Combination Chemotherapy in Treating Young Patients With Down Syndrome and Acute Myeloid Leukemia or Myelodysplastic Syndromes
Study Details
Study Description
Brief Summary
This phase III trial is studying how well combination chemotherapy works in treating young patients with Down syndrome and acute myeloid leukemia or myelodysplastic syndromes. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.
Detailed Description
PRIMARY OBJECTIVES:
-
Determine the event-free survival (EFS) and overall survival rates in pediatric patients with Down syndrome (DS) and acute myeloid leukemia AML or myelodysplastic syndromes MDS treated with induction therapy comprising cytarabine, daunorubicin hydrochloride, thioguanine, and asparaginase followed by intensification therapy comprising cytarabine and etoposide.
-
Determine if the EFS rate in these patients can be increased with an intensified course of cytarabine therapy during induction therapy, compared to the EFS rate of patients in protocol COG-A2971.
-
Determine if the number of intrathecal chemotherapy treatments can be reduced in these patients.
-
Determine if the total cumulative anthracycline dose can be reduced in these patients.
SECONDARY OBJECTIVES:
-
Determine the type and degree of treatment-related toxicity in these patients.
-
Determine the prevalence of leukemia phenotype and globin transcription factor 1 (GATA1) mutations of DS patients < 4 years of age at diagnosis.
-
Determine the relationship of GATA1 mutations with leukemia phenotype and EFS rates of DS patients < 4 years of age at diagnosis.
-
Determine the relationship of minimal residual disease monitored by flow cytometry and remission status during and after completion of therapy based on bone marrow morphology.
-
Examine parameters of in vitro drug sensitivity and in vivo Ara-C pharmacokinetics.
-
Examine gene expression profiles by microarrays and the relationship to leukemia phenotype and outcome.
-
Examine the relationship of functional polymorphisms in phase I and phase II detoxification genes and DNA repair pathways that may modify susceptibility to leukemia and outcome of therapy in DS children.
-
Assess the effect of karyotypic abnormalities on survival. IX. Establish a DS leukemia cell bank for future biological studies.
OUTLINE: This is a nonrandomized, multicenter study.
INDUCTION THERAPY: Patients undergo 4 courses of induction therapy. Each course is 28 days.
COURSE I: Patients receive intrathecal (IT) cytarabine on day 1* and cytarabine IV continuously over 96 hours, daunorubicin hydrochloride IV continuously over 96 hours, and oral thioguanine twice daily on days 1-4.
NOTE: *Patients with Central Nervous System (CNS) disease receive cytarabine IT twice weekly for up to 6 doses; patients with persistent CNS leukemia after 6 doses of IT cytarabine are removed from the study.
COURSE II: Patients receive high-dose cytarabine IV over 3 hours twice daily on days 1, 2, 8, and 9 and asparaginase intramuscularly (IM) on days 2 and 9.
COURSE III: Patients receive treatment as in course 1.
COURSE IV: Patients receive cytarabine IV, daunorubicin hydrochloride IV, and oral thioguanine as in course 1.
Induction therapy continues in the absence of disease progression or unacceptable toxicity. Patients with partial response, relapsed, or refractory disease after completion of course 4 are taken off study. Patients achieving complete response proceed to intensification therapy.
INTENSIFICATION THERAPY: Patients receive cytarabine IV continuously over 168 hours on days 1-7 and etoposide IV over 1 hour on days 1-3. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up periodically for 5 years and then annually thereafter.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Treatment (combination chemotherapy) INDUCTION THERAPY COURSE I: Patients receive cytarabine IT on day 1 and cytarabine IV continuously over 96 hours, daunorubicin hydrochloride IV continuously, and oral thioguanine BID on days 1-4. COURSE II: Patients receive high-dose cytarabine IV over 3 hours BID on days 1, 2, 8, and 9 and asparaginase (IM) on days 2 and 9. COURSE III: Patients receive treatment as in course I. COURSE IV: Patients receive cytarabine IV, daunorubicin hydrochloride IV, and oral thioguanine as in course I INTENSIFICATION THERAPY: Patients receive cytarabine IV continuously over 168 hours on days 1-7 and etoposide IV over 1 hour on days 1-3. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. |
Drug: asparaginase
Given IM
Other Names:
Drug: daunorubicin hydrochloride
Given IV
Other Names:
Drug: cytarabine
Given IV or IT
Other Names:
Drug: thioguanine
Given orally
Other Names:
Drug: etoposide
Given IV
Other Names:
Other: laboratory biomarker analysis
Correlative studies
|
Outcome Measures
Primary Outcome Measures
- Event-free Survival (EFS) at 3 Years [Time from study entry to induction failure, relapse, or death assessed at 3 years.]
- Overall Survival (OS) at 3 Years [Time from study entry to death, assessed at 3 years.]
Secondary Outcome Measures
- Induction Remission Rate [End of induction therapy (day 112)]
Proportion of participants with a remission after four courses of Induction therapy.
- Percentage of Patients Experiencing Grade 3 or 4 Toxicity Assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 [From the beginning of induction therapy to the end of intensification therapy]
Proportion of participants with at least one grade 3 or higher adverse event during therapy.
- Prevalence of Leukemia Phenotype of DS Patients < 4 Years of Age at Diagnosis by Flow Cytometry [At the start of therapy]
Proportion of participants having megakaryoblastic subtype (AMkL) phenotype among patients with phenotype data available.
- Prevalence of of GATA1 Mutations of DS Patients < 4 Years of Age at Diagnosis [At baseline and at the end of therapy (intensification) or disease relapse]
Proportion of participants having GATA1 mutation among patients with phenotype data available.
- Proportions of Patients in Morphologic Remission With Positive MRD by Flow Cytometry [After Induction I therapy (day 28 from start of therapy)]
Proportion of participants in complete remission by morphology and with positive MRD by flow cytometry among patients having evaluable remission and MRD assessment.
- Cytarabine Drug Sensitivity by R-Strip (MicroMath) Curve Fitting Program [Days 1, 2, 8, and 9 of induction II]
Mean and standard deviation of peak plasma concentration. Specimen draws were performed only with dose 1, day 1 of induction II of AraC. First sample drawn pre-infusion, then drawn 30 mins prior to the end of the infusion, and then drawn for 6 time periods post infusion up to 8 hours post infusion (and before the 2nd dose of AraC). Results are based from these multiple time points on Day 1 of Induction II only.
- Cytarabine Drug Sensitivity by R-Strip (MicroMath) Curve Fitting Program [Days 1, 2, 8, and 9 of induction II]
Mean and standard deviation of area under the concentration time curve. Specimen draws were performed only with dose 1, day 1 of induction II of AraC. First sample drawn pre-infusion, then drawn 30 mins prior to the end of the infusion, and then drawn for 6 time periods post infusion up to 8 hours post infusion (and before the 2nd dose of AraC). Results are based from these multiple time points on Day 1 of Induction II only.
- Cytarabine Drug Sensitivity by R-Strip (MicroMath) Curve Fitting Program [Days 1, 2, 8, and 9 of induction II]
Mean and standard deviation of half-life of elimination. Specimen draws were performed only with dose 1, day 1 of induction II of AraC. First sample drawn pre-infusion, then drawn 30 mins prior to the end of the infusion, and then drawn for 6 time periods post infusion up to 8 hours post infusion (and before the 2nd dose of AraC). Results are based from these multiple time points on Day 1 of Induction II only.
- Gene Expression Profiles by Microarrays [At baseline and at the time of relapse (if available)]
A hierarchical clustering algorithm is used to assemble the genes into a dendrogram or tree structure with branches containing genes with similar patterns of expression. This ordered representation can be graphically displayed with colors that reflect the qualitative and quantitative relationships of the expressed genes.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Diagnosis DS or DS mosaicism by karyotype or chromosomal analysis
-
Diagnosis of myelodysplastic syndromes (MDS) with < 30% blasts or acute myeloid leukemia (AML)
-
Newly diagnosed disease
-
Patients with a history of transient myeloproliferative disorder (TMD) are eligible provided the patient is diagnosed with AML or MDS at > 90 days of age AND meets either of the following criteria:
-
At least 30% blasts in the bone marrow regardless of time since resolution of TMD
-
More than 8 weeks since resolution of TMD with ≥ 5% blasts in the bone marrow
-
Immunophenotype required for study entry
-
No promyelocytic leukemia
-
Shortening fraction ≥ 27% by echocardiogram OR ejection fraction ≥ 50% by radionuclide angiogram
-
Bilirubin ≤ 1.5 times upper limit of normal (ULN)
-
AST or ALT < 2.5 times ULN
-
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])
-
Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min
-
No evidence of dyspnea at rest
-
No exercise intolerance
-
Pulse oximetry > 94%
-
No prior chemotherapy, radiotherapy, or any antileukemic therapy
-
Intrathecal cytarabine therapy given at diagnosis allowed
-
Prior therapy for TMD allowed
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Phoenix Childrens Hospital | Phoenix | Arizona | United States | 85016 |
2 | Southern California Permanente Medical Group | Downey | California | United States | 90242 |
3 | Miller Children's Hospital | Long Beach | California | United States | 90806 |
4 | Children's Hospital Los Angeles | Los Angeles | California | United States | 90027 |
5 | Children's Hospital Central California | Madera | California | United States | 93636-8762 |
6 | Children's Hospital and Research Center at Oakland | Oakland | California | United States | 94609-1809 |
7 | Kaiser Permanente-Oakland | Oakland | California | United States | 94611 |
8 | Childrens Hospital of Orange County | Orange | California | United States | 92868-3874 |
9 | Lucile Packard Children's Hospital Stanford University | Palo Alto | California | United States | 94304 |
10 | Rady Children's Hospital - San Diego | San Diego | California | United States | 92123 |
11 | University of California San Francisco Medical Center-Parnassus | San Francisco | California | United States | 94143 |
12 | Children's Hospital Colorado | Aurora | Colorado | United States | 80045 |
13 | Alfred I duPont Hospital for Children | Wilmington | Delaware | United States | 19803 |
14 | Children's National Medical Center | Washington | District of Columbia | United States | 20010 |
15 | Lombardi Comprehensive Cancer Center at Georgetown University | Washington | District of Columbia | United States | 20057 |
16 | Broward Health Medical Center | Fort Lauderdale | Florida | United States | 33316 |
17 | Memorial Healthcare System - Joe DiMaggio Children's Hospital | Hollywood | Florida | United States | 33021 |
18 | Nemours Children's Clinic - Jacksonville | Jacksonville | Florida | United States | 32207-8426 |
19 | Florida Hospital | Orlando | Florida | United States | 32803 |
20 | All Children's Hospital | Saint Petersburg | Florida | United States | 33701 |
21 | Children's Healthcare of Atlanta - Egleston | Atlanta | Georgia | United States | 30322 |
22 | University of Hawaii | Honolulu | Hawaii | United States | 96813 |
23 | Saint Luke's Mountain States Tumor Institute | Boise | Idaho | United States | 83712 |
24 | Lurie Children's Hospital-Chicago | Chicago | Illinois | United States | 60614 |
25 | Loyola University Medical Center | Maywood | Illinois | United States | 60153 |
26 | Advocate Lutheran General Hospital. | Park Ridge | Illinois | United States | 60068 |
27 | Saint Jude Midwest Affiliate | Peoria | Illinois | United States | 61602 |
28 | Southern Illinois University | Springfield | Illinois | United States | 62702 |
29 | Indiana University Medical Center | Indianapolis | Indiana | United States | 46202 |
30 | Riley Hospital for Children | Indianapolis | Indiana | United States | 46202 |
31 | Saint Vincent Hospital and Health Services | Indianapolis | Indiana | United States | 46260 |
32 | Kosair Children's Hospital | Louisville | Kentucky | United States | 40202 |
33 | Tulane University Health Sciences Center | New Orleans | Louisiana | United States | 70112 |
34 | Eastern Maine Medical Center | Bangor | Maine | United States | 04401 |
35 | Sinai Hospital of Baltimore | Baltimore | Maryland | United States | 21215 |
36 | Johns Hopkins University-Sidney Kimmel Cancer Center | Baltimore | Maryland | United States | 21287 |
37 | Walter Reed National Military Medical Center | Bethesda | Maryland | United States | 20889-5600 |
38 | C S Mott Children's Hospital | Ann Arbor | Michigan | United States | 48109 |
39 | Wayne State University-Karmanos Cancer Institute | Detroit | Michigan | United States | 48201 |
40 | Saint John Hospital and Medical Center | Detroit | Michigan | United States | 48236 |
41 | Hurley Medical Center | Flint | Michigan | United States | 48502 |
42 | Helen DeVos Children's Hospital at Spectrum Health | Grand Rapids | Michigan | United States | 49503 |
43 | Children's Hospitals and Clinics of Minnesota - Minneapolis | Minneapolis | Minnesota | United States | 55404 |
44 | University of Minnesota Medical Center-Fairview | Minneapolis | Minnesota | United States | 55455 |
45 | University of Mississippi Medical Center | Jackson | Mississippi | United States | 39216 |
46 | The Childrens Mercy Hospital | Kansas City | Missouri | United States | 64108 |
47 | Children's Hospital and Medical Center of Omaha | Omaha | Nebraska | United States | 68114 |
48 | University of Nebraska Medical Center | Omaha | Nebraska | United States | 68198 |
49 | Nevada Cancer Research Foundation CCOP | Las Vegas | Nevada | United States | 89106 |
50 | Hackensack University Medical Center | Hackensack | New Jersey | United States | 07601 |
51 | Saint Peter's University Hospital | New Brunswick | New Jersey | United States | 08901 |
52 | UMDNJ - Robert Wood Johnson University Hospital | New Brunswick | New Jersey | United States | 08903 |
53 | Newark Beth Israel Medical Center | Newark | New Jersey | United States | 07112 |
54 | Roswell Park Cancer Institute | Buffalo | New York | United States | 14263 |
55 | Columbia University Medical Center | New York | New York | United States | 10032 |
56 | Memorial Sloan-Kettering Cancer Center | New York | New York | United States | 10065 |
57 | University of Rochester | Rochester | New York | United States | 14642 |
58 | State University of New York Upstate Medical University | Syracuse | New York | United States | 13210 |
59 | Ny Cancer% | Valhalla | New York | United States | 10595 |
60 | University of North Carolina | Chapel Hill | North Carolina | United States | 27599 |
61 | Carolinas Medical Center | Charlotte | North Carolina | United States | 28203 |
62 | Duke University Medical Center | Durham | North Carolina | United States | 27710 |
63 | Sanford Medical Center-Fargo | Fargo | North Dakota | United States | 58122 |
64 | Children's Hospital Medical Center of Akron | Akron | Ohio | United States | 44308 |
65 | Cleveland Clinic Foundation | Cleveland | Ohio | United States | 44195 |
66 | Nationwide Children's Hospital | Columbus | Ohio | United States | 43205 |
67 | University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | United States | 73104 |
68 | Legacy Emanuel Hospital and Health Center | Portland | Oregon | United States | 97227 |
69 | Oregon Health and Science University | Portland | Oregon | United States | 97239 |
70 | Penn State Hershey Children's Hospital | Hershey | Pennsylvania | United States | 17033 |
71 | Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | United States | 19104 |
72 | Saint Christopher's Hospital for Children | Philadelphia | Pennsylvania | United States | 19134 |
73 | Children's Hospital of Pittsburgh of UPMC | Pittsburgh | Pennsylvania | United States | 15224 |
74 | Rhode Island Hospital | Providence | Rhode Island | United States | 02903 |
75 | Palmetto Health Richland | Columbia | South Carolina | United States | 29203 |
76 | St. Jude Children's Research Hospital | Memphis | Tennessee | United States | 38105 |
77 | Vanderbilt-Ingram Cancer Center | Nashville | Tennessee | United States | 37232 |
78 | University of Texas Southwestern Medical Center | Dallas | Texas | United States | 75390 |
79 | Cook Children's Medical Center | Fort Worth | Texas | United States | 76104 |
80 | Baylor College of Medicine | Houston | Texas | United States | 77030 |
81 | Covenant Children's Hospital | Lubbock | Texas | United States | 79410 |
82 | University of Texas Health Science Center at San Antonio | San Antonio | Texas | United States | 78229-3900 |
83 | Primary Children's Hospital | Salt Lake City | Utah | United States | 84113 |
84 | University of Vermont | Burlington | Vermont | United States | 05401 |
85 | Childrens Hospital-King's Daughters | Norfolk | Virginia | United States | 23507 |
86 | Seattle Children's Hospital | Seattle | Washington | United States | 98105 |
87 | Mary Bridge Children's Hospital and Health Center | Tacoma | Washington | United States | 98405 |
88 | Midwest Children's Cancer Center | Milwaukee | Wisconsin | United States | 53226 |
89 | Princess Margaret Hospital for Children | Perth | Western Australia | Australia | 6008 |
90 | British Columbia Children's Hospital | Vancouver | British Columbia | Canada | V6H 3V4 |
91 | CancerCare Manitoba | Winnipeg | Manitoba | Canada | R3E 0V9 |
92 | Janeway Child Health Centre | Saint John's | Newfoundland and Labrador | Canada | A1B 3V6 |
93 | Cancer Centre of Southeastern Ontario at Kingston General Hospital | Kingston | Ontario | Canada | K7L 5P9 |
94 | Children's Hospital | London | Ontario | Canada | N6A 5W9 |
95 | Children's Hospital of Eastern Ontario | Ottawa | Ontario | Canada | K1H 8L1 |
96 | Hospital for Sick Children | Toronto | Ontario | Canada | M5G 1X8 |
97 | San Jorge Children's Hospital | Santurce | Puerto Rico | 00912 |
Sponsors and Collaborators
- Children's Oncology Group
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Jeffrey Taub, MD, Children's Oncology Group
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- AAML0431
- NCI-2009-00318
- CDR0000492776
- COG-AAML0431
- AAML0431
- U10CA098543
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | Treatment (Combination Chemotherapy) |
---|---|
Arm/Group Description | INDUCTION THERAPY COURSE I: Patients receive cytarabine IT on day 1 and cytarabine IV continuously over 96 hours, daunorubicin hydrochloride IV continuously, and oral thioguanine BID on days 1-4. COURSE II: Patients receive high-dose cytarabine IV over 3 hours BID on days 1, 2, 8, and 9 and asparaginase (IM) on days 2 and 9. COURSE III: Patients receive treatment as in course I. COURSE IV: Patients receive cytarabine IV, daunorubicin hydrochloride IV, and oral thioguanine as in course I INTENSIFICATION THERAPY: Patients receive cytarabine IV continuously over 168 hours on days 1-7 and etoposide IV over 1 hour on days 1-3. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. asparaginase: Given IM daunorubicin hydrochloride: Given IV cytarabine: Given IV or IT thioguanine: Given orally etoposide: Given IV laboratory biomarker analysis: Correlative studies |
Period Title: Overall Study | |
STARTED | 205 |
COMPLETED | 185 |
NOT COMPLETED | 20 |
Baseline Characteristics
Arm/Group Title | Treatment (Combination Chemotherapy) |
---|---|
Arm/Group Description | INDUCTION THERAPY COURSE I: Patients receive cytarabine IT on day 1 and cytarabine IV continuously over 96 hours, daunorubicin hydrochloride IV continuously, and oral thioguanine BID on days 1-4. COURSE II: Patients receive high-dose cytarabine IV over 3 hours BID on days 1, 2, 8, and 9 and asparaginase (IM) on days 2 and 9. COURSE III: Patients receive treatment as in course I. COURSE IV: Patients receive cytarabine IV, daunorubicin hydrochloride IV, and oral thioguanine as in course I INTENSIFICATION THERAPY: Patients receive cytarabine IV continuously over 168 hours on days 1-7 and etoposide IV over 1 hour on days 1-3. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. asparaginase: Given IM daunorubicin hydrochloride: Given IV cytarabine: Given IV or IT thioguanine: Given orally etoposide: Given IV laboratory biomarker analysis: Correlative studies |
Overall Participants | 205 |
Age (days) [Mean (Standard Deviation) ] | |
Mean (Standard Deviation) [days] |
616.41
(265.73)
|
Age (Count of Participants) | |
<=18 years |
205
100%
|
Between 18 and 65 years |
0
0%
|
>=65 years |
0
0%
|
Sex: Female, Male (Count of Participants) | |
Female |
106
51.7%
|
Male |
99
48.3%
|
Race (NIH/OMB) (Count of Participants) | |
American Indian or Alaska Native |
0
0%
|
Asian |
12
5.9%
|
Native Hawaiian or Other Pacific Islander |
2
1%
|
Black or African American |
28
13.7%
|
White |
141
68.8%
|
More than one race |
0
0%
|
Unknown or Not Reported |
22
10.7%
|
Ethnicity (NIH/OMB) (Count of Participants) | |
Hispanic or Latino |
48
23.4%
|
Not Hispanic or Latino |
154
75.1%
|
Unknown or Not Reported |
3
1.5%
|
Region of Enrollment (participants) [Number] | |
United States |
187
91.2%
|
Canada |
11
5.4%
|
Australia |
7
3.4%
|
Outcome Measures
Title | Event-free Survival (EFS) at 3 Years |
---|---|
Description | |
Time Frame | Time from study entry to induction failure, relapse, or death assessed at 3 years. |
Outcome Measure Data
Analysis Population Description |
---|
Ineligible patients are excluded from analyses of event free survival and overall survival. |
Arm/Group Title | Treatment (Combination Chemotherapy) |
---|---|
Arm/Group Description | INDUCTION THERAPY COURSE I: Patients receive cytarabine IT on day 1 and cytarabine IV continuously over 96 hours, daunorubicin hydrochloride IV continuously, and oral thioguanine BID on days 1-4. COURSE II: Patients receive high-dose cytarabine IV over 3 hours BID on days 1, 2, 8, and 9 and asparaginase (IM) on days 2 and 9. COURSE III: Patients receive treatment as in course I. COURSE IV: Patients receive cytarabine IV, daunorubicin hydrochloride IV, and oral thioguanine as in course I INTENSIFICATION THERAPY: Patients receive cytarabine IV continuously over 168 hours on days 1-7 and etoposide IV over 1 hour on days 1-3. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. asparaginase: Given IM daunorubicin hydrochloride: Given IV cytarabine: Given IV or IT thioguanine: Given orally etoposide: Given IV laboratory biomarker analysis: Correlative studies |
Measure Participants | 204 |
Number (95% Confidence Interval) [percentage] |
90.1
|
Title | Overall Survival (OS) at 3 Years |
---|---|
Description | |
Time Frame | Time from study entry to death, assessed at 3 years. |
Outcome Measure Data
Analysis Population Description |
---|
Ineligible patients are excluded from analyses of overall survival and event free survival. |
Arm/Group Title | Treatment (Combination Chemotherapy) |
---|---|
Arm/Group Description | INDUCTION THERAPY COURSE I: Patients receive cytarabine IT on day 1 and cytarabine IV continuously over 96 hours, daunorubicin hydrochloride IV continuously, and oral thioguanine BID on days 1-4. COURSE II: Patients receive high-dose cytarabine IV over 3 hours BID on days 1, 2, 8, and 9 and asparaginase (IM) on days 2 and 9. COURSE III: Patients receive treatment as in course I. COURSE IV: Patients receive cytarabine IV, daunorubicin hydrochloride IV, and oral thioguanine as in course I INTENSIFICATION THERAPY: Patients receive cytarabine IV continuously over 168 hours on days 1-7 and etoposide IV over 1 hour on days 1-3. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. asparaginase: Given IM daunorubicin hydrochloride: Given IV cytarabine: Given IV or IT thioguanine: Given orally etoposide: Given IV laboratory biomarker analysis: Correlative studies |
Measure Participants | 204 |
Number (95% Confidence Interval) [percentage] |
92.7
|
Title | Induction Remission Rate |
---|---|
Description | Proportion of participants with a remission after four courses of Induction therapy. |
Time Frame | End of induction therapy (day 112) |
Outcome Measure Data
Analysis Population Description |
---|
Ineligible (n=1) patients are excluded. Patients who withdrew from therapy before completing 4 courses of Induction and did not die or relapse are not evaluable (n=9) for Induction remission rate. |
Arm/Group Title | Treatment (Combination Chemotherapy) |
---|---|
Arm/Group Description | INDUCTION THERAPY COURSE I: Patients receive cytarabine IT on day 1 and cytarabine IV continuously over 96 hours, daunorubicin hydrochloride IV continuously, and oral thioguanine BID on days 1-4. COURSE II: Patients receive high-dose cytarabine IV over 3 hours BID on days 1, 2, 8, and 9 and asparaginase (IM) on days 2 and 9. COURSE III: Patients receive treatment as in course I. COURSE IV: Patients receive cytarabine IV, daunorubicin hydrochloride IV, and oral thioguanine as in course I INTENSIFICATION THERAPY: Patients receive cytarabine IV continuously over 168 hours on days 1-7 and etoposide IV over 1 hour on days 1-3. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. asparaginase: Given IM daunorubicin hydrochloride: Given IV cytarabine: Given IV or IT thioguanine: Given orally etoposide: Given IV laboratory biomarker analysis: Correlative studies |
Measure Participants | 195 |
Number [Proportion of participants] |
0.984615
0.5%
|
Title | Percentage of Patients Experiencing Grade 3 or 4 Toxicity Assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 |
---|---|
Description | Proportion of participants with at least one grade 3 or higher adverse event during therapy. |
Time Frame | From the beginning of induction therapy to the end of intensification therapy |
Outcome Measure Data
Analysis Population Description |
---|
Ineligible patients (n=1) are excluded. |
Arm/Group Title | Treatment (Combination Chemotherapy) |
---|---|
Arm/Group Description | INDUCTION THERAPY COURSE I: Patients receive cytarabine IT on day 1 and cytarabine IV continuously over 96 hours, daunorubicin hydrochloride IV continuously, and oral thioguanine BID on days 1-4. COURSE II: Patients receive high-dose cytarabine IV over 3 hours BID on days 1, 2, 8, and 9 and asparaginase (IM) on days 2 and 9. COURSE III: Patients receive treatment as in course I. COURSE IV: Patients receive cytarabine IV, daunorubicin hydrochloride IV, and oral thioguanine as in course I INTENSIFICATION THERAPY: Patients receive cytarabine IV continuously over 168 hours on days 1-7 and etoposide IV over 1 hour on days 1-3. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. asparaginase: Given IM daunorubicin hydrochloride: Given IV cytarabine: Given IV or IT thioguanine: Given orally etoposide: Given IV laboratory biomarker analysis: Correlative studies |
Measure Participants | 204 |
Number [Proportion of participants] |
0.911765
0.4%
|
Title | Prevalence of Leukemia Phenotype of DS Patients < 4 Years of Age at Diagnosis by Flow Cytometry |
---|---|
Description | Proportion of participants having megakaryoblastic subtype (AMkL) phenotype among patients with phenotype data available. |
Time Frame | At the start of therapy |
Outcome Measure Data
Analysis Population Description |
---|
Ineligible patients (n=1) are excluded. Patients without available or evaluable phenotype data are excluded (n=40). Data are not available at end of therapy or relapse. |
Arm/Group Title | Treatment (Combination Chemotherapy) |
---|---|
Arm/Group Description | INDUCTION THERAPY COURSE I: Patients receive cytarabine IT on day 1 and cytarabine IV continuously over 96 hours, daunorubicin hydrochloride IV continuously, and oral thioguanine BID on days 1-4. COURSE II: Patients receive high-dose cytarabine IV over 3 hours BID on days 1, 2, 8, and 9 and asparaginase (IM) on days 2 and 9. COURSE III: Patients receive treatment as in course I. COURSE IV: Patients receive cytarabine IV, daunorubicin hydrochloride IV, and oral thioguanine as in course I INTENSIFICATION THERAPY: Patients receive cytarabine IV continuously over 168 hours on days 1-7 and etoposide IV over 1 hour on days 1-3. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. asparaginase: Given IM daunorubicin hydrochloride: Given IV cytarabine: Given IV or IT thioguanine: Given orally etoposide: Given IV laboratory biomarker analysis: Correlative studies |
Measure Participants | 164 |
Number [Proportion of participants] |
0.45122
0.2%
|
Title | Prevalence of of GATA1 Mutations of DS Patients < 4 Years of Age at Diagnosis |
---|---|
Description | Proportion of participants having GATA1 mutation among patients with phenotype data available. |
Time Frame | At baseline and at the end of therapy (intensification) or disease relapse |
Outcome Measure Data
Analysis Population Description |
---|
Ineligible patients (n=1) are excluded. Patients without available or evaluable phenotype data are excluded (n=158). Data are not available at end of therapy or relapse. |
Arm/Group Title | Treatment (Combination Chemotherapy) |
---|---|
Arm/Group Description | INDUCTION THERAPY COURSE I: Patients receive cytarabine IT on day 1 and cytarabine IV continuously over 96 hours, daunorubicin hydrochloride IV continuously, and oral thioguanine BID on days 1-4. COURSE II: Patients receive high-dose cytarabine IV over 3 hours BID on days 1, 2, 8, and 9 and asparaginase (IM) on days 2 and 9. COURSE III: Patients receive treatment as in course I. COURSE IV: Patients receive cytarabine IV, daunorubicin hydrochloride IV, and oral thioguanine as in course I INTENSIFICATION THERAPY: Patients receive cytarabine IV continuously over 168 hours on days 1-7 and etoposide IV over 1 hour on days 1-3. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. asparaginase: Given IM daunorubicin hydrochloride: Given IV cytarabine: Given IV or IT thioguanine: Given orally etoposide: Given IV laboratory biomarker analysis: Correlative studies |
Measure Participants | 46 |
Number [Proportion of participants] |
0.891304
0.4%
|
Title | Proportions of Patients in Morphologic Remission With Positive MRD by Flow Cytometry |
---|---|
Description | Proportion of participants in complete remission by morphology and with positive MRD by flow cytometry among patients having evaluable remission and MRD assessment. |
Time Frame | After Induction I therapy (day 28 from start of therapy) |
Outcome Measure Data
Analysis Population Description |
---|
Ineligible patients (n=1) are excluded. Patients without available MRD at end of Induction I (n=58) or not evaluable for morphologic remission assessment (n=7) are excluded. MRD data are not available at end of Induction IV or after completion of Intensification therapy. |
Arm/Group Title | Treatment (Combination Chemotherapy) |
---|---|
Arm/Group Description | INDUCTION THERAPY COURSE I: Patients receive cytarabine IT on day 1 and cytarabine IV continuously over 96 hours, daunorubicin hydrochloride IV continuously, and oral thioguanine BID on days 1-4. COURSE II: Patients receive high-dose cytarabine IV over 3 hours BID on days 1, 2, 8, and 9 and asparaginase (IM) on days 2 and 9. COURSE III: Patients receive treatment as in course I. COURSE IV: Patients receive cytarabine IV, daunorubicin hydrochloride IV, and oral thioguanine as in course I INTENSIFICATION THERAPY: Patients receive cytarabine IV continuously over 168 hours on days 1-7 and etoposide IV over 1 hour on days 1-3. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. asparaginase: Given IM daunorubicin hydrochloride: Given IV cytarabine: Given IV or IT thioguanine: Given orally etoposide: Given IV laboratory biomarker analysis: Correlative studies |
Measure Participants | 139 |
Number [Proportion of participants] |
0.0935254
0%
|
Title | Cytarabine Drug Sensitivity by R-Strip (MicroMath) Curve Fitting Program |
---|---|
Description | Mean and standard deviation of peak plasma concentration. Specimen draws were performed only with dose 1, day 1 of induction II of AraC. First sample drawn pre-infusion, then drawn 30 mins prior to the end of the infusion, and then drawn for 6 time periods post infusion up to 8 hours post infusion (and before the 2nd dose of AraC). Results are based from these multiple time points on Day 1 of Induction II only. |
Time Frame | Days 1, 2, 8, and 9 of induction II |
Outcome Measure Data
Analysis Population Description |
---|
Ineligible patients (n=1) are excluded. Patients without available data from peak plasma concentration (n=146) are excluded. |
Arm/Group Title | Treatment (Combination Chemotherapy) |
---|---|
Arm/Group Description | INDUCTION THERAPY COURSE I: Patients receive cytarabine IT on day 1 and cytarabine IV continuously over 96 hours, daunorubicin hydrochloride IV continuously, and oral thioguanine BID on days 1-4. COURSE II: Patients receive high-dose cytarabine IV over 3 hours BID on days 1, 2, 8, and 9 and asparaginase (IM) on days 2 and 9. COURSE III: Patients receive treatment as in course I. COURSE IV: Patients receive cytarabine IV, daunorubicin hydrochloride IV, and oral thioguanine as in course I INTENSIFICATION THERAPY: Patients receive cytarabine IV continuously over 168 hours on days 1-7 and etoposide IV over 1 hour on days 1-3. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. asparaginase: Given IM daunorubicin hydrochloride: Given IV cytarabine: Given IV or IT thioguanine: Given orally etoposide: Given IV laboratory biomarker analysis: Correlative studies |
Measure Participants | 58 |
Mean (Standard Deviation) [Mean micromolar] |
32.69931
(18.545798)
|
Title | Cytarabine Drug Sensitivity by R-Strip (MicroMath) Curve Fitting Program |
---|---|
Description | Mean and standard deviation of area under the concentration time curve. Specimen draws were performed only with dose 1, day 1 of induction II of AraC. First sample drawn pre-infusion, then drawn 30 mins prior to the end of the infusion, and then drawn for 6 time periods post infusion up to 8 hours post infusion (and before the 2nd dose of AraC). Results are based from these multiple time points on Day 1 of Induction II only. |
Time Frame | Days 1, 2, 8, and 9 of induction II |
Outcome Measure Data
Analysis Population Description |
---|
Ineligible patients (n=1) are excluded. Patients without available data for area under the concentration time curve (n=146) are excluded. |
Arm/Group Title | Treatment (Combination Chemotherapy) |
---|---|
Arm/Group Description | INDUCTION THERAPY COURSE I: Patients receive cytarabine IT on day 1 and cytarabine IV continuously over 96 hours, daunorubicin hydrochloride IV continuously, and oral thioguanine BID on days 1-4. COURSE II: Patients receive high-dose cytarabine IV over 3 hours BID on days 1, 2, 8, and 9 and asparaginase (IM) on days 2 and 9. COURSE III: Patients receive treatment as in course I. COURSE IV: Patients receive cytarabine IV, daunorubicin hydrochloride IV, and oral thioguanine as in course I INTENSIFICATION THERAPY: Patients receive cytarabine IV continuously over 168 hours on days 1-7 and etoposide IV over 1 hour on days 1-3. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. asparaginase: Given IM daunorubicin hydrochloride: Given IV cytarabine: Given IV or IT thioguanine: Given orally etoposide: Given IV laboratory biomarker analysis: Correlative studies |
Measure Participants | 58 |
Mean (Standard Deviation) [Mean micromolar x minutes] |
1337.279
(1172.20853)
|
Title | Cytarabine Drug Sensitivity by R-Strip (MicroMath) Curve Fitting Program |
---|---|
Description | Mean and standard deviation of half-life of elimination. Specimen draws were performed only with dose 1, day 1 of induction II of AraC. First sample drawn pre-infusion, then drawn 30 mins prior to the end of the infusion, and then drawn for 6 time periods post infusion up to 8 hours post infusion (and before the 2nd dose of AraC). Results are based from these multiple time points on Day 1 of Induction II only. |
Time Frame | Days 1, 2, 8, and 9 of induction II |
Outcome Measure Data
Analysis Population Description |
---|
Ineligible patients (n=1) are excluded. Patients without available data for half-life of elimination (n=146) are excluded. |
Arm/Group Title | Treatment (Combination Chemotherapy) |
---|---|
Arm/Group Description | INDUCTION THERAPY COURSE I: Patients receive cytarabine IT on day 1 and cytarabine IV continuously over 96 hours, daunorubicin hydrochloride IV continuously, and oral thioguanine BID on days 1-4. COURSE II: Patients receive high-dose cytarabine IV over 3 hours BID on days 1, 2, 8, and 9 and asparaginase (IM) on days 2 and 9. COURSE III: Patients receive treatment as in course I. COURSE IV: Patients receive cytarabine IV, daunorubicin hydrochloride IV, and oral thioguanine as in course I INTENSIFICATION THERAPY: Patients receive cytarabine IV continuously over 168 hours on days 1-7 and etoposide IV over 1 hour on days 1-3. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. asparaginase: Given IM daunorubicin hydrochloride: Given IV cytarabine: Given IV or IT thioguanine: Given orally etoposide: Given IV laboratory biomarker analysis: Correlative studies |
Measure Participants | 58 |
Mean (Standard Deviation) [Mean minutes] |
306.156034
(307.042662)
|
Title | Gene Expression Profiles by Microarrays |
---|---|
Description | A hierarchical clustering algorithm is used to assemble the genes into a dendrogram or tree structure with branches containing genes with similar patterns of expression. This ordered representation can be graphically displayed with colors that reflect the qualitative and quantitative relationships of the expressed genes. |
Time Frame | At baseline and at the time of relapse (if available) |
Outcome Measure Data
Analysis Population Description |
---|
The Microarray analysis secondary outcome is not available because the number of specimens with good quality wasn't sufficient to yield meaningful results. |
Arm/Group Title | Treatment (Combination Chemotherapy) |
---|---|
Arm/Group Description | INDUCTION THERAPY COURSE I: Patients receive cytarabine IT on day 1 and cytarabine IV continuously over 96 hours, daunorubicin hydrochloride IV continuously, and oral thioguanine BID on days 1-4. COURSE II: Patients receive high-dose cytarabine IV over 3 hours BID on days 1, 2, 8, and 9 and asparaginase (IM) on days 2 and 9. COURSE III: Patients receive treatment as in course I. COURSE IV: Patients receive cytarabine IV, daunorubicin hydrochloride IV, and oral thioguanine as in course I INTENSIFICATION THERAPY: Patients receive cytarabine IV continuously over 168 hours on days 1-7 and etoposide IV over 1 hour on days 1-3. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. asparaginase: Given IM daunorubicin hydrochloride: Given IV cytarabine: Given IV or IT thioguanine: Given orally etoposide: Given IV laboratory biomarker analysis: Correlative studies |
Measure Participants | 0 |
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. | |
Arm/Group Title | Treatment (Combination Chemotherapy) | |
Arm/Group Description | INDUCTION THERAPY COURSE I: Patients receive cytarabine IT on day 1 and cytarabine IV continuously over 96 hours, daunorubicin hydrochloride IV continuously, and oral thioguanine BID on days 1-4. COURSE II: Patients receive high-dose cytarabine IV over 3 hours BID on days 1, 2, 8, and 9 and asparaginase (IM) on days 2 and 9. COURSE III: Patients receive treatment as in course I. COURSE IV: Patients receive cytarabine IV, daunorubicin hydrochloride IV, and oral thioguanine as in course I INTENSIFICATION THERAPY: Patients receive cytarabine IV continuously over 168 hours on days 1-7 and etoposide IV over 1 hour on days 1-3. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. asparaginase: Given IM daunorubicin hydrochloride: Given IV cytarabine: Given IV or IT thioguanine: Given orally etoposide: Given IV laboratory biomarker analysis: Correlative studies | |
All Cause Mortality |
||
Treatment (Combination Chemotherapy) | ||
Affected / at Risk (%) | # Events | |
Total | / (NaN) | |
Serious Adverse Events |
||
Treatment (Combination Chemotherapy) | ||
Affected / at Risk (%) | # Events | |
Total | 3/204 (1.5%) | |
Gastrointestinal disorders | ||
Ascites | 1/204 (0.5%) | |
Typhlitis | 1/204 (0.5%) | |
Hepatobiliary disorders | ||
Hepatic failure | 1/204 (0.5%) | |
Immune system disorders | ||
Immune system disorders - Other | 1/204 (0.5%) | |
Respiratory, thoracic and mediastinal disorders | ||
Hypoxia | 1/204 (0.5%) | |
Respiratory, thoracic and mediastinal disorders - Other | 1/204 (0.5%) | |
Other (Not Including Serious) Adverse Events |
||
Treatment (Combination Chemotherapy) | ||
Affected / at Risk (%) | # Events | |
Total | 185/204 (90.7%) | |
Blood and lymphatic system disorders | ||
Anemia | 2/204 (1%) | |
Blood and lymphatic system disorders - Other | 1/204 (0.5%) | |
Disseminated intravascular coagulation | 1/204 (0.5%) | |
Febrile neutropenia | 105/204 (51.5%) | |
Cardiac disorders | ||
Cardiac arrest | 1/204 (0.5%) | |
Cardiac disorders - Other | 4/204 (2%) | |
Pericardial effusion | 2/204 (1%) | |
Sinus tachycardia | 2/204 (1%) | |
Eye disorders | ||
Photophobia | 1/204 (0.5%) | |
Gastrointestinal disorders | ||
Abdominal pain | 2/204 (1%) | |
Anal pain | 1/204 (0.5%) | |
Colitis | 4/204 (2%) | |
Diarrhea | 18/204 (8.8%) | |
Dysphagia | 1/204 (0.5%) | |
Esophagitis | 1/204 (0.5%) | |
Gastritis | 1/204 (0.5%) | |
Gastrointestinal disorders - Other | 1/204 (0.5%) | |
Malabsorption | 1/204 (0.5%) | |
Mucositis oral | 20/204 (9.8%) | |
Nausea | 1/204 (0.5%) | |
Oral hemorrhage | 1/204 (0.5%) | |
Oral pain | 5/204 (2.5%) | |
Typhlitis | 2/204 (1%) | |
Upper gastrointestinal hemorrhage | 1/204 (0.5%) | |
Vomiting | 8/204 (3.9%) | |
General disorders | ||
Fatigue | 1/204 (0.5%) | |
Fever | 7/204 (3.4%) | |
Irritability | 1/204 (0.5%) | |
Pain | 6/204 (2.9%) | |
Immune system disorders | ||
Anaphylaxis | 5/204 (2.5%) | |
Infections and infestations | ||
Anorectal infection | 1/204 (0.5%) | |
Bladder infection | 1/204 (0.5%) | |
Catheter related infection | 22/204 (10.8%) | |
Conjunctivitis infective | 1/204 (0.5%) | |
Device related infection | 1/204 (0.5%) | |
Endocarditis infective | 1/204 (0.5%) | |
Enterocolitis infectious | 13/204 (6.4%) | |
Eye infection | 1/204 (0.5%) | |
Gum infection | 1/204 (0.5%) | |
Infections and infestations - Other | 122/204 (59.8%) | |
Lung infection | 12/204 (5.9%) | |
Otitis externa | 1/204 (0.5%) | |
Otitis media | 2/204 (1%) | |
Sepsis | 8/204 (3.9%) | |
Sinusitis | 1/204 (0.5%) | |
Skin infection | 7/204 (3.4%) | |
Small intestine infection | 2/204 (1%) | |
Soft tissue infection | 2/204 (1%) | |
Upper respiratory infection | 11/204 (5.4%) | |
Urinary tract infection | 6/204 (2.9%) | |
Vulval infection | 1/204 (0.5%) | |
Injury, poisoning and procedural complications | ||
Vascular access complication | 1/204 (0.5%) | |
Investigations | ||
Activated partial thromboplastin time prolonged | 2/204 (1%) | |
Alanine aminotransferase increased | 23/204 (11.3%) | |
Aspartate aminotransferase increased | 9/204 (4.4%) | |
Blood bilirubin increased | 1/204 (0.5%) | |
Electrocardiogram QT corrected interval prolonged | 4/204 (2%) | |
GGT increased | 3/204 (1.5%) | |
Investigations - Other | 1/204 (0.5%) | |
Lipase increased | 2/204 (1%) | |
Lymphocyte count decreased | 2/204 (1%) | |
Neutrophil count decreased | 13/204 (6.4%) | |
Platelet count decreased | 4/204 (2%) | |
Serum amylase increased | 1/204 (0.5%) | |
Weight loss | 1/204 (0.5%) | |
White blood cell decreased | 5/204 (2.5%) | |
Metabolism and nutrition disorders | ||
Acidosis | 4/204 (2%) | |
Alkalosis | 1/204 (0.5%) | |
Anorexia | 24/204 (11.8%) | |
Dehydration | 4/204 (2%) | |
Hyperglycemia | 13/204 (6.4%) | |
Hyperkalemia | 8/204 (3.9%) | |
Hypoalbuminemia | 3/204 (1.5%) | |
Hypocalcemia | 11/204 (5.4%) | |
Hypoglycemia | 2/204 (1%) | |
Hypokalemia | 17/204 (8.3%) | |
Hypomagnesemia | 1/204 (0.5%) | |
Hyponatremia | 7/204 (3.4%) | |
Hypophosphatemia | 5/204 (2.5%) | |
Metabolism and nutrition disorders - Other | 1/204 (0.5%) | |
Nervous system disorders | ||
Encephalopathy | 1/204 (0.5%) | |
Nervous system disorders - Other | 1/204 (0.5%) | |
Seizure | 1/204 (0.5%) | |
Renal and urinary disorders | ||
Acute kidney injury | 1/204 (0.5%) | |
Respiratory, thoracic and mediastinal disorders | ||
Adult respiratory distress syndrome | 2/204 (1%) | |
Apnea | 1/204 (0.5%) | |
Aspiration | 2/204 (1%) | |
Dyspnea | 1/204 (0.5%) | |
Epistaxis | 2/204 (1%) | |
Hypoxia | 21/204 (10.3%) | |
Laryngeal edema | 1/204 (0.5%) | |
Pharyngeal mucositis | 1/204 (0.5%) | |
Pleural effusion | 2/204 (1%) | |
Pneumonitis | 2/204 (1%) | |
Respiratory, thoracic and mediastinal disorders - Other | 1/204 (0.5%) | |
Stridor | 1/204 (0.5%) | |
Skin and subcutaneous tissue disorders | ||
Pain of skin | 1/204 (0.5%) | |
Purpura | 1/204 (0.5%) | |
Rash maculo-papular | 3/204 (1.5%) | |
Vascular disorders | ||
Hypertension | 1/204 (0.5%) | |
Hypotension | 8/204 (3.9%) |
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 |
resultsreportingcoordintator@childrensoncologygroup.org |
- AAML0431
- NCI-2009-00318
- CDR0000492776
- COG-AAML0431
- AAML0431
- U10CA098543