Combination Chemotherapy and Radiation Therapy in Treating Patients With Acute Lymphoblastic Leukemia That Has Relapsed in the CNS or Testes
Study Details
Study Description
Brief Summary
RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. Giving combination chemotherapy together with radiation therapy may kill more cancer cells.
PURPOSE: This clinical trial is studying how well giving chemotherapy together with radiation therapy works in treating patients with acute lymphoblastic leukemia that has relapsed in the CNS and/or testes.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
Detailed Description
OBJECTIVES:
Primary
-
Determine the efficacy of intensified systemic chemotherapy with reduced-dose CNS radiotherapy in patients with acute lymphoblastic leukemia and late isolated CNS relapse.
-
Determine the efficacy of intensive systemic chemotherapy without testicular radiotherapy in patients with acute lymphoblastic leukemia and late isolated testicular relapse.
-
Determine the toxicity of these regimens in these patients.
Secondary
-
Determine whether bone marrow involvement is present at the time of extramedullary relapse in patients treated with these regimens.
-
Correlate pretreatment minimal residual disease with outcomes in patients treated with these regimens.
-
Correlate the role of host gene polymorphisms with toxicity of these regimens and incidence and outcome in these patients.
-
Determine the neuropsychological sequelae associated with isolated CNS relapse and these treatment regimens in these patients.
OUTLINE: This is a pilot, multicenter study. All patients receive common induction, consolidation, re-induction, and intensification chemotherapy. Patients are stratified to maintenance therapy according to site of extramedullary relapse (CNS vs testicular).
- Induction therapy (weeks 1-4): Patients receive vincristine IV on days 1, 8, 15, and 22; oral dexamethasone twice daily on days 1-28; daunorubicin* IV over 15 minutes on days 1, 8, and 15; and intrathecal triple therapy** (ITT) comprising methotrexate, hydrocortisone, and cytarabine on days 1, 8, 15, and 22.
NOTE: *The total dose of anthracyclines on this study is capped at 450 mg/m2. Once this dose is reached, all subsequent doses of daunorubicin are omitted.
NOTE: **Patients with isolated testicular relapse receive ITT on day 1 only.
In addition to the above, patients with isolated testicular relapse also receive high-dose methotrexate IV continuously over 24 hours on day -14. Patients with clinical signs of disease at the end of induction undergo testicular biopsy.
Patients with CNS disease who do not achieve CNS remission after induction therapy receive additional ITT as above on days 29 and 36.
- Consolidation therapy (weeks 5-10): Patients receive high-dose cytarabine IV over 3 hours twice daily on days 1-2 and 22-23 and pegaspargase intramuscularly (IM) on days 2 and 23. Patients also receive filgrastim (G-CSF) subcutaneously (SC) beginning on days 3 and 24 and continuing until blood counts recover.
Patients with isolated testicular relapse with positive biopsy results at the end of induction undergo testicular radiotherapy once daily for a total of 12 fractions during consolidation therapy.
- Intensification I (weeks 11-22): Patients receive high-dose methotrexate with leucovorin calcium rescue IV over 24 hours on days 1, 22, 43, and 64 and oral mercaptopurine once daily on days 2-6, 23-27, 44-48, and 65-69. Patients also receive etoposide IV over 1 hour and cyclophosphamide IV over 15-30 minutes on days 8, 29, 50, and 71. Patients receive ITT* on days 15, 36, 57, and 78.
NOTE: *Patients with isolated testicular relapse receive ITT on days 36 and 78 only.
-
Reinduction therapy (weeks 23-26): Patients receive vincristine IV on days 1, 8, 15, and 22; oral dexamethasone twice daily on days 1-7 and 15-21, and daunorubicin IV over 15 minutes on days 1, 8, and 15.
-
Intensification II (weeks 27-50): Patients receive high-dose cytarabine IV over 3 hours twice daily on days 1-2, 43-44, 85-86, and 127-128; pegaspargase IM on days 2, 44, 86, and 128; ITT* on days 22, 64, 106, and 148; high-dose methotrexate IV continuously over 24 hours on days 29, 71, 113, and 155; oral mercaptopurine on days 30-34, 72-76, 114-118, and 156-160; and etoposide IV over 1 hour and cyclophosphamide IV over 15-30 minutes on days 36, 78, 120, and 162. Patients also receive G-CSF SC beginning on days 3, 45, 87, and 129 and continuing until blood counts recover.
NOTE: *Patients with isolated testicular relapse receive ITT on days 22 and 106 only.
- Chemotherapy and radiotherapy (weeks 51-54): Patients receive oral dexamethasone twice daily on days 1-7 and 15-21, vincristine IV on days 1, 8, and 15, and pegaspargase IM on days 1 and 15.
Patients with isolated CNS relapse also undergo cranial radiotherapy once daily, 5 days a week, for a total of 12 fractions.
-
Maintenance therapy for isolated CNS relapse: (weeks 55-104): Patients receive dexamethasone PO orIV twice daily on days 1-5; oral mercaptopurine once daily on days 1-42; methotrexate IM on days 1, 8, 15, 22, 29, and 36; and vincristine IV and cyclophosphamide IV over 1 hour on days 43, 50, 57, and 64. Treatment repeats every 10 weeks for 5 courses.
-
Maintenance therapy for isolated testicular relapse:
-
(Weeks 55-74): Patients receive ITT on day 1 and dexamethasone, mercaptopurine, methotrexate, vincristine, and cyclophosphamide as in maintenance therapy for isolated CNS relapse. Treatment repeats every 10 weeks for 2 courses.
-
(Weeks 75-106): Patients receive vincristine IV on day 1; dexamethasone orally or IV on days 1-5; oral mercaptopurine on days 1-28; and methotrexate IM on days 1, 8, 15, and 22. Treatment repeats every 28 days for 8 courses. Patients also receive ITT on day 1 every 12 weeks for 3 doses.
Patients with combined testicular and CNS relapse receive high-dose methotrexate IV continuously over 24 hours on day -14 in addition to the same chemotherapy and radiotherapy administered during the induction, consolidation, intensification I, reinduction, intensification II, and maintenance phases of therapy as isolated CNS relapse patients.
All patients undergo neuropsychological assessment within 3 months after completion of induction therapy (before cranial radiotherapy) and at 2 years after completion of treatment.
Patients are followed for survival.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: CNS Patients-Treatment (combination chemotherapy) All patients receive common induction (vincristine sulfate, dexamethasone, daunorubicin hydrochloride & intrathecal triple therapy (ITT: MTX, therapeutic hydrocortisone and cytarabine)), consolidation (cytarabine, pegaspargase, filgrastim, re-induction (vincristine, dexamethasone, daunorubicin), and intensification chemotherapy (MTX, leucovorin calcium, mercaptopurine, etoposide, cyclophosphamide & ITT. |
Biological: filgrastim
given subcutaneously (SC)
Other Names:
Drug: cyclophosphamide
IV over 15-30 minutes
Other Names:
Drug: cytarabine
IV over 3 hours twice daily
Other Names:
Drug: daunorubicin hydrochloride
IV over 15 minutes
Other Names:
Drug: dexamethasone
oral twice daily
Other Names:
Drug: etoposide
IV over 1 hour
Other Names:
Drug: leucovorin calcium
rescue IV over 24 hours
Other Names:
Drug: mercaptopurine
oral
Other Names:
Drug: methotrexate
intramuscularly (IM)
Other Names:
Drug: pegaspargase
intramuscularly (IM)
Other Names:
Drug: therapeutic hydrocortisone
Drug: vincristine sulfate
given IV
Other Names:
Radiation: radiation therapy
Patients with isolated testicular relapse will start Induction with a single dose of high-dose methotrexate (HDMTX) and will not receive either testicular or cranial radiation. Patients with isolated CNS relapse will NOT receive the initial dose of HDMTX prior to Induction, but will receive 1200 cGy of cranial radiation after completing the initial 12 months of intensive systemic chemotherapy.
|
Experimental: Testicular Relapse Patients (Combination chemotherapy) All patients receive common induction (vincristine sulfate, dexamethasone, daunorubicin hydrochloride & intrathecal triple therapy (ITT: MTX, therapeutic hydrocortisone and cytarabine)), consolidation (cytarabine, pegaspargase, filgrastim, testicular radiation therapy, re-induction (vincristine, dexamethasone, daunorubicin), and intensification chemotherapy (MTX, leucovorin calcium, mercaptopurine, etoposide, cyclophosphamide & ITT. |
Biological: filgrastim
given subcutaneously (SC)
Other Names:
Drug: cyclophosphamide
IV over 15-30 minutes
Other Names:
Drug: cytarabine
IV over 3 hours twice daily
Other Names:
Drug: daunorubicin hydrochloride
IV over 15 minutes
Other Names:
Drug: dexamethasone
oral twice daily
Other Names:
Drug: etoposide
IV over 1 hour
Other Names:
Drug: leucovorin calcium
rescue IV over 24 hours
Other Names:
Drug: mercaptopurine
oral
Other Names:
Drug: methotrexate
intramuscularly (IM)
Other Names:
Drug: pegaspargase
intramuscularly (IM)
Other Names:
Drug: therapeutic hydrocortisone
Drug: vincristine sulfate
given IV
Other Names:
Radiation: radiation therapy
Patients with isolated testicular relapse will start Induction with a single dose of high-dose methotrexate (HDMTX) and will not receive either testicular or cranial radiation. Patients with isolated CNS relapse will NOT receive the initial dose of HDMTX prior to Induction, but will receive 1200 cGy of cranial radiation after completing the initial 12 months of intensive systemic chemotherapy.
|
Outcome Measures
Primary Outcome Measures
- Event-free Survival [3 years]
Monitoring of efficacy results will be performed in comparison with historical results.
Eligibility Criteria
Criteria
DISEASE CHARACTERISTICS:
-
Diagnosis of acute lymphoblastic leukemia (ALL)
-
B-precursor lineage (T-precursor lineage closed to accrual as of 05/20/10)
-
In first bone marrow remission (M1 by morphology) AND duration of first complete remission ≥ 18 months from time of initial diagnosis
-
First isolated CNS and/or testicular relapse
-
Isolated CNS relapse, as defined by 1 of the following:
-
WBC ≥ 5/mm^3 in cerebrospinal fluid (CSF) with blasts present on cytospin
-
Any number of WBC in CSF with immunophenotypic proof of leukemic relapse, defined by the following:
-
Identifiable blasts AND 1 of the following:
-
B-lineage (TdT OR CD-10-positive on 2 consecutive CSF samples obtained 4 weeks apart)
-
T-lineage (TdT AND CD-7 OR TdT positivity alone on 2 consecutive CSF samples obtained 4 weeks apart) (Closed to accrual as of 05/20/10)
-
Isolated testicular relapse, defined as biopsy proven testicular involvement
-
No Down syndrome
-
No T-cell ALL or T-cell non-Hodgkin lymphoma
-
No known optic nerve and/or retinal involvement
PATIENT CHARACTERISTICS:
Age
- 18 months to 29 years at relapse
Performance status
-
Karnofsky 30-100% (for patients > 16 years of age) OR
-
Lansky 30-100% (for patients ≤ 16 years of age)
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
-
Creatinine adjusted according to age as follows:
-
No greater than 0.4 mg/dL (≤ 5 months)
-
No greater than 0.5 mg/dL (6 months -11 months)
-
No greater than 0.6 mg/dL (1 year-23 months)
-
No greater than 0.8 mg/dL (2 years-5 years)
-
No greater than 1.0 mg/dL (6 years-9 years)
-
No greater than 1.2 mg/dL (10 years-12 years)
-
No greater than 1.4 mg/dL (13 years and over [female])
-
No greater than 1.5 mg/dL (13 years to 15 years [male])
-
No greater than 1.7 mg/dL (16 years and over [male]) OR
-
Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min
Cardiovascular
-
Shortening fraction ≥ 27% by echocardiogram OR
-
Ejection fraction ≥ 50% by MUGA
Other
- Not pregnant or nursing
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No prior bone marrow transplantation
Chemotherapy
- Prior total anthracycline dosage ≤ 360 mg/m^2
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Other
- No prior systemic therapy for concurrent extramedullary relapse
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | UAB Comprehensive Cancer Center | Birmingham | Alabama | United States | 35294 |
2 | Phoenix Children's Hospital | Phoenix | Arizona | United States | 85016-7710 |
3 | Arizona Cancer Center at University of Arizona Health Sciences Center | Tucson | Arizona | United States | 85724-5024 |
4 | Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | Little Rock | Arkansas | United States | 72205 |
5 | Southern California Permanente Medical Group | Downey | California | United States | 90027 |
6 | City of Hope Comprehensive Cancer Center | Duarte | California | United States | 91010-3000 |
7 | Loma Linda University Cancer Institute at Loma Linda University Medical Center | Loma Linda | California | United States | 92354 |
8 | Jonathan Jaques Children's Cancer Center at Miller Children's Hospital | Long Beach | California | United States | 90801 |
9 | Childrens Hospital Los Angeles | Los Angeles | California | United States | 90027 |
10 | Jonsson Comprehensive Cancer Center at UCLA | Los Angeles | California | United States | 90095-1781 |
11 | Children's Hospital Central California | Madera | California | United States | 93638-8762 |
12 | Children's Hospital and Research Center Oakland | Oakland | California | United States | 94609 |
13 | Children's Hospital of Orange County | Orange | California | United States | 92868 |
14 | Lucile Packard Children's Hospital at Stanford University Medical Center | Palo Alto | California | United States | 95798 |
15 | Sutter Cancer Center | Sacramento | California | United States | 95816 |
16 | Kaiser Permanente Medical Center - Oakland | Sacramento | California | United States | 95825 |
17 | UCSF Helen Diller Family Comprehensive Cancer Center | San Francisco | California | United States | 94115 |
18 | Children's Hospital Center for Cancer and Blood Disorders | Aurora | Colorado | United States | 80045 |
19 | Presbyterian - St. Luke's Medical Center | Denver | Colorado | United States | 80218 |
20 | Connecticut Children's Medical Center | Hartford | Connecticut | United States | 06106 |
21 | Alfred I. duPont Hospital for Children | Wilmington | Delaware | United States | 19803 |
22 | Children's National Medical Center | Washington | District of Columbia | United States | 20010-2970 |
23 | Broward General Medical Center Cancer Center | Fort Lauderdale | Florida | United States | 33316 |
24 | Lee Cancer Care of Lee Memorial Health System | Fort Myers | Florida | United States | 33901 |
25 | University of Florida Shands Cancer Center | Gainesville | Florida | United States | 32610-0232 |
26 | Memorial Cancer Institute at Memorial Regional Hospital | Hollywood | Florida | United States | 33021 |
27 | Nemours Children's Clinic | Jacksonville | Florida | United States | 32207 |
28 | University of Miami Sylvester Comprehensive Cancer Center - Miami | Miami | Florida | United States | 33136 |
29 | Miami Children's Hospital | Miami | Florida | United States | 33155 |
30 | Baptist-South Miami Regional Cancer Program | Miami | Florida | United States | 33176 |
31 | Florida Hospital Cancer Institute at Florida Hospital Orlando | Orlando | Florida | United States | 32803-1273 |
32 | M.D. Anderson Cancer Center at Orlando | Orlando | Florida | United States | 32806 |
33 | Nemours Children's Clinic - Orlando | Orlando | Florida | United States | 32806 |
34 | Sacred Heart Cancer Center at Sacred Heart Hospital | Pensacola | Florida | United States | 32504 |
35 | All Children's Hospital | Saint Petersburg | Florida | United States | 33701 |
36 | St. Joseph's Cancer Institute at St. Joseph's Hospital | Tampa | Florida | United States | 33607 |
37 | Kaplan Cancer Center at St. Mary's Medical Center | West Palm Beach | Florida | United States | 33407 |
38 | AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus | Atlanta | Georgia | United States | 30322 |
39 | Cancer Research Center of Hawaii | Honolulu | Hawaii | United States | 96813 |
40 | Mountain States Tumor Institute at St. Luke's Regional Medical Center | Boise | Idaho | United States | 83712-6297 |
41 | University of Illinois Cancer Center | Chicago | Illinois | United States | 60612-7243 |
42 | Cardinal Bernardin Cancer Center at Loyola University Medical Center | Maywood | Illinois | United States | 60153 |
43 | Keyser Family Cancer Center at Advocate Hope Children's Hospital | Oak Lawn | Illinois | United States | 60453 |
44 | Advocate Lutheran General Cancer Care Center | Park Ridge | Illinois | United States | 60068-1174 |
45 | Simmons Cooper Cancer Institute | Springfield | Illinois | United States | 62794-9677 |
46 | Indiana University Melvin and Bren Simon Cancer Center | Indianapolis | Indiana | United States | 46202-5289 |
47 | St. Vincent Indianapolis Hospital | Indianapolis | Indiana | United States | 46260 |
48 | Blank Children's Hospital | Des Moines | Iowa | United States | 50309 |
49 | Holden Comprehensive Cancer Center at University of Iowa | Iowa City | Iowa | United States | 52242-1002 |
50 | Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center | Kansas City | Kansas | United States | 66160-7357 |
51 | Lucille P. Markey Cancer Center at University of Kentucky | Lexington | Kentucky | United States | 40536-0093 |
52 | Kosair Children's Hospital | Louisville | Kentucky | United States | 40232 |
53 | CancerCare of Maine at Eastern Maine Medical Center | Bangor | Maine | United States | 04401 |
54 | Alvin and Lois Lapidus Cancer Institute at Sinai Hospital | Baltimore | Maryland | United States | 21215 |
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 | 48109-0286 |
57 | Barbara Ann Karmanos Cancer Institute | Detroit | Michigan | United States | 48201-1379 |
58 | Hurley Medical Center | Flint | Michigan | United States | 48503 |
59 | Butterworth Hospital at Spectrum Health | 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 | 49007-5381 |
62 | Breslin Cancer Center at Ingham Regional Medical Center | Lansing | Michigan | United States | 48910 |
63 | Children's Hospitals and Clinics of Minnesota - Minneapolis | Minneapolis | Minnesota | United States | 55404 |
64 | Mayo Clinic Cancer Center | Rochester | Minnesota | United States | 55905 |
65 | University of Mississippi Cancer Clinic | Jackson | Mississippi | United States | 39216-4505 |
66 | Ellis Fischel Cancer Center at University of Missouri - Columbia | Columbia | Missouri | United States | 65203 |
67 | Children's Mercy Hospital | Kansas City | Missouri | United States | 64108 |
68 | CCOP - Nevada Cancer Research Foundation | Las Vegas | Nevada | United States | 89109-2306 |
69 | Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | United States | 03756-0002 |
70 | Hackensack University Medical Center Cancer Center | Hackensack | New Jersey | United States | 07601 |
71 | Overlook Hospital | Morristown | New Jersey | United States | 07962 |
72 | Saint Peter's University Hospital | New Brunswick | New Jersey | United States | 08901 |
73 | Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School | New Brunswick | New Jersey | United States | 08903 |
74 | Newark Beth Israel Medical Center | Newark | New Jersey | United States | 07112 |
75 | St. Joseph's Hospital and Medical Center | Paterson | New Jersey | United States | 07503 |
76 | University of New Mexico Cancer Center | Albuquerque | New Mexico | United States | 87131-5636 |
77 | Albert Einstein Cancer Center at Albert Einstein College of Medicine | Bronx | New York | United States | 10461 |
78 | Brooklyn Hospital Center | Brooklyn | New York | United States | 11201-5493 |
79 | Maimonides Cancer Center at Maimonides Medical Center | Brooklyn | New York | United States | 11219 |
80 | Roswell Park Cancer Institute | Buffalo | New York | United States | 14263-0001 |
81 | Winthrop University Hospital | Mineola | New York | United States | 11501 |
82 | Schneider Children's Hospital | New Hyde Park | New York | United States | 11040 |
83 | NYU Cancer Institute at New York University Medical Center | New York | New York | United States | 10016 |
84 | Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center | New York | New York | United States | 10032 |
85 | James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester | New York | United States | 14642 |
86 | Stony Brook University Cancer Center | Stony Brook | New York | United States | 11794-9446 |
87 | SUNY Upstate Medical University Hospital | Syracuse | New York | United States | 13210 |
88 | New York Medical College | Valhalla | New York | United States | 10595 |
89 | Blumenthal Cancer Center at Carolinas Medical Center | Charlotte | North Carolina | United States | 28232-2861 |
90 | Presbyterian Cancer Center at Presbyterian Hospital | Charlotte | North Carolina | United States | 28233-3549 |
91 | Duke Comprehensive Cancer Center | Durham | North Carolina | United States | 27710 |
92 | Wake Forest University Comprehensive Cancer Center | Winston-Salem | North Carolina | United States | 27157-1096 |
93 | CCOP - MeritCare Hospital | Fargo | North Dakota | United States | 58122 |
94 | Akron Children's Hospital | Akron | Ohio | United States | 44308-1062 |
95 | Rainbow Babies and Children's Hospital | Cleveland | Ohio | United States | 44106-5000 |
96 | Cleveland Clinic Taussig Cancer Center | Cleveland | Ohio | United States | 44195 |
97 | Nationwide Children's Hospital | Columbus | Ohio | United States | 43205-2696 |
98 | Dayton Children's - Dayton | Dayton | Ohio | United States | 45404-1815 |
99 | Medical University of Ohio Cancer Center | Toledo | Ohio | United States | 43614 |
100 | Tod Children's Hospital | Youngstown | Ohio | United States | 44501 |
101 | Oklahoma University Cancer Institute | Oklahoma City | Oklahoma | United States | 73104 |
102 | Legacy Emanuel Hospital and Health Center and Children's Hospital | Portland | Oregon | United States | 97227 |
103 | Knight Cancer Institute at Oregon Health and Science University | Portland | Oregon | United States | 97239-3098 |
104 | Lehigh Valley Hospital - Muhlenberg | Bethlehem | Pennsylvania | United States | 18017 |
105 | Geisinger Cancer Institute at Geisinger Health | Danville | Pennsylvania | United States | 17822-0001 |
106 | Penn State Children's Hospital | Hershey | Pennsylvania | United States | 17033-0850 |
107 | Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | United States | 19104-9786 |
108 | St. Christopher's Hospital for Children | Philadelphia | Pennsylvania | United States | 19134-1095 |
109 | Children's Hospital of Pittsburgh of UPMC | Pittsburgh | Pennsylvania | United States | 15213 |
110 | Rhode Island Hospital Comprehensive Cancer Center | Providence | Rhode Island | United States | 02903 |
111 | Hollings Cancer Center at Medical University of South Carolina | Charleston | South Carolina | United States | 29425 |
112 | Greenville Hospital Cancer Center | Greenville | South Carolina | United States | 29605 |
113 | Sanford Cancer Center at Sanford USD Medical Center | Sioux Falls | South Dakota | United States | 57117-5039 |
114 | T.C. Thompson Children's Hospital | Chattanooga | Tennessee | United States | 37403 |
115 | East Tennessee Children's Hospital | Knoxville | Tennessee | United States | 37901 |
116 | Vanderbilt-Ingram Cancer Center | Nashville | Tennessee | United States | 37232-6838 |
117 | Texas Tech University Health Sciences Center School of Medicine - Amarillo | Amarillo | Texas | United States | 79106 |
118 | Driscoll Children's Hospital | Corpus Christi | Texas | United States | 78411 |
119 | Medical City Dallas Hospital | Dallas | Texas | United States | 75230 |
120 | Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas | Dallas | Texas | United States | 75390 |
121 | Cook Children's Medical Center - Fort Worth | Fort Worth | Texas | United States | 76104 |
122 | Baylor University Medical Center - Houston | Houston | Texas | United States | 77030-2399 |
123 | University of Texas Health Science Center at San Antonio | San Antonio | Texas | United States | 78207 |
124 | Methodist Children's Hospital of South Texas | San Antonio | Texas | United States | 78229-3993 |
125 | Primary Children's Medical Center | Salt Lake City | Utah | United States | 84113-1100 |
126 | Fletcher Allen Health Care - University Health Center Campus | Burlington | Vermont | United States | 05401 |
127 | Inova Fairfax Hospital | Falls Church | Virginia | United States | 22042-3300 |
128 | Carilion Medical Center for Children at Roanoke Community Hospital | Roanoke | Virginia | United States | 24014 |
129 | Providence Cancer Center at Sacred Heart Medical Center | Spokane | Washington | United States | 99220-2555 |
130 | West Virginia University Health Sciences Center - Charleston | Charleston | West Virginia | United States | 25302 |
131 | Mary Babb Randolph Cancer Center at West Virginia University Hospitals | Morgantown | West Virginia | United States | 26506 |
132 | St. Vincent Hospital Regional Cancer Center | Green Bay | Wisconsin | United States | 54307-3508 |
133 | Gundersen Lutheran Center for Cancer and Blood | La Crosse | Wisconsin | United States | 54601 |
134 | Marshfield Clinic - Marshfield Center | Marshfield | Wisconsin | United States | 54449 |
135 | Midwest Children's Cancer Center at Children's Hospital of Wisconsin | Milwaukee | Wisconsin | United States | 53226 |
136 | Princess Margaret Hospital for Children | Perth | Western Australia | Australia | 6001 |
137 | University of Alberta Hospital | Edmonton | Alberta | Canada | T6G 1Z2 |
138 | Children's & Women's Hospital of British Columbia | Vancouver | British Columbia | Canada | V6H 3V4 |
139 | CancerCare Manitoba | Winnipeg | Manitoba | Canada | R3E 0V9 |
140 | Janeway Children's Health and Rehabilitation Centre | St. John's | Newfoundland and Labrador | Canada | A1B 3V6 |
141 | IWK Health Centre | Halifax | Nova Scotia | Canada | B3J 3G9 |
142 | McMaster Children's Hospital at Hamilton Health Sciences | Hamilton | Ontario | Canada | L8N 3Z5 |
143 | Cancer Centre of Southeastern Ontario at Kingston General Hospital | Kingston | Ontario | Canada | K7L 2V7 |
144 | Children's Hospital of Eastern Ontario | Ottawa | Ontario | Canada | K1H 8L1 |
145 | Hopital Sainte Justine | Montreal | Quebec | Canada | H3T 1C5 |
146 | Allan Blair Cancer Centre at Pasqua Hospital | Regina | Saskatchewan | Canada | S4T 7T1 |
147 | Saskatoon Cancer Centre at the University of Saskatchewan | Saskatoon | Saskatchewan | Canada | S7N 4H4 |
148 | Centre Hospitalier Universitaire de Quebec | Quebec | Canada | G1V 4G2 | |
149 | Starship Children's Health | Auckland | New Zealand | 1 | |
150 | Christchurch Hospital | Christchurch | New Zealand | 8140 | |
151 | Swiss Pediatric Oncology Group Bern | Bern | Switzerland | 3010 | |
152 | Swiss Pediatric Oncology Group Geneva | Geneva | Switzerland | 1205 | |
153 | Swiss Pediatric Oncology Group Lausanne | Lausanne | Switzerland | 1011 |
Sponsors and Collaborators
- Children's Oncology Group
- National Cancer Institute (NCI)
Investigators
- Study Chair: Julio C. Barredo, MD, University of Miami Miller School of Medicine-Sylvester Cancer Center
- Study Chair: Caroline A. Hastings, MD, UCSF Benioff Children's Hospital Oakland
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- AALL02P2
- COG-AALL02P2
- NCI-2011-01623
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | CNS Patients - Treatment (Combination Chemotherapy) | Testicular Relapse Patients (Combination Chemotherapy) |
---|---|---|
Arm/Group Description | All patients receive common induction (vincristine sulfate, dexamethasone, daunorubicin hydrochloride & intrathecal triple therapy (ITT: methotrexate, therapeutic hydrocortisone and cytarabine)), consolidation (cytarabine, pegaspargase, filgrastim, re-induction (vincristine, dexamethasone, daunorubicin), and intensification chemotherapy (methotrexate, leucovorin calcium, mercaptopurine, etoposide, cyclophosphamide & ITT. | All patients receive common induction (vincristine sulfate, dexamethasone, daunorubicin hydrochloride & intrathecal triple therapy (ITT: methotrexate, therapeutic hydrocortisone and cytarabine)), consolidation (cytarabine, pegaspargase, filgrastim, testicular radiation therapy, re-induction (vincristine, dexamethasone, daunorubicin), and intensification chemotherapy (methotrexate, leucovorin calcium, mercaptopurine, etoposide, cyclophosphamide & ITT. |
Period Title: Overall Study | ||
STARTED | 126 | 42 |
COMPLETED | 63 | 27 |
NOT COMPLETED | 63 | 15 |
Baseline Characteristics
Arm/Group Title | CNS Patients - Treatment (Combination Chemotherapy) | Testicular Relapse Patients (Combination Chemotherapy) | Total |
---|---|---|---|
Arm/Group Description | All patients receive common induction (vincristine sulfate, dexamethasone, daunorubicin hydrochloride & intrathecal triple therapy (ITT: methotrexate, therapeutic hydrocortisone and cytarabine)), consolidation (cytarabine, pegaspargase, filgrastim, re-induction (vincristine, dexamethasone, daunorubicin), and intensification chemotherapy (methotrexate, leucovorin calcium, mercaptopurine, etoposide, cyclophosphamide & ITT. | All patients receive common induction (vincristine sulfate, dexamethasone, daunorubicin hydrochloride & intrathecal triple therapy (ITT: methotrexate, therapeutic hydrocortisone and cytarabine)), consolidation (cytarabine, pegaspargase, filgrastim, testicular radiation therapy, re-induction (vincristine, dexamethasone, daunorubicin), and intensification chemotherapy (methotrexate, leucovorin calcium, mercaptopurine, etoposide, cyclophosphamide & ITT. | Total of all reporting groups |
Overall Participants | 124 | 42 | 166 |
Age (Count of Participants) | |||
<=18 years |
118
95.2%
|
42
100%
|
160
96.4%
|
Between 18 and 65 years |
6
4.8%
|
0
0%
|
6
3.6%
|
>=65 years |
0
0%
|
0
0%
|
0
0%
|
Age (years) [Mean (Standard Deviation) ] | |||
Mean (Standard Deviation) [years] |
8.2
(4.8)
|
9.2
(3.2)
|
8.5
(4.2)
|
Sex: Female, Male (Count of Participants) | |||
Female |
36
29%
|
0
0%
|
36
21.7%
|
Male |
88
71%
|
42
100%
|
130
78.3%
|
Ethnicity (NIH/OMB) (Count of Participants) | |||
Hispanic or Latino |
33
26.6%
|
10
23.8%
|
43
25.9%
|
Not Hispanic or Latino |
87
70.2%
|
30
71.4%
|
117
70.5%
|
Unknown or Not Reported |
4
3.2%
|
2
4.8%
|
6
3.6%
|
Race (NIH/OMB) (Count of Participants) | |||
American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
Asian |
8
6.5%
|
1
2.4%
|
9
5.4%
|
Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
Black or African American |
10
8.1%
|
2
4.8%
|
12
7.2%
|
White |
91
73.4%
|
33
78.6%
|
124
74.7%
|
More than one race |
0
0%
|
0
0%
|
0
0%
|
Unknown or Not Reported |
15
12.1%
|
6
14.3%
|
21
12.7%
|
Outcome Measures
Title | Event-free Survival |
---|---|
Description | Monitoring of efficacy results will be performed in comparison with historical results. |
Time Frame | 3 years |
Outcome Measure Data
Analysis Population Description |
---|
The CNS-treatment cohort includes 126 patients with 120 CNS pre-B, 2 CNS+ITR pre-B and 4 T-AL. The primary analysis was restricted to CNS pre-B and ITR pre-B patients, respectively. Both CNS+ITR and T-ALL patients had to be excluded from the primary analysis. That is how we came to 120 in the CNS-treatment cohort for outcome analysis. |
Arm/Group Title | CNS Patients - Treatment (Combination Chemotherapy) | Testicular Relapse Patients (Combination Chemotherapy) |
---|---|---|
Arm/Group Description | All patients receive common induction (vincristine sulfate, dexamethasone, daunorubicin hydrochloride & intrathecal triple therapy (ITT: methotrexate, therapeutic hydrocortisone and cytarabine)), consolidation (cytarabine, pegaspargase, filgrastim, re-induction (vincristine, dexamethasone, daunorubicin), and intensification chemotherapy (methotrexate, leucovorin calcium, mercaptopurine, etoposide, cyclophosphamide & ITT. | All patients receive common induction (vincristine sulfate, dexamethasone, daunorubicin hydrochloride & intrathecal triple therapy (ITT: methotrexate, therapeutic hydrocortisone and cytarabine)), consolidation (cytarabine, pegaspargase, filgrastim, testicular radiation therapy, re-induction (vincristine, dexamethasone, daunorubicin), and intensification chemotherapy (methotrexate, leucovorin calcium, mercaptopurine, etoposide, cyclophosphamide & ITT. |
Measure Participants | 120 | 40 |
Number [percentage of participants] |
64.9
52.3%
|
70
166.7%
|
Adverse Events
Time Frame | ||||
---|---|---|---|---|
Adverse Event Reporting Description | SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting. | |||
Arm/Group Title | CNS Patients - Treatment (Combination Chemotherapy) | Testicular Relapse Patients (Combination Chemotherapy) | ||
Arm/Group Description | All patients receive common induction (vincristine sulfate, dexamethasone, daunorubicin hydrochloride & intrathecal triple therapy (ITT: methotrexate, therapeutic hydrocortisone and cytarabine)), consolidation (cytarabine, pegaspargase, filgrastim, re-induction (vincristine, dexamethasone, daunorubicin), and intensification chemotherapy (methotrexate, leucovorin calcium, mercaptopurine, etoposide, cyclophosphamide & ITT. | All patients receive common induction (vincristine sulfate, dexamethasone, daunorubicin hydrochloride & intrathecal triple therapy (ITT: methotrexate, therapeutic hydrocortisone and cytarabine)), consolidation (cytarabine, pegaspargase, filgrastim, testicular radiation therapy, re-induction (vincristine, dexamethasone, daunorubicin), and intensification chemotherapy (methotrexate, leucovorin calcium, mercaptopurine, etoposide, cyclophosphamide & ITT. | ||
All Cause Mortality |
||||
CNS Patients - Treatment (Combination Chemotherapy) | Testicular Relapse Patients (Combination Chemotherapy) | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
CNS Patients - Treatment (Combination Chemotherapy) | Testicular Relapse Patients (Combination Chemotherapy) | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 7/124 (5.6%) | 1/42 (2.4%) | ||
Blood and lymphatic system disorders | ||||
Disseminated intravascular coagulation | 1/124 (0.8%) | 1 | 0/42 (0%) | 0 |
Cardiac disorders | ||||
Cardiac disorders - Other | 1/124 (0.8%) | 1 | 0/42 (0%) | 0 |
General disorders | ||||
Death NOS | 1/124 (0.8%) | 1 | 0/42 (0%) | 0 |
Hepatobiliary disorders | ||||
Hepatic failure | 1/124 (0.8%) | 1 | 0/42 (0%) | 0 |
Infections and infestations | ||||
Infections and infestations - Other | 6/124 (4.8%) | 7 | 1/42 (2.4%) | 1 |
Lung infection | 1/124 (0.8%) | 1 | 0/42 (0%) | 0 |
Investigations | ||||
Activated partial thromboplastin time prolonged | 1/124 (0.8%) | 1 | 0/42 (0%) | 0 |
Alanine aminotransferase increased | 1/124 (0.8%) | 1 | 0/42 (0%) | 0 |
Aspartate aminotransferase increased | 1/124 (0.8%) | 1 | 0/42 (0%) | 0 |
Blood bilirubin increased | 1/124 (0.8%) | 1 | 0/42 (0%) | 0 |
Fibrinogen decreased | 1/124 (0.8%) | 1 | 0/42 (0%) | 0 |
GGT increased | 1/124 (0.8%) | 1 | 0/42 (0%) | 0 |
INR increased | 1/124 (0.8%) | 1 | 0/42 (0%) | 0 |
Platelet count decreased | 1/124 (0.8%) | 1 | 0/42 (0%) | 0 |
White blood cell decreased | 1/124 (0.8%) | 1 | 0/42 (0%) | 0 |
Metabolism and nutrition disorders | ||||
Acidosis | 1/124 (0.8%) | 1 | 0/42 (0%) | 0 |
Hyperglycemia | 1/124 (0.8%) | 1 | 0/42 (0%) | 0 |
Hyponatremia | 1/124 (0.8%) | 1 | 0/42 (0%) | 0 |
Respiratory, thoracic and mediastinal disorders | ||||
Adult respiratory distress syndrome | 2/124 (1.6%) | 2 | 0/42 (0%) | 0 |
Pneumonitis | 2/124 (1.6%) | 2 | 1/42 (2.4%) | 1 |
Vascular disorders | ||||
Thromboembolic event | 1/124 (0.8%) | 1 | 0/42 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||
CNS Patients - Treatment (Combination Chemotherapy) | Testicular Relapse Patients (Combination Chemotherapy) | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 119/124 (96%) | 41/42 (97.6%) | ||
Blood and lymphatic system disorders | ||||
Anemia | 52/124 (41.9%) | 65 | 12/42 (28.6%) | 15 |
Blood and lymphatic system disorders - Other | 2/124 (1.6%) | 2 | 0/42 (0%) | 0 |
Disseminated intravascular coagulation | 1/124 (0.8%) | 1 | 0/42 (0%) | 0 |
Febrile neutropenia | 81/124 (65.3%) | 86 | 27/42 (64.3%) | 30 |
Cardiac disorders | ||||
Sinus tachycardia | 0/124 (0%) | 0 | 1/42 (2.4%) | 1 |
Ear and labyrinth disorders | ||||
Middle ear inflammation | 3/124 (2.4%) | 3 | 0/42 (0%) | 0 |
Eye disorders | ||||
Extraocular muscle paresis | 1/124 (0.8%) | 1 | 0/42 (0%) | 0 |
Eye disorders - Other | 1/124 (0.8%) | 1 | 1/42 (2.4%) | 1 |
Photophobia | 1/124 (0.8%) | 1 | 0/42 (0%) | 0 |
Gastrointestinal disorders | ||||
Abdominal pain | 7/124 (5.6%) | 7 | 0/42 (0%) | 0 |
Anal mucositis | 2/124 (1.6%) | 2 | 0/42 (0%) | 0 |
Anal pain | 1/124 (0.8%) | 1 | 0/42 (0%) | 0 |
Colitis | 2/124 (1.6%) | 2 | 0/42 (0%) | 0 |
Constipation | 1/124 (0.8%) | 1 | 0/42 (0%) | 0 |
Diarrhea | 12/124 (9.7%) | 12 | 5/42 (11.9%) | 5 |
Dyspepsia | 1/124 (0.8%) | 1 | 0/42 (0%) | 0 |
Esophagitis | 1/124 (0.8%) | 1 | 0/42 (0%) | 0 |
Gastrointestinal disorders - Other | 1/124 (0.8%) | 1 | 0/42 (0%) | 0 |
Ileus | 1/124 (0.8%) | 1 | 0/42 (0%) | 0 |
Mucositis oral | 15/124 (12.1%) | 15 | 4/42 (9.5%) | 4 |
Nausea | 7/124 (5.6%) | 7 | 2/42 (4.8%) | 2 |
Oral pain | 5/124 (4%) | 5 | 1/42 (2.4%) | 1 |
Pancreatitis | 4/124 (3.2%) | 4 | 2/42 (4.8%) | 3 |
Rectal mucositis | 0/124 (0%) | 0 | 1/42 (2.4%) | 1 |
Rectal pain | 3/124 (2.4%) | 3 | 0/42 (0%) | 0 |
Stomach pain | 1/124 (0.8%) | 1 | 0/42 (0%) | 0 |
Typhlitis | 0/124 (0%) | 0 | 1/42 (2.4%) | 1 |
Vomiting | 8/124 (6.5%) | 8 | 0/42 (0%) | 0 |
General disorders | ||||
Death NOS | 0/124 (0%) | 0 | 1/42 (2.4%) | 1 |
Fatigue | 3/124 (2.4%) | 3 | 0/42 (0%) | 0 |
Fever | 13/124 (10.5%) | 13 | 6/42 (14.3%) | 6 |
Flu like symptoms | 2/124 (1.6%) | 2 | 0/42 (0%) | 0 |
General disorders and administration site conditions - Other | 3/124 (2.4%) | 3 | 0/42 (0%) | 0 |
Multi-organ failure | 1/124 (0.8%) | 1 | 0/42 (0%) | 0 |
Pain | 6/124 (4.8%) | 6 | 1/42 (2.4%) | 1 |
Sudden death NOS | 1/124 (0.8%) | 1 | 0/42 (0%) | 0 |
Hepatobiliary disorders | ||||
Hepatic failure | 1/124 (0.8%) | 1 | 0/42 (0%) | 0 |
Immune system disorders | ||||
Allergic reaction | 1/124 (0.8%) | 1 | 1/42 (2.4%) | 1 |
Anaphylaxis | 11/124 (8.9%) | 11 | 7/42 (16.7%) | 7 |
Cytokine release syndrome | 1/124 (0.8%) | 1 | 1/42 (2.4%) | 1 |
Immune system disorders - Other | 1/124 (0.8%) | 1 | 0/42 (0%) | 0 |
Serum sickness | 0/124 (0%) | 0 | 1/42 (2.4%) | 1 |
Infections and infestations | ||||
Abdominal infection | 1/124 (0.8%) | 1 | 0/42 (0%) | 0 |
Anorectal infection | 2/124 (1.6%) | 2 | 0/42 (0%) | 0 |
Arteritis infective | 1/124 (0.8%) | 1 | 0/42 (0%) | 0 |
Bladder infection | 1/124 (0.8%) | 1 | 0/42 (0%) | 0 |
Bronchial infection | 0/124 (0%) | 0 | 1/42 (2.4%) | 1 |
Catheter related infection | 10/124 (8.1%) | 10 | 3/42 (7.1%) | 3 |
Enterocolitis infectious | 6/124 (4.8%) | 6 | 0/42 (0%) | 0 |
Eye infection | 1/124 (0.8%) | 1 | 0/42 (0%) | 0 |
Gum infection | 1/124 (0.8%) | 1 | 0/42 (0%) | 0 |
Infections and infestations - Other | 82/124 (66.1%) | 90 | 23/42 (54.8%) | 25 |
Joint infection | 1/124 (0.8%) | 1 | 0/42 (0%) | 0 |
Lung infection | 10/124 (8.1%) | 10 | 2/42 (4.8%) | 2 |
Meningitis | 2/124 (1.6%) | 2 | 0/42 (0%) | 0 |
Mucosal infection | 2/124 (1.6%) | 2 | 0/42 (0%) | 0 |
Otitis externa | 4/124 (3.2%) | 4 | 0/42 (0%) | 0 |
Otitis media | 1/124 (0.8%) | 1 | 0/42 (0%) | 0 |
Penile infection | 1/124 (0.8%) | 1 | 0/42 (0%) | 0 |
Pharyngitis | 2/124 (1.6%) | 2 | 0/42 (0%) | 0 |
Salivary gland infection | 1/124 (0.8%) | 1 | 0/42 (0%) | 0 |
Sepsis | 4/124 (3.2%) | 4 | 1/42 (2.4%) | 1 |
Sinusitis | 2/124 (1.6%) | 2 | 1/42 (2.4%) | 1 |
Skin infection | 4/124 (3.2%) | 4 | 2/42 (4.8%) | 2 |
Small intestine infection | 1/124 (0.8%) | 1 | 1/42 (2.4%) | 1 |
Upper respiratory infection | 4/124 (3.2%) | 4 | 2/42 (4.8%) | 2 |
Urinary tract infection | 7/124 (5.6%) | 7 | 1/42 (2.4%) | 1 |
Wound infection | 3/124 (2.4%) | 3 | 0/42 (0%) | 0 |
Injury, poisoning and procedural complications | ||||
Dermatitis radiation | 0/124 (0%) | 0 | 2/42 (4.8%) | 2 |
Fracture | 1/124 (0.8%) | 1 | 0/42 (0%) | 0 |
Intraoperative venous injury | 1/124 (0.8%) | 1 | 0/42 (0%) | 0 |
Investigations | ||||
Activated partial thromboplastin time prolonged | 4/124 (3.2%) | 4 | 0/42 (0%) | 0 |
Alanine aminotransferase increased | 64/124 (51.6%) | 71 | 12/42 (28.6%) | 14 |
Alkaline phosphatase increased | 1/124 (0.8%) | 1 | 0/42 (0%) | 0 |
Aspartate aminotransferase increased | 35/124 (28.2%) | 35 | 4/42 (9.5%) | 5 |
Blood bilirubin increased | 7/124 (5.6%) | 7 | 1/42 (2.4%) | 1 |
Cholesterol high | 2/124 (1.6%) | 2 | 0/42 (0%) | 0 |
Creatinine increased | 2/124 (1.6%) | 2 | 0/42 (0%) | 0 |
Electrocardiogram QT corrected interval prolonged | 0/124 (0%) | 0 | 1/42 (2.4%) | 1 |
Fibrinogen decreased | 1/124 (0.8%) | 1 | 1/42 (2.4%) | 1 |
GGT increased | 6/124 (4.8%) | 6 | 0/42 (0%) | 0 |
Investigations - Other | 1/124 (0.8%) | 1 | 0/42 (0%) | 0 |
Lipase increased | 9/124 (7.3%) | 10 | 1/42 (2.4%) | 1 |
Lymphocyte count decreased | 3/124 (2.4%) | 5 | 1/42 (2.4%) | 2 |
Neutrophil count decreased | 98/124 (79%) | 130 | 33/42 (78.6%) | 42 |
Platelet count decreased | 73/124 (58.9%) | 97 | 16/42 (38.1%) | 23 |
Serum amylase increased | 4/124 (3.2%) | 4 | 0/42 (0%) | 0 |
Weight gain | 2/124 (1.6%) | 2 | 1/42 (2.4%) | 1 |
White blood cell decreased | 63/124 (50.8%) | 93 | 14/42 (33.3%) | 19 |
Metabolism and nutrition disorders | ||||
Anorexia | 5/124 (4%) | 5 | 3/42 (7.1%) | 3 |
Dehydration | 8/124 (6.5%) | 8 | 6/42 (14.3%) | 6 |
Glucose intolerance | 1/124 (0.8%) | 1 | 0/42 (0%) | 0 |
Hyperglycemia | 9/124 (7.3%) | 9 | 5/42 (11.9%) | 7 |
Hyperkalemia | 1/124 (0.8%) | 1 | 0/42 (0%) | 0 |
Hypertriglyceridemia | 2/124 (1.6%) | 2 | 1/42 (2.4%) | 1 |
Hypoalbuminemia | 3/124 (2.4%) | 3 | 0/42 (0%) | 0 |
Hypocalcemia | 6/124 (4.8%) | 6 | 0/42 (0%) | 0 |
Hypoglycemia | 1/124 (0.8%) | 1 | 0/42 (0%) | 0 |
Hypokalemia | 30/124 (24.2%) | 35 | 9/42 (21.4%) | 9 |
Hypomagnesemia | 1/124 (0.8%) | 1 | 0/42 (0%) | 0 |
Hyponatremia | 12/124 (9.7%) | 12 | 3/42 (7.1%) | 3 |
Hypophosphatemia | 4/124 (3.2%) | 4 | 1/42 (2.4%) | 1 |
Musculoskeletal and connective tissue disorders | ||||
Arthralgia | 1/124 (0.8%) | 1 | 0/42 (0%) | 0 |
Avascular necrosis | 3/124 (2.4%) | 3 | 0/42 (0%) | 0 |
Back pain | 6/124 (4.8%) | 6 | 0/42 (0%) | 0 |
Bone pain | 3/124 (2.4%) | 3 | 1/42 (2.4%) | 1 |
Muscle weakness lower limb | 1/124 (0.8%) | 1 | 0/42 (0%) | 0 |
Musculoskeletal and connective tissue disorder - Other | 1/124 (0.8%) | 1 | 0/42 (0%) | 0 |
Myalgia | 2/124 (1.6%) | 2 | 0/42 (0%) | 0 |
Myositis | 1/124 (0.8%) | 1 | 0/42 (0%) | 0 |
Neck pain | 0/124 (0%) | 0 | 1/42 (2.4%) | 1 |
Pain in extremity | 5/124 (4%) | 5 | 3/42 (7.1%) | 3 |
Nervous system disorders | ||||
Ataxia | 1/124 (0.8%) | 1 | 0/42 (0%) | 0 |
Cognitive disturbance | 1/124 (0.8%) | 1 | 0/42 (0%) | 0 |
Depressed level of consciousness | 1/124 (0.8%) | 1 | 0/42 (0%) | 0 |
Dizziness | 1/124 (0.8%) | 1 | 1/42 (2.4%) | 1 |
Dysphasia | 1/124 (0.8%) | 1 | 0/42 (0%) | 0 |
Headache | 7/124 (5.6%) | 7 | 0/42 (0%) | 0 |
Memory impairment | 1/124 (0.8%) | 1 | 0/42 (0%) | 0 |
Neuralgia | 1/124 (0.8%) | 1 | 0/42 (0%) | 0 |
Peripheral motor neuropathy | 9/124 (7.3%) | 9 | 2/42 (4.8%) | 2 |
Peripheral sensory neuropathy | 8/124 (6.5%) | 8 | 3/42 (7.1%) | 3 |
Seizure | 2/124 (1.6%) | 2 | 0/42 (0%) | 0 |
Sinus pain | 1/124 (0.8%) | 1 | 0/42 (0%) | 0 |
Syncope | 1/124 (0.8%) | 1 | 0/42 (0%) | 0 |
Psychiatric disorders | ||||
Agitation | 1/124 (0.8%) | 1 | 1/42 (2.4%) | 1 |
Anxiety | 1/124 (0.8%) | 1 | 0/42 (0%) | 0 |
Confusion | 1/124 (0.8%) | 1 | 0/42 (0%) | 0 |
Depression | 2/124 (1.6%) | 2 | 0/42 (0%) | 0 |
Insomnia | 1/124 (0.8%) | 1 | 0/42 (0%) | 0 |
Personality change | 2/124 (1.6%) | 2 | 1/42 (2.4%) | 1 |
Psychosis | 1/124 (0.8%) | 1 | 0/42 (0%) | 0 |
Renal and urinary disorders | ||||
Acute kidney injury | 2/124 (1.6%) | 2 | 0/42 (0%) | 0 |
Proteinuria | 1/124 (0.8%) | 1 | 0/42 (0%) | 0 |
Renal calculi | 0/124 (0%) | 0 | 1/42 (2.4%) | 1 |
Urinary tract obstruction | 1/124 (0.8%) | 1 | 0/42 (0%) | 0 |
Urinary tract pain | 1/124 (0.8%) | 1 | 0/42 (0%) | 0 |
Reproductive system and breast disorders | ||||
Penile pain | 1/124 (0.8%) | 1 | 0/42 (0%) | 0 |
Perineal pain | 1/124 (0.8%) | 1 | 0/42 (0%) | 0 |
Vaginal inflammation | 1/124 (0.8%) | 1 | 0/42 (0%) | 0 |
Respiratory, thoracic and mediastinal disorders | ||||
Apnea | 0/124 (0%) | 0 | 1/42 (2.4%) | 1 |
Bronchopulmonary hemorrhage | 1/124 (0.8%) | 1 | 0/42 (0%) | 0 |
Cough | 4/124 (3.2%) | 4 | 0/42 (0%) | 0 |
Dyspnea | 0/124 (0%) | 0 | 1/42 (2.4%) | 1 |
Epistaxis | 3/124 (2.4%) | 3 | 0/42 (0%) | 0 |
Hiccups | 1/124 (0.8%) | 1 | 0/42 (0%) | 0 |
Hypoxia | 4/124 (3.2%) | 4 | 1/42 (2.4%) | 1 |
Pharyngeal mucositis | 1/124 (0.8%) | 1 | 0/42 (0%) | 0 |
Pharyngolaryngeal pain | 1/124 (0.8%) | 1 | 0/42 (0%) | 0 |
Pneumonitis | 7/124 (5.6%) | 7 | 2/42 (4.8%) | 2 |
Respiratory, thoracic and mediastinal disorders - Other | 3/124 (2.4%) | 3 | 0/42 (0%) | 0 |
Skin and subcutaneous tissue disorders | ||||
Pain of skin | 1/124 (0.8%) | 1 | 1/42 (2.4%) | 1 |
Purpura | 1/124 (0.8%) | 1 | 0/42 (0%) | 0 |
Rash acneiform | 1/124 (0.8%) | 1 | 0/42 (0%) | 0 |
Rash maculo-papular | 1/124 (0.8%) | 1 | 0/42 (0%) | 0 |
Skin and subcutaneous tissue disorders - Other | 2/124 (1.6%) | 2 | 0/42 (0%) | 0 |
Vascular disorders | ||||
Capillary leak syndrome | 0/124 (0%) | 0 | 1/42 (2.4%) | 1 |
Hypertension | 2/124 (1.6%) | 2 | 0/42 (0%) | 0 |
Hypotension | 4/124 (3.2%) | 4 | 3/42 (7.1%) | 3 |
Thromboembolic event | 1/124 (0.8%) | 1 | 3/42 (7.1%) | 3 |
Vascular disorders - Other | 1/124 (0.8%) | 1 | 0/42 (0%) | 0 |
Limitations/Caveats
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 |
- AALL02P2
- COG-AALL02P2
- NCI-2011-01623