%) | 0 | 1/61 (1.6%) | 1 | 0/12 (0%) | 0 | 0/66 (0%) | 0 | 0/63 (0%) | 0 | 0/52 (0%) | 0 |
| Vascular disorders | ||||||||||||||
| Clot | 0/56 (0%) | 0 | 0/64 (0%) | 0 | 0/61 (0%) | 0 | 0/12 (0%) | 0 | 0/66 (0%) | 0 | 1/63 (1.6%) | 1 | 0/52 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||||||||||||
| A0 (Localized Disease Stg I/II) Modified CCG BFM | A1 (Disseminated, No CNS - CCG Mod BFM w/Out Intens | A2 (Disseminated, No CNS - CCG Mod BFM w/Intens | B2 (CNS+) NHL/BFM-95 w/Intens Delayed Radiation Therapy | B2 (Disseminated,CNS- (< Amend 7B)) NHL/BFM-95 w/Intens | B1 (Disseminated CNS-) NHL/BFM-95 w/Out Intens | B1 (NHL/BFM-95 w/Out Intens) Additional Enrollment | ||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 56/56 (100%) | 64/64 (100%) | 60/61 (98.4%) | 10/12 (83.3%) | 66/66 (100%) | 62/63 (98.4%) | 52/52 (100%) | |||||||
| Blood and lymphatic system disorders | ||||||||||||||
| Hemoglobin (Hgb) | 56/56 (100%) | 509 | 64/64 (100%) | 533 | 60/61 (98.4%) | 520 | 10/12 (83.3%) | 69 | 66/66 (100%) | 530 | 62/63 (98.4%) | 496 | 52/52 (100%) | 476 |
| Hemolysis | 0/56 (0%) | 0 | 1/64 (1.6%) | 1 | 0/61 (0%) | 0 | 0/12 (0%) | 0 | 0/66 (0%) | 0 | 0/63 (0%) | 0 | 0/52 (0%) | 0 |
| Transfusion: Platelets | 19/56 (33.9%) | 28 | 14/64 (21.9%) | 24 | 18/61 (29.5%) | 21 | 3/12 (25%) | 5 | 14/66 (21.2%) | 22 | 12/63 (19%) | 15 | 9/52 (17.3%) | 12 |
| Transfusion: pRBCs | 24/56 (42.9%) | 40 | 29/64 (45.3%) | 54 | 25/61 (41%) | 42 | 3/12 (25%) | 7 | 30/66 (45.5%) | 51 | 27/63 (42.9%) | 45 | 28/52 (53.8%) | 30 |
| Blood/Bone Marrow | 1/56 (1.8%) | 1 | 0/64 (0%) | 0 | 3/61 (4.9%) | 3 | 0/12 (0%) | 0 | 0/66 (0%) | 0 | 1/63 (1.6%) | 1 | 0/52 (0%) | 0 |
| DIC (disseminated intravascular coagulation) | 0/56 (0%) | 0 | 1/64 (1.6%) | 1 | 2/61 (3.3%) | 2 | 0/12 (0%) | 0 | 0/66 (0%) | 0 | 0/63 (0%) | 0 | 1/52 (1.9%) | 1 |
| Febrile neutropenia | 56/56 (100%) | 451 | 62/64 (96.9%) | 490 | 59/61 (96.7%) | 472 | 10/12 (83.3%) | 66 | 64/66 (97%) | 486 | 62/63 (98.4%) | 446 | 52/52 (100%) | 476 |
| Lymphatics | 0/56 (0%) | 0 | 0/64 (0%) | 0 | 0/61 (0%) | 0 | 0/12 (0%) | 0 | 1/66 (1.5%) | 1 | 0/63 (0%) | 0 | 0/52 (0%) | 0 |
| Cardiac disorders | ||||||||||||||
| Palpitations | 0/56 (0%) | 0 | 1/64 (1.6%) | 3 | 0/61 (0%) | 0 | 0/12 (0%) | 0 | 0/66 (0%) | 0 | 0/63 (0%) | 0 | 1/52 (1.9%) | 1 |
| Sinus bradycardia | 0/56 (0%) | 0 | 0/64 (0%) | 0 | 0/61 (0%) | 0 | 0/12 (0%) | 0 | 1/66 (1.5%) | 1 | 0/63 (0%) | 0 | 0/52 (0%) | 0 |
| Sinus tachycardia | 1/56 (1.8%) | 1 | 1/64 (1.6%) | 1 | 2/61 (3.3%) | 3 | 0/12 (0%) | 0 | 2/66 (3%) | 2 | 1/63 (1.6%) | 1 | 2/52 (3.8%) | 2 |
| Cardiovascular/Arrhythmia | 48/56 (85.7%) | 406 | 59/64 (92.2%) | 469 | 56/61 (91.8%) | 458 | 10/12 (83.3%) | 63 | 60/66 (90.9%) | 475 | 60/63 (95.2%) | 427 | 52/52 (100%) | 476 |
| Cardiac left ventricular function | 52/56 (92.9%) | 428 | 61/64 (95.3%) | 482 | 56/61 (91.8%) | 462 | 10/12 (83.3%) | 62 | 61/66 (92.4%) | 482 | 61/63 (96.8%) | 436 | 52/52 (100%) | 476 |
| Edema | 0/56 (0%) | 0 | 2/64 (3.1%) | 2 | 0/61 (0%) | 0 | 0/12 (0%) | 0 | 1/66 (1.5%) | 1 | 1/63 (1.6%) | 1 | 0/52 (0%) | 0 |
| Pericardial effusion/pericarditis | 0/56 (0%) | 0 | 0/64 (0%) | 0 | 2/61 (3.3%) | 2 | 0/12 (0%) | 0 | 2/66 (3%) | 2 | 0/63 (0%) | 0 | 0/52 (0%) | 0 |
| Cardiovascular/General | 0/56 (0%) | 0 | 0/64 (0%) | 0 | 1/61 (1.6%) | 1 | 0/12 (0%) | 0 | 0/66 (0%) | 0 | 1/63 (1.6%) | 1 | 0/52 (0%) | 0 |
| Ear and labyrinth disorders | ||||||||||||||
| Inner ear/hearing | 0/56 (0%) | 0 | 0/64 (0%) | 0 | 0/61 (0%) | 0 | 0/12 (0%) | 0 | 0/66 (0%) | 0 | 0/63 (0%) | 0 | 1/52 (1.9%) | 1 |
| Middle ear/hearing | 0/56 (0%) | 0 | 0/64 (0%) | 0 | 1/61 (1.6%) | 1 | 1/12 (8.3%) | 1 | 1/66 (1.5%) | 1 | 1/63 (1.6%) | 1 | 0/52 (0%) | 0 |
| Auditory/Hearing | 0/56 (0%) | 0 | 1/64 (1.6%) | 1 | 0/61 (0%) | 0 | 0/12 (0%) | 0 | 0/66 (0%) | 0 | 0/63 (0%) | 0 | 0/52 (0%) | 0 |
| Earache (otalgia) | 0/56 (0%) | 0 | 3/64 (4.7%) | 3 | 0/61 (0%) | 0 | 1/12 (8.3%) | 2 | 0/66 (0%) | 0 | 3/63 (4.8%) | 3 | 1/52 (1.9%) | 1 |
| Endocrine disorders | ||||||||||||||
| Cushingoid appearance | 0/56 (0%) | 0 | 0/64 (0%) | 0 | 3/61 (4.9%) | 3 | 1/12 (8.3%) | 2 | 2/66 (3%) | 4 | 1/63 (1.6%) | 1 | 1/52 (1.9%) | 1 |
| Endocrine | 0/56 (0%) | 0 | 2/64 (3.1%) | 2 | 1/61 (1.6%) | 1 | 0/12 (0%) | 0 | 0/66 (0%) | 0 | 0/63 (0%) | 0 | 6/52 (11.5%) | 6 |
| Eye disorders | ||||||||||||||
| Conjunctivitis | 0/56 (0%) | 0 | 0/64 (0%) | 0 | 0/61 (0%) | 0 | 1/12 (8.3%) | 1 | 0/66 (0%) | 0 | 2/63 (3.2%) | 2 | 0/52 (0%) | 0 |
| Tearing (watery eyes) | 0/56 (0%) | 0 | 0/64 (0%) | 0 | 0/61 (0%) | 0 | 0/12 (0%) | 0 | 0/66 (0%) | 0 | 0/63 (0%) | 0 | 1/52 (1.9%) | 1 |
| Vision-blurred vision | 0/56 (0%) | 0 | 1/64 (1.6%) | 1 | 0/61 (0%) | 0 | 0/12 (0%) | 0 | 0/66 (0%) | 0 | 0/63 (0%) | 0 | 1/52 (1.9%) | 1 |
| Vision-photophobia | 0/56 (0%) | 0 | 1/64 (1.6%) | 1 | 0/61 (0%) | 0 | 1/12 (8.3%) | 1 | 0/66 (0%) | 0 | 0/63 (0%) | 0 | 0/52 (0%) | 0 |
| Ocular/Visual | 0/56 (0%) | 0 | 1/64 (1.6%) | 1 | 0/61 (0%) | 0 | 0/12 (0%) | 0 | 0/66 (0%) | 0 | 1/63 (1.6%) | 1 | 0/52 (0%) | 0 |
| Gastrointestinal disorders | ||||||||||||||
| Colitis | 0/56 (0%) | 0 | 2/64 (3.1%) | 2 | 0/61 (0%) | 0 | 0/12 (0%) | 0 | 1/66 (1.5%) | 1 | 0/63 (0%) | 0 | 1/52 (1.9%) | 1 |
| Constipation | 2/56 (3.6%) | 2 | 7/64 (10.9%) | 13 | 5/61 (8.2%) | 7 | 0/12 (0%) | 0 | 8/66 (12.1%) | 9 | 7/63 (11.1%) | 9 | 4/52 (7.7%) | 4 |
| Diarrhea (without colostomy) | 7/56 (12.5%) | 7 | 7/64 (10.9%) | 13 | 7/61 (11.5%) | 9 | 0/12 (0%) | 0 | 4/66 (6.1%) | 6 | 9/63 (14.3%) | 11 | 3/52 (5.8%) | 4 |
| Dyspepsia/heartburn | 0/56 (0%) | 0 | 0/64 (0%) | 0 | 0/61 (0%) | 0 | 0/12 (0%) | 0 | 1/66 (1.5%) | 2 | 1/63 (1.6%) | 1 | 0/52 (0%) | 0 |
| Dysphagia, esophagitis, odynophagia (painful swallowing) | 0/56 (0%) | 0 | 1/64 (1.6%) | 1 | 0/61 (0%) | 0 | 0/12 (0%) | 0 | 2/66 (3%) | 3 | 3/63 (4.8%) | 5 | 2/52 (3.8%) | 3 |
| Fistula-intestinal | 0/56 (0%) | 0 | 1/64 (1.6%) | 1 | 1/61 (1.6%) | 1 | 0/12 (0%) | 0 | 0/66 (0%) | 0 | 0/63 (0%) | 0 | 0/52 (0%) | 0 |
| Fistula-rectal/anal | 0/56 (0%) | 0 | 1/64 (1.6%) | 1 | 0/61 (0%) | 0 | 0/12 (0%) | 0 | 0/66 (0%) | 0 | 0/63 (0%) | 0 | 0/52 (0%) | 0 |
| Gastric ulcer | 0/56 (0%) | 0 | 1/64 (1.6%) | 1 | 1/61 (1.6%) | 1 | 0/12 (0%) | 0 | 0/66 (0%) | 0 | 0/63 (0%) | 0 | 0/52 (0%) | 0 |
| Gastritis | 0/56 (0%) | 0 | 3/64 (4.7%) | 3 | 1/61 (1.6%) | 1 | 0/12 (0%) | 0 | 1/66 (1.5%) | 1 | 1/63 (1.6%) | 1 | 1/52 (1.9%) | 1 |
| Ileus | 1/56 (1.8%) | 2 | 1/64 (1.6%) | 1 | 1/61 (1.6%) | 1 | 0/12 (0%) | 0 | 6/66 (9.1%) | 6 | 0/63 (0%) | 0 | 1/52 (1.9%) | 1 |
| Mouth dryness | 0/56 (0%) | 0 | 1/64 (1.6%) | 1 | 0/61 (0%) | 0 | 0/12 (0%) | 0 | 0/66 (0%) | 0 | 0/63 (0%) | 0 | 0/52 (0%) | 0 |
| Nausea | 6/56 (10.7%) | 8 | 9/64 (14.1%) | 16 | 5/61 (8.2%) | 14 | 1/12 (8.3%) | 1 | 9/66 (13.6%) | 14 | 8/63 (12.7%) | 11 | 8/52 (15.4%) | 10 |
| Pancreatitis | 52/56 (92.9%) | 431 | 61/64 (95.3%) | 481 | 56/61 (91.8%) | 458 | 10/12 (83.3%) | 62 | 63/66 (95.5%) | 481 | 61/63 (96.8%) | 436 | 52/52 (100%) | 476 |
| Proctitis | 0/56 (0%) | 0 | 0/64 (0%) | 0 | 1/61 (1.6%) | 1 | 0/12 (0%) | 0 | 0/66 (0%) | 0 | 1/63 (1.6%) | 1 | 0/52 (0%) | 0 |
| Stomatitis/pharyngitis (oral/pharyngeal mucositis) | 4/56 (7.1%) | 7 | 9/64 (14.1%) | 13 | 7/61 (11.5%) | 11 | 2/12 (16.7%) | 2 | 17/66 (25.8%) | 21 | 20/63 (31.7%) | 24 | 15/52 (28.8%) | 19 |
| Typhlitis (inflammation of cecum) | 0/56 (0%) | 0 | 2/64 (3.1%) | 2 | 2/61 (3.3%) | 3 | 0/12 (0%) | 0 | 2/66 (3%) | 2 | 0/63 (0%) | 0 | 1/52 (1.9%) | 1 |
| Vomiting | 8/56 (14.3%) | 12 | 7/64 (10.9%) | 15 | 8/61 (13.1%) | 11 | 1/12 (8.3%) | 1 | 11/66 (16.7%) | 18 | 12/63 (19%) | 17 | 6/52 (11.5%) | 9 |
| Gastrointestinal | 0/56 (0%) | 0 | 3/64 (4.7%) | 4 | 0/61 (0%) | 0 | 0/12 (0%) | 0 | 0/66 (0%) | 0 | 0/63 (0%) | 0 | 3/52 (5.8%) | 3 |
| Hematemesis | 0/56 (0%) | 0 | 1/64 (1.6%) | 1 | 1/61 (1.6%) | 1 | 0/12 (0%) | 0 | 0/66 (0%) | 0 | 1/63 (1.6%) | 1 | 0/52 (0%) | 0 |
| Melena/GI bleeding | 1/56 (1.8%) | 1 | 1/64 (1.6%) | 1 | 1/61 (1.6%) | 1 | 0/12 (0%) | 0 | 0/66 (0%) | 0 | 0/63 (0%) | 0 | 0/52 (0%) | 0 |
| Rectal bleeding/hematochezia | 0/56 (0%) | 0 | 0/64 (0%) | 0 | 1/61 (1.6%) | 1 | 0/12 (0%) | 0 | 0/66 (0%) | 0 | 0/63 (0%) | 0 | 0/52 (0%) | 0 |
| Abdominal pain or cramping | 2/56 (3.6%) | 5 | 6/64 (9.4%) | 10 | 7/61 (11.5%) | 8 | 1/12 (8.3%) | 1 | 13/66 (19.7%) | 13 | 4/63 (6.3%) | 5 | 4/52 (7.7%) | 4 |
| Rectal or perirectal pain | 1/56 (1.8%) | 1 | 2/64 (3.1%) | 2 | 0/61 (0%) | 0 | 0/12 (0%) | 0 | 0/66 (0%) | 0 | 0/63 (0%) | 0 | 1/52 (1.9%) | 1 |
| General disorders | ||||||||||||||
| Fatigue (lethargy, malaise, asthenia) | 3/56 (5.4%) | 6 | 3/64 (4.7%) | 7 | 4/61 (6.6%) | 5 | 2/12 (16.7%) | 2 | 5/66 (7.6%) | 7 | 1/63 (1.6%) | 2 | 2/52 (3.8%) | 2 |
| Fever | 5/56 (8.9%) | 7 | 2/64 (3.1%) | 3 | 5/61 (8.2%) | 7 | 0/12 (0%) | 0 | 6/66 (9.1%) | 8 | 12/63 (19%) | 16 | 4/52 (7.7%) | 4 |
| Rigors, chills | 0/56 (0%) | 0 | 0/64 (0%) | 0 | 0/61 (0%) | 0 | 0/12 (0%) | 0 | 1/66 (1.5%) | 1 | 0/63 (0%) | 0 | 0/52 (0%) | 0 |
| Weight gain | 1/56 (1.8%) | 2 | 5/64 (7.8%) | 14 | 1/61 (1.6%) | 2 | 0/12 (0%) | 0 | 0/66 (0%) | 0 | 1/63 (1.6%) | 1 | 1/52 (1.9%) | 1 |
| Weight loss | 0/56 (0%) | 0 | 2/64 (3.1%) | 4 | 4/61 (6.6%) | 4 | 1/12 (8.3%) | 1 | 3/66 (4.5%) | 3 | 2/63 (3.2%) | 2 | 1/52 (1.9%) | 1 |
| Constitutional Symptoms | 0/56 (0%) | 0 | 0/64 (0%) | 0 | 1/61 (1.6%) | 2 | 0/12 (0%) | 0 | 1/66 (1.5%) | 1 | 1/63 (1.6%) | 1 | 0/52 (0%) | 0 |
| Injection site reaction | 0/56 (0%) | 0 | 0/64 (0%) | 0 | 0/61 (0%) | 0 | 0/12 (0%) | 0 | 1/66 (1.5%) | 1 | 0/63 (0%) | 0 | 0/52 (0%) | 0 |
| Insomnia | 0/56 (0%) | 0 | 2/64 (3.1%) | 2 | 0/61 (0%) | 0 | 0/12 (0%) | 0 | 1/66 (1.5%) | 1 | 2/63 (3.2%) | 3 | 0/52 (0%) | 0 |
| Arthralgia (joint pain) | 2/56 (3.6%) | 2 | 3/64 (4.7%) | 3 | 0/61 (0%) | 0 | 1/12 (8.3%) | 1 | 2/66 (3%) | 2 | 0/63 (0%) | 0 | 2/52 (3.8%) | 2 |
| Bone pain | 0/56 (0%) | 0 | 3/64 (4.7%) | 3 | 3/61 (4.9%) | 5 | 0/12 (0%) | 0 | 1/66 (1.5%) | 1 | 1/63 (1.6%) | 2 | 1/52 (1.9%) | 1 |
| Chest pain (non-cardiac and non-pleuritic) | 0/56 (0%) | 0 | 1/64 (1.6%) | 1 | 2/61 (3.3%) | 2 | 1/12 (8.3%) | 1 | 1/66 (1.5%) | 1 | 0/63 (0%) | 0 | 1/52 (1.9%) | 1 |
| Headache | 3/56 (5.4%) | 6 | 9/64 (14.1%) | 23 | 9/61 (14.8%) | 10 | 3/12 (25%) | 5 | 5/66 (7.6%) | 11 | 5/63 (7.9%) | 7 | 5/52 (9.6%) | 5 |
| Myalgia (muscle pain) | 2/56 (3.6%) | 2 | 5/64 (7.8%) | 8 | 2/61 (3.3%) | 2 | 0/12 (0%) | 0 | 4/66 (6.1%) | 4 | 2/63 (3.2%) | 2 | 1/52 (1.9%) | 1 |
| Neuropathic pain | 1/56 (1.8%) | 2 | 5/64 (7.8%) | 8 | 5/61 (8.2%) | 6 | 2/12 (16.7%) | 3 | 7/66 (10.6%) | 7 | 7/63 (11.1%) | 11 | 2/52 (3.8%) | 2 |
| Pelvic pain | 0/56 (0%) | 0 | 0/64 (0%) | 0 | 0/61 (0%) | 0 | 0/12 (0%) | 0 | 0/66 (0%) | 0 | 0/63 (0%) | 0 | 1/52 (1.9%) | 2 |
| Pleuritic pain | 0/56 (0%) | 0 | 0/64 (0%) | 0 | 0/61 (0%) | 0 | 0/12 (0%) | 0 | 1/66 (1.5%) | 2 | 0/63 (0%) | 0 | 1/52 (1.9%) | 1 |
| Tumor pain | 0/56 (0%) | 0 | 0/64 (0%) | 0 | 0/61 (0%) | 0 | 0/12 (0%) | 0 | 1/66 (1.5%) | 1 | 0/63 (0%) | 0 | 0/52 (0%) | 0 |
| Pain | 2/56 (3.6%) | 2 | 6/64 (9.4%) | 7 | 5/61 (8.2%) | 7 | 1/12 (8.3%) | 1 | 8/66 (12.1%) | 11 | 9/63 (14.3%) | 11 | 5/52 (9.6%) | 7 |
| Syndromes | 0/56 (0%) | 0 | 0/64 (0%) | 0 | 0/61 (0%) | 0 | 0/12 (0%) | 0 | 0/66 (0%) | 0 | 0/63 (0%) | 0 | 1/52 (1.9%) | 1 |
| Hepatobiliary disorders | ||||||||||||||
| Hepatic enlargement | 1/56 (1.8%) | 1 | 0/64 (0%) | 0 | 0/61 (0%) | 0 | 0/12 (0%) | 0 | 0/66 (0%) | 0 | 0/63 (0%) | 0 | 0/52 (0%) | 0 |
| Hepatic | 0/56 (0%) | 0 | 1/64 (1.6%) | 5 | 1/61 (1.6%) | 1 | 0/12 (0%) | 0 | 1/66 (1.5%) | 1 | 0/63 (0%) | 0 | 0/52 (0%) | 0 |
| Immune system disorders | ||||||||||||||
| Allergic reaction/hypersensitivity | 1/56 (1.8%) | 2 | 4/64 (6.3%) | 5 | 1/61 (1.6%) | 1 | 1/12 (8.3%) | 1 | 3/66 (4.5%) | 4 | 3/63 (4.8%) | 3 | 1/52 (1.9%) | 1 |
| Autoimmune reaction | 0/56 (0%) | 0 | 1/64 (1.6%) | 1 | 0/61 (0%) | 0 | 0/12 (0%) | 0 | 1/66 (1.5%) | 1 | 1/63 (1.6%) | 1 | 0/52 (0%) | 0 |
| Allergy/Immunology | 0/56 (0%) | 0 | 1/64 (1.6%) | 1 | 2/61 (3.3%) | 2 | 0/12 (0%) | 0 | 0/66 (0%) | 0 | 0/63 (0%) | 0 | 0/52 (0%) | 0 |
| Infections and infestations | ||||||||||||||
| Wound-infectious | 0/56 (0%) | 0 | 1/64 (1.6%) | 2 | 0/61 (0%) | 0 | 0/12 (0%) | 0 | 1/66 (1.5%) | 1 | 1/63 (1.6%) | 1 | 3/52 (5.8%) | 3 |
| Catheter-related infection | 51/56 (91.1%) | 430 | 63/64 (98.4%) | 483 | 58/61 (95.1%) | 460 | 10/12 (83.3%) | 62 | 63/66 (95.5%) | 481 | 62/63 (98.4%) | 443 | 52/52 (100%) | 476 |
| Infection (documented clinically or microbiologically) with grade 3 or 4 neutropenia | 54/56 (96.4%) | 441 | 63/64 (98.4%) | 488 | 59/61 (96.7%) | 469 | 10/12 (83.3%) | 64 | 64/66 (97%) | 488 | 62/63 (98.4%) | 440 | 52/52 (100%) | 476 |
| Infection with unknown ANC | 0/56 (0%) | 0 | 1/64 (1.6%) | 1 | 1/61 (1.6%) | 1 | 0/12 (0%) | 0 | 0/66 (0%) | 0 | 2/63 (3.2%) | 2 | 0/52 (0%) | 0 |
| Infection without neutropenia | 53/56 (94.6%) | 438 | 63/64 (98.4%) | 485 | 57/61 (93.4%) | 461 | 10/12 (83.3%) | 62 | 63/66 (95.5%) | 488 | 61/63 (96.8%) | 445 | 52/52 (100%) | 476 |
| Infection/Febrile Neutropenia | 50/56 (89.3%) | 410 | 58/64 (90.6%) | 467 | 58/61 (95.1%) | 460 | 10/12 (83.3%) | 65 | 60/66 (90.9%) | 473 | 60/63 (95.2%) | 425 | 52/52 (100%) | 476 |
| Injury, poisoning and procedural complications | ||||||||||||||
| Wound-non infectious | 0/56 (0%) | 0 | 0/64 (0%) | 0 | 1/61 (1.6%) | 1 | 0/12 (0%) | 0 | 0/66 (0%) | 0 | 1/63 (1.6%) | 1 | 0/52 (0%) | 0 |
| Investigations | ||||||||||||||
| Leukocytes (total WBC) | 56/56 (100%) | 532 | 64/64 (100%) | 552 | 60/61 (98.4%) | 536 | 10/12 (83.3%) | 72 | 66/66 (100%) | 556 | 62/63 (98.4%) | 505 | 52/52 (100%) | 476 |
| Lymphopenia | 12/56 (21.4%) | 40 | 13/64 (20.3%) | 52 | 10/61 (16.4%) | 40 | 1/12 (8.3%) | 5 | 15/66 (22.7%) | 39 | 8/63 (12.7%) | 26 | 9/52 (17.3%) | 29 |
| Neutrophils/granulocytes (ANC/AGC) | 28/56 (50%) | 86 | 45/64 (70.3%) | 139 | 40/61 (65.6%) | 116 | 5/12 (41.7%) | 14 | 36/66 (54.5%) | 114 | 37/63 (58.7%) | 98 | 27/52 (51.9%) | 79 |
| Platelets | 56/56 (100%) | 469 | 64/64 (100%) | 523 | 60/61 (98.4%) | 499 | 10/12 (83.3%) | 69 | 66/66 (100%) | 520 | 61/63 (96.8%) | 468 | 52/52 (100%) | 476 |
| Fibrinogen | 3/56 (5.4%) | 4 | 3/64 (4.7%) | 3 | 4/61 (6.6%) | 4 | 0/12 (0%) | 0 | 6/66 (9.1%) | 6 | 7/63 (11.1%) | 7 | 4/52 (7.7%) | 5 |
| Partial thromboplastin time (PTT) | 0/56 (0%) | 0 | 2/64 (3.1%) | 2 | 3/61 (4.9%) | 3 | 0/12 (0%) | 0 | 3/66 (4.5%) | 3 | 2/63 (3.2%) | 4 | 0/52 (0%) | 0 |
| Prothrombin time (PT) | 1/56 (1.8%) | 1 | 1/64 (1.6%) | 2 | 1/61 (1.6%) | 1 | 0/12 (0%) | 0 | 3/66 (4.5%) | 3 | 4/63 (6.3%) | 5 | 0/52 (0%) | 0 |
| Coagulation | 1/56 (1.8%) | 1 | 2/64 (3.1%) | 2 | 1/61 (1.6%) | 1 | 0/12 (0%) | 0 | 1/66 (1.5%) | 2 | 1/63 (1.6%) | 1 | 0/52 (0%) | 0 |
| SIADH (syndrome of inappropriate antidiuretic hormone) | 0/56 (0%) | 0 | 1/64 (1.6%) | 1 | 1/61 (1.6%) | 1 | 0/12 (0%) | 0 | 1/66 (1.5%) | 1 | 0/63 (0%) | 0 | 2/52 (3.8%) | 2 |
| Alkaline phosphatase | 4/56 (7.1%) | 11 | 2/64 (3.1%) | 2 | 3/61 (4.9%) | 4 | 0/12 (0%) | 0 | 2/66 (3%) | 2 | 3/63 (4.8%) | 5 | 2/52 (3.8%) | 2 |
| Bilirubin | 53/56 (94.6%) | 444 | 61/64 (95.3%) | 492 | 57/61 (93.4%) | 483 | 10/12 (83.3%) | 63 | 65/66 (98.5%) | 505 | 62/63 (98.4%) | 454 | 52/52 (100%) | 476 |
| GGT | 1/56 (1.8%) | 3 | 3/64 (4.7%) | 9 | 3/61 (4.9%) | 3 | 0/12 (0%) | 0 | 1/66 (1.5%) | 1 | 2/63 (3.2%) | 6 | 0/52 (0%) | 0 |
| SGOT (AST) | 54/56 (96.4%) | 469 | 62/64 (96.9%) | 502 | 59/61 (96.7%) | 492 | 10/12 (83.3%) | 63 | 65/66 (98.5%) | 509 | 62/63 (98.4%) | 468 | 52/52 (100%) | 476 |
| SGPT (ALT) | 54/56 (96.4%) | 487 | 63/64 (98.4%) | 516 | 59/61 (96.7%) | 505 | 10/12 (83.3%) | 67 | 65/66 (98.5%) | 520 | 62/63 (98.4%) | 482 | 52/52 (100%) | 476 |
| Amylase | 0/56 (0%) | 0 | 3/64 (4.7%) | 3 | 3/61 (4.9%) | 3 | 1/12 (8.3%) | 1 | 1/66 (1.5%) | 1 | 4/63 (6.3%) | 6 | 0/52 (0%) | 0 |
| Hypercholesterolemia | 1/56 (1.8%) | 1 | 1/64 (1.6%) | 1 | 1/61 (1.6%) | 1 | 0/12 (0%) | 0 | 1/66 (1.5%) | 1 | 0/63 (0%) | 0 | 1/52 (1.9%) | 1 |
| Lipase | 0/56 (0%) | 0 | 1/64 (1.6%) | 1 | 2/61 (3.3%) | 2 | 1/12 (8.3%) | 1 | 4/66 (6.1%) | 4 | 2/63 (3.2%) | 2 | 0/52 (0%) | 0 |
| Metabolic/Laboratory | 3/56 (5.4%) | 7 | 0/64 (0%) | 0 | 3/61 (4.9%) | 3 | 0/12 (0%) | 0 | 3/66 (4.5%) | 3 | 2/63 (3.2%) | 4 | 4/52 (7.7%) | 4 |
| Serum Creatinine | 51/56 (91.1%) | 438 | 62/64 (96.9%) | 482 | 57/61 (93.4%) | 467 | 10/12 (83.3%) | 62 | 63/66 (95.5%) | 492 | 61/63 (96.8%) | 450 | 52/52 (100%) | 476 |
| Metabolism and nutrition disorders | ||||||||||||||
| Anorexia | 2/56 (3.6%) | 2 | 7/64 (10.9%) | 7 | 5/61 (8.2%) | 9 | 0/12 (0%) | 0 | 7/66 (10.6%) | 12 | 2/63 (3.2%) | 2 | 0/52 (0%) | 0 |
| Dehydration | 1/56 (1.8%) | 1 | 7/64 (10.9%) | 7 | 4/61 (6.6%) | 4 | 0/12 (0%) | 0 | 7/66 (10.6%) | 10 | 8/63 (12.7%) | 10 | 3/52 (5.8%) | 8 |
| Hypoalbuminemia | 8/56 (14.3%) | 12 | 5/64 (7.8%) | 9 | 7/61 (11.5%) | 9 | 0/12 (0%) | 0 | 6/66 (9.1%) | 7 | 4/63 (6.3%) | 5 | 4/52 (7.7%) | 4 |
| Acidosis (metabolic or respiratory) | 0/56 (0%) | 0 | 0/64 (0%) | 0 | 1/61 (1.6%) | 1 | 0/12 (0%) | 0 | 1/66 (1.5%) | 1 | 0/63 (0%) | 0 | 1/52 (1.9%) | 1 |
| Bicarbonate | 3/56 (5.4%) | 4 | 2/64 (3.1%) | 2 | 1/61 (1.6%) | 1 | 0/12 (0%) | 0 | 1/66 (1.5%) | 1 | 1/63 (1.6%) | 1 | 0/52 (0%) | 0 |
| Hypercalcemia | 0/56 (0%) | 0 | 0/64 (0%) | 0 | 4/61 (6.6%) | 4 | 0/12 (0%) | 0 | 1/66 (1.5%) | 1 | 2/63 (3.2%) | 6 | 1/52 (1.9%) | 1 |
| Hyperglycemia | 7/56 (12.5%) | 15 | 13/64 (20.3%) | 27 | 13/61 (21.3%) | 25 | 2/12 (16.7%) | 3 | 13/66 (19.7%) | 20 | 16/63 (25.4%) | 30 | 14/52 (26.9%) | 29 |
| Hyperkalemia | 2/56 (3.6%) | 2 | 4/64 (6.3%) | 7 | 2/61 (3.3%) | 2 | 1/12 (8.3%) | 1 | 6/66 (9.1%) | 8 | 2/63 (3.2%) | 2 | 2/52 (3.8%) | 2 |
| Hypermagnesemia | 1/56 (1.8%) | 2 | 2/64 (3.1%) | 3 | 4/61 (6.6%) | 4 | 0/12 (0%) | 0 | 2/66 (3%) | 2 | 0/63 (0%) | 0 | 1/52 (1.9%) | 1 |
| Hypernatremia | 1/56 (1.8%) | 1 | 2/64 (3.1%) | 2 | 3/61 (4.9%) | 4 | 0/12 (0%) | 0 | 1/66 (1.5%) | 2 | 4/63 (6.3%) | 7 | 3/52 (5.8%) | 3 |
| Hypertriglyceridemia | 0/56 (0%) | 0 | 2/64 (3.1%) | 2 | 1/61 (1.6%) | 2 | 0/12 (0%) | 0 | 0/66 (0%) | 0 | 0/63 (0%) | 0 | 0/52 (0%) | 0 |
| Hyperuricemia | 1/56 (1.8%) | 1 | 0/64 (0%) | 0 | 2/61 (3.3%) | 5 | 1/12 (8.3%) | 1 | 0/66 (0%) | 0 | 5/63 (7.9%) | 6 | 1/52 (1.9%) | 1 |
| Hypocalcemia | 7/56 (12.5%) | 11 | 7/64 (10.9%) | 9 | 10/61 (16.4%) | 17 | 2/12 (16.7%) | 2 | 13/66 (19.7%) | 13 | 9/63 (14.3%) | 12 | 9/52 (17.3%) | 16 |
| Hypoglycemia | 1/56 (1.8%) | 1 | 2/64 (3.1%) | 3 | 2/61 (3.3%) | 2 | 0/12 (0%) | 0 | 4/66 (6.1%) | 4 | 1/63 (1.6%) | 2 | 2/52 (3.8%) | 2 |
| Hypokalemia | 10/56 (17.9%) | 19 | 8/64 (12.5%) | 15 | 11/61 (18%) | 20 | 0/12 (0%) | 0 | 10/66 (15.2%) | 11 | 13/63 (20.6%) | 15 | 19/52 (36.5%) | 27 |
| Hypomagnesemia | 2/56 (3.6%) | 2 | 5/64 (7.8%) | 6 | 2/61 (3.3%) | 4 | 0/12 (0%) | 0 | 3/66 (4.5%) | 3 | 1/63 (1.6%) | 1 | 1/52 (1.9%) | 2 |
| Hyponatremia | 6/56 (10.7%) | 10 | 5/64 (7.8%) | 6 | 7/61 (11.5%) | 10 | 1/12 (8.3%) | 1 | 13/66 (19.7%) | 15 | 10/63 (15.9%) | 13 | 20/52 (38.5%) | 26 |
| Hypophosphatemia | 5/56 (8.9%) | 8 | 5/64 (7.8%) | 6 | 4/61 (6.6%) | 6 | 0/12 (0%) | 0 | 7/66 (10.6%) | 7 | 6/63 (9.5%) | 6 | 4/52 (7.7%) | 4 |
| Urinary electrolyte wasting | 0/56 (0%) | 0 | 0/64 (0%) | 0 | 0/61 (0%) | 0 | 0/12 (0%) | 0 | 1/66 (1.5%) | 1 | 0/63 (0%) | 0 | 0/52 (0%) | 0 |
| Tumor lysis syndrome | 0/56 (0%) | 0 | 1/64 (1.6%) | 1 | 0/61 (0%) | 0 | 0/12 (0%) | 0 | 0/66 (0%) | 0 | 1/63 (1.6%) | 1 | 0/52 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||||||||||||
| Arthritis | 0/56 (0%) | 0 | 2/64 (3.1%) | 2 | 0/61 (0%) | 0 | 0/12 (0%) | 0 | 0/66 (0%) | 0 | 0/63 (0%) | 0 | 0/52 (0%) | 0 |
| Muscle weakness (not due to neuropathy) | 1/56 (1.8%) | 1 | 1/64 (1.6%) | 1 | 0/61 (0%) | 0 | 0/12 (0%) | 0 | 0/66 (0%) | 0 | 1/63 (1.6%) | 2 | 2/52 (3.8%) | 2 |
| Osteonecrosis (avascular necrosis) | 52/56 (92.9%) | 430 | 61/64 (95.3%) | 480 | 57/61 (93.4%) | 460 | 10/12 (83.3%) | 62 | 61/66 (92.4%) | 477 | 61/63 (96.8%) | 435 | 52/52 (100%) | 476 |
| Musculoskeletal | 1/56 (1.8%) | 1 | 1/64 (1.6%) | 1 | 2/61 (3.3%) | 2 | 0/12 (0%) | 0 | 1/66 (1.5%) | 1 | 0/63 (0%) | 0 | 0/52 (0%) | 0 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||||||
| Secondary malignancy - Other (Specify type, excludes metastastic tumors) | 0/56 (0%) | 0 | 0/64 (0%) | 0 | 0/61 (0%) | 0 | 0/12 (0%) | 0 | 1/66 (1.5%) | 1 | 0/63 (0%) | 0 | 0/52 (0%) | 0 |
| Nervous system disorders | ||||||||||||||
| Vasovagal episode | 0/56 (0%) | 0 | 1/64 (1.6%) | 1 | 0/61 (0%) | 0 | 0/12 (0%) | 0 | 0/66 (0%) | 0 | 0/63 (0%) | 0 | 0/52 (0%) | 0 |
| CNS hemorrhage/bleeding | 0/56 (0%) | 0 | 0/64 (0%) | 0 | 1/61 (1.6%) | 1 | 0/12 (0%) | 0 | 0/66 (0%) | 0 | 0/63 (0%) | 0 | 1/52 (1.9%) | 1 |
| Arachnoiditis/meningismus/radiculitis | 0/56 (0%) | 0 | 0/64 (0%) | 0 | 0/61 (0%) | 0 | 0/12 (0%) | 0 | 1/66 (1.5%) | 1 | 0/63 (0%) | 0 | 0/52 (0%) | 0 |
| Ataxia (incoordination) | 1/56 (1.8%) | 1 | 1/64 (1.6%) | 1 | 2/61 (3.3%) | 3 | 0/12 (0%) | 0 | 1/66 (1.5%) | 1 | 1/63 (1.6%) | 1 | 0/52 (0%) | 0 |
| CNS cerebrovascular ischemia | 51/56 (91.1%) | 428 | 61/64 (95.3%) | 482 | 56/61 (91.8%) | 456 | 10/12 (83.3%) | 62 | 61/66 (92.4%) | 478 | 61/63 (96.8%) | 435 | 52/52 (100%) | 476 |
| Depressed level of consciousness | 0/56 (0%) | 0 | 1/64 (1.6%) | 1 | 0/61 (0%) | 0 | 1/12 (8.3%) | 1 | 0/66 (0%) | 0 | 2/63 (3.2%) | 2 | 0/52 (0%) | 0 |
| Dizziness/lightheadedness | 0/56 (0%) | 0 | 3/64 (4.7%) | 5 | 2/61 (3.3%) | 2 | 0/12 (0%) | 0 | 1/66 (1.5%) | 1 | 0/63 (0%) | 0 | 2/52 (3.8%) | 2 |
| Extrapyramidal/involuntary movement/restlessness | 1/56 (1.8%) | 1 | 1/64 (1.6%) | 1 | 0/61 (0%) | 0 | 0/12 (0%) | 0 | 1/66 (1.5%) | 1 | 0/63 (0%) | 0 | 0/52 (0%) | 0 |
| Leukoencephalopathy associated radiological findings | 0/56 (0%) | 0 | 0/64 (0%) | 0 | 1/61 (1.6%) | 1 | 0/12 (0%) | 0 | 2/66 (3%) | 2 | 0/63 (0%) | 0 | 1/52 (1.9%) | 1 |
| Memory loss | 0/56 (0%) | 0 | 0/64 (0%) | 0 | 0/61 (0%) | 0 | 0/12 (0%) | 0 | 1/66 (1.5%) | 1 | 0/63 (0%) | 0 | 0/52 (0%) | 0 |
| Neuropathy - cranial | 0/56 (0%) | 0 | 0/64 (0%) | 0 | 1/61 (1.6%) | 1 | 0/12 (0%) | 0 | 0/66 (0%) | 0 | 2/63 (3.2%) | 2 | 1/52 (1.9%) | 1 |
| Neuropathy - motor | 3/56 (5.4%) | 3 | 4/64 (6.3%) | 5 | 7/61 (11.5%) | 7 | 0/12 (0%) | 0 | 9/66 (13.6%) | 11 | 5/63 (7.9%) | 5 | 3/52 (5.8%) | 3 |
| Neuropathy - sensory | 0/56 (0%) | 0 | 3/64 (4.7%) | 3 | 3/61 (4.9%) | 3 | 0/12 (0%) | 0 | 6/66 (9.1%) | 7 | 5/63 (7.9%) | 7 | 4/52 (7.7%) | 5 |
| Seizure(s) | 51/56 (91.1%) | 432 | 62/64 (96.9%) | 481 | 56/61 (91.8%) | 456 | 10/12 (83.3%) | 62 | 63/66 (95.5%) | 481 | 61/63 (96.8%) | 437 | 52/52 (100%) | 476 |
| Speech impairment | 0/56 (0%) | 0 | 1/64 (1.6%) | 1 | 2/61 (3.3%) | 2 | 0/12 (0%) | 0 | 2/66 (3%) | 2 | 1/63 (1.6%) | 1 | 2/52 (3.8%) | 2 |
| Syncope (fainting) | 0/56 (0%) | 0 | 3/64 (4.7%) | 5 | 0/61 (0%) | 0 | 0/12 (0%) | 0 | 0/66 (0%) | 0 | 1/63 (1.6%) | 1 | 1/52 (1.9%) | 1 |
| Tremor | 0/56 (0%) | 0 | 1/64 (1.6%) | 1 | 1/61 (1.6%) | 1 | 0/12 (0%) | 0 | 0/66 (0%) | 0 | 0/63 (0%) | 0 | 0/52 (0%) | 0 |
| Vertigo | 0/56 (0%) | 0 | 0/64 (0%) | 0 | 1/61 (1.6%) | 2 | 0/12 (0%) | 0 | 0/66 (0%) | 0 | 0/63 (0%) | 0 | 0/52 (0%) | 0 |
| Neurology | 2/56 (3.6%) | 2 | 2/64 (3.1%) | 2 | 1/61 (1.6%) | 1 | 0/12 (0%) | 0 | 1/66 (1.5%) | 1 | 3/63 (4.8%) | 4 | 1/52 (1.9%) | 1 |
| Psychiatric disorders | ||||||||||||||
| Confusion | 0/56 (0%) | 0 | 0/64 (0%) | 0 | 0/61 (0%) | 0 | 0/12 (0%) | 0 | 2/66 (3%) | 2 | 1/63 (1.6%) | 1 | 1/52 (1.9%) | 1 |
| Delusions | 0/56 (0%) | 0 | 0/64 (0%) | 0 | 0/61 (0%) | 0 | 0/12 (0%) | 0 | 2/66 (3%) | 2 | 0/63 (0%) | 0 | 0/52 (0%) | 0 |
| Hallucinations | 0/56 (0%) | 0 | 0/64 (0%) | 0 | 0/61 (0%) | 0 | 0/12 (0%) | 0 | 1/66 (1.5%) | 1 | 0/63 (0%) | 0 | 1/52 (1.9%) | 1 |
| Mood alteration-anxiety, agitation | 2/56 (3.6%) | 2 | 2/64 (3.1%) | 2 | 1/61 (1.6%) | 1 | 0/12 (0%) | 0 | 2/66 (3%) | 2 | 0/63 (0%) | 0 | 0/52 (0%) | 0 |
| Mood alteration-depression | 0/56 (0%) | 0 | 4/64 (6.3%) | 9 | 2/61 (3.3%) | 2 | 0/12 (0%) | 0 | 0/66 (0%) | 0 | 2/63 (3.2%) | 2 | 1/52 (1.9%) | 1 |
| Personality/behavioral | 0/56 (0%) | 0 | 1/64 (1.6%) | 2 | 1/61 (1.6%) | 2 | 0/12 (0%) | 0 | 2/66 (3%) | 2 | 0/63 (0%) | 0 | 1/52 (1.9%) | 1 |
| Renal and urinary disorders | ||||||||||||||
| Hematuria (in the absence of vaginal bleeding) | 2/56 (3.6%) | 2 | 1/64 (1.6%) | 1 | 1/61 (1.6%) | 1 | 0/12 (0%) | 0 | 0/66 (0%) | 0 | 1/63 (1.6%) | 1 | 0/52 (0%) | 0 |
| Dysuria | 1/56 (1.8%) | 1 | 2/64 (3.1%) | 2 | 0/61 (0%) | 0 | 0/12 (0%) | 0 | 1/66 (1.5%) | 1 | 0/63 (0%) | 0 | 0/52 (0%) | 0 |
| Incontinence | 0/56 (0%) | 0 | 0/64 (0%) | 0 | 0/61 (0%) | 0 | 0/12 (0%) | 0 | 1/66 (1.5%) | 1 | 0/63 (0%) | 0 | 0/52 (0%) | 0 |
| Proteinuria | 0/56 (0%) | 0 | 2/64 (3.1%) | 2 | 0/61 (0%) | 0 | 0/12 (0%) | 0 | 0/66 (0%) | 0 | 0/63 (0%) | 0 | 0/52 (0%) | 0 |
| Renal failure | 51/56 (91.1%) | 431 | 61/64 (95.3%) | 480 | 57/61 (93.4%) | 457 | 10/12 (83.3%) | 62 | 63/66 (95.5%) | 480 | 61/63 (96.8%) | 436 | 52/52 (100%) | 476 |
| Urinary frequency/urgency | 0/56 (0%) | 0 | 1/64 (1.6%) | 1 | 0/61 (0%) | 0 | 0/12 (0%) | 0 | 2/66 (3%) | 2 | 0/63 (0%) | 0 | 0/52 (0%) | 0 |
| Urinary retention | 0/56 (0%) | 0 | 0/64 (0%) | 0 | 0/61 (0%) | 0 | 0/12 (0%) | 0 | 0/66 (0%) | 0 | 1/63 (1.6%) | 1 | 0/52 (0%) | 0 |
| Renal/Genitourinary | 1/56 (1.8%) | 1 | 2/64 (3.1%) | 2 | 2/61 (3.3%) | 2 | 0/12 (0%) | 0 | 1/66 (1.5%) | 1 | 0/63 (0%) | 0 | 0/52 (0%) | 0 |
| Reproductive system and breast disorders | ||||||||||||||
| Vaginal bleeding | 0/56 (0%) | 0 | 1/64 (1.6%) | 1 | 0/61 (0%) | 0 | 0/12 (0%) | 0 | 0/66 (0%) | 0 | 0/63 (0%) | 0 | 0/52 (0%) | 0 |
| Irregular menses | 0/56 (0%) | 0 | 1/64 (1.6%) | 1 | 0/61 (0%) | 0 | 0/12 (0%) | 0 | 0/66 (0%) | 0 | 0/63 (0%) | 0 | 0/52 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||||||||||||
| Epistaxis | 2/56 (3.6%) | 3 | 1/64 (1.6%) | 1 | 0/61 (0%) | 0 | 0/12 (0%) | 0 | 4/66 (6.1%) | 4 | 1/63 (1.6%) | 2 | 0/52 (0%) | 0 |
| Adult respiratory distress syndrome (ARDS) | 0/56 (0%) | 0 | 0/64 (0%) | 0 | 2/61 (3.3%) | 2 | 0/12 (0%) | 0 | 0/66 (0%) | 0 | 0/63 (0%) | 0 | 0/52 (0%) | 0 |
| Apnea | 0/56 (0%) | 0 | 0/64 (0%) | 0 | 0/61 (0%) | 0 | 0/12 (0%) | 0 | 0/66 (0%) | 0 | 1/63 (1.6%) | 1 | 0/52 (0%) | 0 |
| Cough | 2/56 (3.6%) | 8 | 5/64 (7.8%) | 8 | 2/61 (3.3%) | 2 | 1/12 (8.3%) | 1 | 2/66 (3%) | 5 | 7/63 (11.1%) | 9 | 3/52 (5.8%) | 4 |
| Dyspnea (shortness of breath) | 0/56 (0%) | 0 | 3/64 (4.7%) | 3 | 2/61 (3.3%) | 2 | 0/12 (0%) | 0 | 2/66 (3%) | 2 | 1/63 (1.6%) | 1 | 2/52 (3.8%) | 3 |
| Hypoxia | 2/56 (3.6%) | 2 | 2/64 (3.1%) | 2 | 4/61 (6.6%) | 4 | 0/12 (0%) | 0 | 4/66 (6.1%) | 4 | 4/63 (6.3%) | 4 | 2/52 (3.8%) | 3 |
| Pleural effusion (non-malignant) | 0/56 (0%) | 0 | 1/64 (1.6%) | 1 | 6/61 (9.8%) | 8 | 0/12 (0%) | 0 | 0/66 (0%) | 0 | 0/63 (0%) | 0 | 1/52 (1.9%) | 1 |
| Pneumonitis/pulmonary infiltrates | 0/56 (0%) | 0 | 1/64 (1.6%) | 1 | 5/61 (8.2%) | 5 | 1/12 (8.3%) | 3 | 2/66 (3%) | 2 | 1/63 (1.6%) | 1 | 3/52 (5.8%) | 3 |
| Pneumothorax | 0/56 (0%) | 0 | 1/64 (1.6%) | 1 | 1/61 (1.6%) | 1 | 0/12 (0%) | 0 | 1/66 (1.5%) | 1 | 0/63 (0%) | 0 | 0/52 (0%) | 0 |
| Voice changes/stridor/larynx | 0/56 (0%) | 0 | 0/64 (0%) | 0 | 0/61 (0%) | 0 | 1/12 (8.3%) | 1 | 0/66 (0%) | 0 | 0/63 (0%) | 0 | 2/52 (3.8%) | 2 |
| Pulmonary | 1/56 (1.8%) | 1 | 1/64 (1.6%) | 1 | 1/61 (1.6%) | 1 | 1/12 (8.3%) | 1 | 2/66 (3%) | 2 | 1/63 (1.6%) | 1 | 1/52 (1.9%) | 1 |
| Allergic Rhinitis | 0/56 (0%) | 0 | 2/64 (3.1%) | 9 | 3/61 (4.9%) | 5 | 2/12 (16.7%) | 4 | 1/66 (1.5%) | 2 | 6/63 (9.5%) | 9 | 0/52 (0%) | 0 |
| Skin and subcutaneous tissue disorders | ||||||||||||||
| Alopecia | 0/56 (0%) | 0 | 3/64 (4.7%) | 8 | 1/61 (1.6%) | 1 | 0/12 (0%) | 0 | 3/66 (4.5%) | 9 | 1/63 (1.6%) | 1 | 1/52 (1.9%) | 1 |
| Dry skin | 0/56 (0%) | 0 | 1/64 (1.6%) | 1 | 0/61 (0%) | 0 | 0/12 (0%) | 0 | 0/66 (0%) | 0 | 0/63 (0%) | 0 | 0/52 (0%) | 0 |
| Erythema multiforme | 0/56 (0%) | 0 | 1/64 (1.6%) | 1 | 0/61 (0%) | 0 | 1/12 (8.3%) | 1 | 0/66 (0%) | 0 | 0/63 (0%) | 0 | 0/52 (0%) | 0 |
| Hand-foot skin reaction | 0/56 (0%) | 0 | 0/64 (0%) | 0 | 0/61 (0%) | 0 | 0/12 (0%) | 0 | 2/66 (3%) | 2 | 0/63 (0%) | 0 | 1/52 (1.9%) | 1 |
| Pruritus | 0/56 (0%) | 0 | 0/64 (0%) | 0 | 2/61 (3.3%) | 2 | 0/12 (0%) | 0 | 1/66 (1.5%) | 1 | 0/63 (0%) | 0 | 0/52 (0%) | 0 |
| Rash/desquamation | 2/56 (3.6%) | 2 | 3/64 (4.7%) | 6 | 4/61 (6.6%) | 6 | 1/12 (8.3%) | 2 | 5/66 (7.6%) | 11 | 5/63 (7.9%) | 5 | 2/52 (3.8%) | 3 |
| Urticaria | 0/56 (0%) | 0 | 0/64 (0%) | 0 | 0/61 (0%) | 0 | 0/12 (0%) | 0 | 1/66 (1.5%) | 1 | 0/63 (0%) | 0 | 0/52 (0%) | 0 |
| Dermatology/Skin | 1/56 (1.8%) | 1 | 2/64 (3.1%) | 2 | 7/61 (11.5%) | 10 | 0/12 (0%) | 0 | 1/66 (1.5%) | 1 | 2/63 (3.2%) | 4 | 2/52 (3.8%) | 2 |
| Petechiae/purpura (hemorrhage/bleeding into skin or mucosa) | 0/56 (0%) | 0 | 1/64 (1.6%) | 1 | 1/61 (1.6%) | 1 | 0/12 (0%) | 0 | 0/66 (0%) | 0 | 0/63 (0%) | 0 | 0/52 (0%) | 0 |
| Vascular disorders | ||||||||||||||
| Hypertension | 1/56 (1.8%) | 2 | 4/64 (6.3%) | 4 | 6/61 (9.8%) | 7 | 0/12 (0%) | 0 | 7/66 (10.6%) | 7 | 5/63 (7.9%) | 5 | 9/52 (17.3%) | 11 |
| Hypotension | 1/56 (1.8%) | 1 | 2/64 (3.1%) | 2 | 4/61 (6.6%) | 5 | 0/12 (0%) | 0 | 4/66 (6.1%) | 4 | 2/63 (3.2%) | 2 | 2/52 (3.8%) | 2 |
| Thrombosis/embolism | 2/56 (3.6%) | 2 | 7/64 (10.9%) | 7 | 4/61 (6.6%) | 4 | 0/12 (0%) | 0 | 6/66 (9.1%) | 6 | 5/63 (7.9%) | 7 | 6/52 (11.5%) | 6 |
| Flushing | 1/56 (1.8%) | 1 | 0/64 (0%) | 0 | 0/61 (0%) | 0 | 0/12 (0%) | 0 | 2/66 (3%) | 2 | 0/63 (0%) | 0 | 0/52 (0%) | 0 |
| Hemorrhage/bleeding with grade 3 or 4 thrombocytopenia | 0/56 (0%) | 0 | 3/64 (4.7%) | 3 | 0/61 (0%) | 0 | 0/12 (0%) | 0 | 1/66 (1.5%) | 1 | 0/63 (0%) | 0 | 0/52 (0%) | 0 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Must obtain prior Sponsor approval.
Results Point of Contact
| Name/Title | Results Reporting Coordinator |
|---|---|
| Organization | Children's Oncology Group |
| Phone | 626-447-0064 |
| resultsreportingcoordinator@childrensoncologygroup.org |
Responsible Party:
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT00004228
Other Study ID Numbers:
- A5971
- CCG-59701
- CCG-59701C
- CCG-A5971
- POG-A5971
- CDR0000067470
First Posted:
Jan 27, 2003
Last Update Posted:
Aug 6, 2019
Last Verified:
Nov 1, 2016