- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00057811
Rituximab, Rasburicase, and Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Advanced B-Cell Leukemia or Lymphoma
A Pilot Study To Determine The Toxicity Of The Addition Of Rituximab To The Induction And Consolidation Phases And The Addition Of Rasburicase To The Reduction Phase In Children With Newly Diagnosed Advanced B-Cell Leukemia/Lymphoma Treated With LMB/FAB Therapy
Study Overview
Status
Conditions
- Childhood Diffuse Large Cell Lymphoma
- Childhood Immunoblastic Large Cell Lymphoma
- Childhood Burkitt Lymphoma
- Untreated Childhood Acute Lymphoblastic Leukemia
- Stage I Childhood Large Cell Lymphoma
- Stage I Childhood Small Noncleaved Cell Lymphoma
- Stage II Childhood Large Cell Lymphoma
- Stage II Childhood Small Noncleaved Cell Lymphoma
- Stage III Childhood Large Cell Lymphoma
- Stage III Childhood Small Noncleaved Cell Lymphoma
- Stage IV Childhood Large Cell Lymphoma
- Stage IV Childhood Small Noncleaved Cell Lymphoma
Intervention / Treatment
- Other: laboratory biomarker analysis
- Drug: cyclophosphamide
- Drug: methylprednisolone
- Biological: rituximab
- Drug: etoposide
- Drug: vincristine sulfate
- Drug: cytarabine
- Drug: leucovorin calcium
- Biological: filgrastim
- Drug: doxorubicin hydrochloride
- Drug: methotrexate
- Drug: rasburicase
- Drug: prednisone
- Drug: hydrocortisone sodium succinate
Detailed Description
OBJECTIVES:
I. Determine the toxicity of the addition of rituximab to induction chemotherapy comprising vincristine, methylprednisolone, methotrexate, leucovorin calcium, cyclophosphamide, and doxorubicin (COPADM) [COMRAP] and to consolidation chemotherapy in children with newly diagnosed FAB prognostic group B or group C leukemia or lymphoma treated with LMB/FAB therapy.
II. Determine the toxicity of the addition of rasburicase to the reduction phase comprising cyclophosphamide, vincristine, prednisone or methylprednisolone, methotrexate, and leucovorin calcium (COP-R) in these patients.
III. Determine the incidence of tumor lysis syndrome, renal complications, and the use of assisted renal support (i.e., dialysis or hemofiltration) during the COP-R reduction phase and the first induction phase of COPADM or COMRAP in these patients.
IV. Determine the response rate of patients treated with COMRAP incorporated into LMB/FAB therapy.
V. Assess minimal residual disease in patients before and during COMRAP therapy incorporated into LMB/FAB therapy.
OUTLINE: This is a multicenter study. Patients are stratified according to FAB prognostic group (B vs C) and treated by group classification.
FAB GROUP B
TREATMENT I (first 6 patients):
REDUCTION THERAPY: Patients receive the COP-R regimen comprising cyclophosphamide IV over 15 minutes, vincristine IV, and methotrexate and hydrocortisone intrathecally (IT) on day 0; rasburicase* IV over 30 minutes every 12 hours on days 0 and 1 and then once daily on days 2-4 (patients exhibiting hyperuricemia and clinical suspicion of B-cell non-Hodgkin's lymphoma or B-cell acute lymphocytic leukemia also receive rasburicase on days -3, -2, and -1); leucovorin calcium IV or orally every 12 hours on days 1 and 3; and prednisone (PRED) or methylprednisolone (MePRDL) IV (or orally) on days 0-6. Patients too critical to proceed may receive another course of reduction therapy.
NOTE: *Patients with G6PD deficiency do not receive rasburicase during reduction therapy.
INDUCTION THERAPY: Patients with less than 20% tumor reduction follow the group C induction phase (described below). Patients with at least 20% tumor reduction receive 1 course of the COPADM regimen: vincristine IV and methotrexate IV over 4 hours on day 0; PRED or MePRDL IV (or orally) on days 0-7; leucovorin calcium IV or orally every 6 hours for 12 doses on days 1-3; doxorubicin IV over 30-60 minutes on day 1; cyclophosphamide IV over 15 minutes every 12 hours on days 1-3; methotrexate IT and hydrocortisone IT on days 1 and 5; and filgrastim (G-CSF) subcutaneously (SC) beginning on day 6 and continuing until blood counts recover.
Patients receive the second part of induction therapy when peripheral blood counts have recovered but no fewer than 16 days after the first part of induction therapy. Patients receive 1 course of the COMRAP regimen comprising rituximab IV on days -2 and 0 with COPADM as in the first part of induction therapy.
CONSOLIDATION THERAPY: Patients receive the CYM-RM regimen comprising rituximab IV and methotrexate IV over 4 hours on day 0; leucovorin calcium IV or orally every 6 hours for 12 doses on days 1-3; cytarabine IV over 24 hours daily on days 1-5; hydrocortisone IT on days 1 and 6; methotrexate IT on day 1; and cytarabine IT on day 6.
After full recovery from consolidation therapy, patients with any residual masses undergo surgical excision or biopsy. Patients with histology positive for tumor (even if completely resected) proceed to Group C consolidation therapy (described below). Patients with histology negative for tumor proceed to Group B maintenance therapy.
MAINTENANCE THERAPY: Patients receive the COPADM regimen comprising vincristine IV and methotrexate IV over 4 hours on day 0; PRED or MePRDL IV (or orally) on days 0-7; doxorubicin IV over 30-60 minutes, and cyclophosphamide IV over 30 minutes on days 1 and 2; methotrexate IT and hydrocortisone IT on day 1; and leucovorin calcium IV or orally every 6 hours on days 1-3 (12 doses).
TREATMENT II (44 patients):
REDUCTION THERAPY: Patients receive the COP-R regimen as in treatment I.
INDUCTION THERAPY: Patients receive 2 courses of the COMRAP regimen as in the second induction of treatment I.
CONSOLIDATION THERAPY: Patients receive the CYM-RM regimen as in treatment I.
MAINTENANCE THERAPY: Patients receive the COPADM regimen as in treatment I.
FAB GROUP C:
TREATMENT I (first 3 patients):
REDUCTION THERAPY: Patients receive the COP-R regimen as in group B treatment I, with the addition of triple intrathecal therapy (TIT) comprising methotrexate, hydrocortisone, and cytarabine on days 0, 2, and 4.
INDUCTION THERAPY: Patients receive 2 courses of the COPADM regimen as in group B treatment I, with the addition of TIT on days 1, 3, and 5. Patients in group C who have biopsy-proven disease after induction therapy are off protocol therapy and treated at the discretion of the investigator.
CONSOLIDATION THERAPY:
CNS-POSITIVE DISEASE: Patients receive 2 courses of the CYVE-RM regimen comprising rituximab IV and methotrexate and hydrocortisone IT on day 0; cytarabine IV over 12 hours on days 0-4; high-dose cytarabine IV over 3 hours and etoposide IV over 2 hours on days 1-4; and G-CSF SC on days 6-20. During the first course, patients also receive HD-MTX IV over 4 hours on day 17; TIT on day 18; and leucovorin calcium IV or orally every 6 hours on days 18-21 (12 doses).
CNS-NEGATIVE DISEASE: Patients receive the CYVE-RM regimen without intrathecal therapy, HD-MTX, or leucovorin calcium.
After full recovery from consolidation therapy, patients with any residual masses undergo surgical excision or biopsy. Patients who do not achieve complete remission after consolidation therapy are considered treatment failures.
MAINTENANCE THERAPY (each course lasts 28 days):
COURSE M1: Patients receive vincristine IV and high-dose methotrexate IV over 4 hours on day 0; PRED or MePRDL IV (or orally) on days 0-7; doxorubicin IV over 30-60 minutes and TIT on day 1; cyclophosphamide IV over 30 minutes on days 1 and 2; and leucovorin calcium IV or orally every 6 hours on days 1-4 (12 doses).
COURSE M2: Patients receive etoposide IV over 90 minutes on days 0-2 and cytarabine SC every 12 hours on days 0-4.
COURSE M3: Patients receive vincristine IV on day 0; cyclophosphamide IV over 30 minutes on days 0 and 1; PRED or MePRDL IV (or orally) twice daily on days 0-7; and doxorubicin IV over 30-60 minutes on day 0 (after first dose of cyclophosphamide).
COURSE M4: Patients receive etoposide and cytarabine as in course M2.
TREATMENT II (37 patients):
REDUCTION THERAPY: Patients receive 2 courses of the COP-R regimen as in group C treatment I.
INDUCTION THERAPY: Patients receive the COMRAP regimen comprising rituximab IV, vincristine IV, and HD-MTX IV over 4 hours on day 0; PRED or MePRDL IV (or orally) on days 0-7; leucovorin calcium IV or orally and cyclophosphamide IV over 15 minutes on days 1-3; doxorubicin IV over 30-60 minutes on day 1; TIT on days 1, 3, and 5; and G-CSF SC on days 6-20.
CONSOLIDATION THERAPY: CNS-positive disease: Patients receive the CYVE-RM regimen plus HD-MTX as in group C treatment I. Patients then receive CYVE-RM for a second course.
CNS-NEGATIVE DISEASE: Patients receive CYVE-RM regimen as in group C treatment I.
MAINTENANCE THERAPY: Patients receive maintenance therapy as in group C treatment I.
Patients are followed every 3-6 months for 1 year and then every 6 months for up to 5 years
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
California
-
Arcadia, California, United States, 91006-3776
- Children's Oncology Group
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Newly diagnosed mature B-lineage (CD20-positive) leukemia or lymphoma by the REAL classification of 1 of the following subtypes:
- Diffuse large cell lymphoma
- Burkitt's lymphoma
- High-grade B-cell lymphoma (Burkitt-like)
- No B-cell anaplastic large cell Ki-1 positive lymphomas and B-lymphoblastic lymphomas
One of the following FAB prognostic groups:
- Group B (intermediate risk)
Group C (high risk)
Bone marrow involvement with at least 25% blasts and/or CNS involvement meeting 1 or more of the following criteria:
- Any L3 blasts in cerebrospinal fluid
- Cranial nerve palsy (if not explained by extracranial tumor)
- Clinical spinal cord compression
- Isolated intracerebral mass
- Parameningeal extension (cranial and/or spinal)
- Hepatitis B status known
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 6 months after study participation
- No known history of congenital immune deficiency and/or laboratory evidence of acquired immune deficiency
- No known G6PD deficiency (if receiving rasburicase)
- No prior malignancies treated with systemic chemotherapy with alkylator or anthracycline therapy
- No prior chemotherapy
- At least 1 week since prior steroids except emergency steroids initiated within 72 hours of study entry
- No prior radiotherapy except emergency radiotherapy initiated within 72 hours of study entry
- No concurrent radiotherapy
- No prior solid organ transplantation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group B (chemotherapy, protective therapy, monoclonal antib.)
Therapies given IV, IT, orally, or SC.
Please see treatment outline.
See Detailed Description.
|
Correlative studies
Given IV
Other Names:
Given IV or orally
Other Names:
Given IV
Other Names:
Given IV
Other Names:
Given IT
Other Names:
Given IV or orally
Other Names:
Given subcutaneously
Other Names:
Given IV, IT, or orally
Other Names:
Given IV or IT
Other Names:
Given IV
Other Names:
Given IV or orally
Other Names:
Given IT
Other Names:
|
Experimental: Group C (Chemotherapy, monoclonal antibody therapy)
Therapies given IV, IT, orally, or subcutaneously (same as FAB B with the addition of etoposide and high-dose methotrexate).
See Detailed Description.
|
Correlative studies
Given IV
Other Names:
Given IV or orally
Other Names:
Given IV
Other Names:
Given IV
Other Names:
Given IV
Other Names:
Given IT
Other Names:
Given IV or orally
Other Names:
Given subcutaneously
Other Names:
Given IV, IT, or orally
Other Names:
Given IV or IT
Other Names:
Given IV or orally
Other Names:
Given IT
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Grade ≥ 3 Stomatitis
Time Frame: Up to 1 year
|
The incidence of grade ≥ 3 stomatitis.
Grade 3 stomatitis: Confluent ulcerations or pseudomembranes; bleeding with minor trauma.
Grade 4 stomatitis: Tissue necrosis; Significant spontaneous bleeding; life-threatening consequences
|
Up to 1 year
|
Response Rate
Time Frame: Up to 5 years
|
Response includes both complete and partial responses.
Per protocol, complete Response is defined as the complete disappearance of all clinical evidence of disease by physical examination, by imaging studies, by bone marrow biopsy (where indicated), by CNS evaluation (where indicated) and by biopsy where there is a residual abnormality on an imaging study.
Bone marrow must contain <5% blasts.
CSF WBC must be <5/μL with no blasts or lymphomatous cells present.
Partial response is defined as: at least a 50% reduction in the size of all measurable tumor areas.
Each site is to be defined by the product of the maximum length, width and depth (3 dimensions).
No lesion may progress.
No new lesion may appear.
Bone marrow must contain <5% blasts.
CSF WBC must be <5/μL with no blasts or lymphomatous cells present..
|
Up to 5 years
|
Minimal Residual Disease
Time Frame: Not Provided
|
The presence or absence of tumor cells at the end of induction assessed by studying tissue and/or blood/marrow.
Details of methods and criteria used can be found in Shiramizu at al. BJH 153:758-763, 2011 (full citation in the citation section).
|
Not Provided
|
Toxic Death
Time Frame: Up to 1 year
|
Implementation of the toxic death rate stopping rule, a death must be possibly, probably or definitely attributable to Rituximab and/or chemotherapy to be considered a toxic death.
|
Up to 1 year
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Mitchell Cairo, MD CCRP, Children's Oncology Group
Publications and helpful links
General Publications
- Shiramizu B, Goldman S, Kusao I, Agsalda M, Lynch J, Smith L, Harrison L, Morris E, Gross TG, Sanger W, Perkins S, Cairo MS. Minimal disease assessment in the treatment of children and adolescents with intermediate-risk (Stage III/IV) B-cell non-Hodgkin lymphoma: a children's oncology group report. Br J Haematol. 2011 Jun;153(6):758-63. doi: 10.1111/j.1365-2141.2011.08681.x. Epub 2011 Apr 18.
- Frazer JK, Li KJ, Galardy PJ, Perkins SL, Auperin A, Anderson JR, Pinkerton R, Buxton A, Gross TG, Michon J, Leverger G, Weinstein HJ, Harrison L, Shiramizu B, Barth MJ, Goldman SC, Patte C, Cairo MS. Excellent outcomes in children and adolescents with CNS+ Burkitt lymphoma or other mature B-NHL using only intrathecal and systemic chemoimmunotherapy: results from FAB/LMB96 and COG ANHL01P1. Br J Haematol. 2019 Apr;185(2):374-377. doi: 10.1111/bjh.15520. Epub 2018 Aug 16. No abstract available.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Virus Diseases
- Infections
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- DNA Virus Infections
- Tumor Virus Infections
- Leukemia, Lymphoid
- Epstein-Barr Virus Infections
- Herpesviridae Infections
- Lymphoma, B-Cell
- Lymphoma
- Lymphoma, Large B-Cell, Diffuse
- Leukemia
- Lymphoma, Non-Hodgkin
- Burkitt Lymphoma
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Lymphoma, Large-Cell, Immunoblastic
- Plasmablastic Lymphoma
- Leukemia, Lymphocytic, Chronic, B-Cell
- Leukemia, B-Cell
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Autonomic Agents
- Peripheral Nervous System Agents
- Antiviral Agents
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Neuroprotective Agents
- Protective Agents
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Antineoplastic Agents, Phytogenic
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Antineoplastic Agents, Immunological
- Dermatologic Agents
- Micronutrients
- Antibiotics, Antineoplastic
- Vitamins
- Reproductive Control Agents
- Antidotes
- Vitamin B Complex
- Abortifacient Agents, Nonsteroidal
- Abortifacient Agents
- Folic Acid Antagonists
- Gout Suppressants
- Prednisolone
- Methylprednisolone Acetate
- Methylprednisolone
- Methylprednisolone Hemisuccinate
- Prednisolone acetate
- Prednisolone hemisuccinate
- Prednisolone phosphate
- Cyclophosphamide
- Etoposide
- Etoposide phosphate
- Rituximab
- Leucovorin
- Levoleucovorin
- Prednisone
- Doxorubicin
- Liposomal doxorubicin
- Cytarabine
- Methotrexate
- Vincristine
- Rasburicase
- Hydrocortisone
- Hydrocortisone 17-butyrate 21-propionate
- Hydrocortisone acetate
- Hydrocortisone hemisuccinate
Other Study ID Numbers
- ANHL01P1
- U10CA098543 (U.S. NIH Grant/Contract)
- NCI-2009-00405 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- COG-ANHL01P1 (Other Identifier: Children's Oncology Group)
- CDR0000271941 (Other Identifier: Clinical Trials.gov)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Childhood Diffuse Large Cell Lymphoma
-
National Cancer Institute (NCI)TerminatedRecurrent Childhood Acute Lymphoblastic Leukemia | B-cell Childhood Acute Lymphoblastic Leukemia | Childhood Diffuse Large Cell Lymphoma | Childhood Immunoblastic Large Cell Lymphoma | Recurrent Childhood Large Cell Lymphoma | Recurrent Childhood Lymphoblastic Lymphoma | Recurrent Childhood Small... and other conditionsUnited States
-
National Cancer Institute (NCI)CompletedUnspecified Childhood Solid Tumor, Protocol Specific | Recurrent Childhood Medulloblastoma | Recurrent Childhood Acute Lymphoblastic Leukemia | Recurrent Childhood Acute Myeloid Leukemia | Leptomeningeal Metastases | Childhood Diffuse Large Cell Lymphoma | Childhood Immunoblastic Large Cell Lymphoma and other conditionsUnited States
-
Memorial Sloan Kettering Cancer CenterRecruitingLymphoma | Lymphoma, B-Cell | DLBCL - Diffuse Large B Cell Lymphoma | Large B-cell Lymphoma | Large-cell Lymphoma | Mediastinal B-Cell Diffuse Large Cell LymphomaUnited States
-
National Cancer Institute (NCI)WithdrawnDiffuse, Large B-cell Lymphoma | Lymphoma, Diffuse Large-Cell | Lymphoma, Diffuse Large-Cell B-cell | Large-Cell Lymphoma, Diffuse
-
Case Comprehensive Cancer CenterActive, not recruitingStage III Adult Diffuse Large Cell Lymphoma | Stage IV Adult Diffuse Large Cell Lymphoma | Contiguous Stage II Adult Diffuse Large Cell Lymphoma | Noncontiguous Stage II Adult Diffuse Large Cell Lymphoma | Stage I Adult Diffuse Large Cell LymphomaUnited States
-
University of NebraskaNational Cancer Institute (NCI); Genta IncorporatedTerminatedStage III Adult Diffuse Large Cell Lymphoma | Stage IV Adult Diffuse Large Cell Lymphoma | Contiguous Stage II Adult Diffuse Large Cell Lymphoma | Noncontiguous Stage II Adult Diffuse Large Cell Lymphoma | Stage I Adult Diffuse Large Cell LymphomaUnited States
-
Fox Chase Cancer CenterGenentech, Inc.WithdrawnStage III Adult Diffuse Large Cell Lymphoma | Stage IV Adult Diffuse Large Cell Lymphoma | Contiguous Stage II Adult Diffuse Large Cell Lymphoma | Noncontiguous Stage II Adult Diffuse Large Cell Lymphoma | Stage I Adult Diffuse Large Cell LymphomaUnited States
-
Roswell Park Cancer InstituteNational Cancer Institute (NCI); AmgenActive, not recruitingRecurrent Diffuse Large B-Cell Lymphoma | Refractory Diffuse Large B-Cell Lymphoma | CD20 Positive | Stage I Diffuse Large B-Cell Lymphoma | Stage II Diffuse Large B-Cell Lymphoma | Stage III Diffuse Large B-Cell Lymphoma | Stage IV Diffuse Large B-Cell LymphomaUnited States
-
National Cancer Institute (NCI)CompletedStage III Adult Diffuse Large Cell Lymphoma | Stage IV Adult Diffuse Large Cell Lymphoma | Contiguous Stage II Adult Diffuse Large Cell Lymphoma | Noncontiguous Stage II Adult Diffuse Large Cell LymphomaUnited States
-
National Cancer Institute (NCI)TerminatedStage III Adult Diffuse Large Cell Lymphoma | Stage IV Adult Diffuse Large Cell Lymphoma | Contiguous Stage II Adult Diffuse Large Cell Lymphoma | Noncontiguous Stage II Adult Diffuse Large Cell LymphomaUnited States
Clinical Trials on laboratory biomarker analysis
-
Children's Oncology GroupNational Cancer Institute (NCI)Completed
-
Alliance for Clinical Trials in OncologyNational Cancer Institute (NCI)Active, not recruitingLeukemia | Acute Lymphoblastic Leukemia | Acute Promyelocytic LeukemiaUnited States
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedUntreated Adult Acute Lymphoblastic Leukemia | Untreated Childhood Acute Lymphoblastic LeukemiaUnited States, Canada, Australia, New Zealand, Puerto Rico, Switzerland
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedChildhood Acute Lymphoblastic Leukemia in Remission | Recurrent Childhood Acute Lymphoblastic LeukemiaUnited States
-
Alliance for Clinical Trials in OncologyNational Cancer Institute (NCI)CompletedLung CancerUnited States
-
Alliance for Clinical Trials in OncologyNational Cancer Institute (NCI)Completed
-
Children's Oncology GroupNational Cancer Institute (NCI)WithdrawnClear Cell Renal Cell Carcinoma | Rhabdoid Tumor of the Kidney | Congenital Mesoblastic Nephroma | Childhood Kidney NeoplasmUnited States
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)WithdrawnBreast Carcinoma | BRCA1 Mutation Carrier | BRCA2 Mutation CarrierUnited States
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedWilms Tumor and Other Childhood Kidney TumorsUnited States
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedChildhood Acute Monoblastic Leukemia (M5a) | Childhood Acute Monocytic Leukemia (M5b) | Childhood Acute Myeloblastic Leukemia Without Maturation (M1) | Childhood Acute Myelomonocytic Leukemia (M4) | Childhood Acute Myeloid Leukemia/Other Myeloid MalignanciesUnited States