Dexamethasone Compared With Prednisone During Induction Therapy and Methotrexate With or Without Leucovorin During Maintenance Therapy in Treating Patients With Newly Diagnosed High-Risk Acute Lymphoblastic Leukemia

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT00075725
First received: January 9, 2004
Last updated: August 6, 2014
Last verified: August 2014
  Purpose

RATIONALE: Drugs used in chemotherapy, such as dexamethasone, prednisone, methotrexate, and leucovorin calcium, work in different ways to stop cancer cells from dividing so they stop growing or die. Giving more than one drug may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating acute lymphoblastic leukemia.

PURPOSE: This randomized phase III trial is studying dexamethasone to see how well it works compared to prednisone during induction therapy. This trial is also studying methotrexate and leucovorin calcium to see how well they work compared to methotrexate alone during maintenance therapy in treating patients with newly diagnosed acute lymphoblastic leukemia.


Condition Intervention Phase
Leukemia
Drug: cyclophosphamide
Drug: cytarabine
Drug: daunorubicin hydrochloride
Drug: dexamethasone
Drug: doxorubicin hydrochloride
Drug: leucovorin calcium
Drug: mercaptopurine
Drug: methotrexate
Drug: pegaspargase
Drug: prednisone
Drug: thioguanine
Drug: vincristine sulfate
Radiation: radiation therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: High Risk B-Precursor Acute Lymphoblastic Leukemia

Resource links provided by NLM:


Further study details as provided by Children's Oncology Group:

Primary Outcome Measures:
  • Comparison of the increase in cure rate of high risk ALL without causing more serious side effects between interventions [ Time Frame: During the first month of treatment ] [ Designated as safety issue: No ]
    Compared using a two-sided log rank test.


Secondary Outcome Measures:
  • Relative safety and efficacy [ Time Frame: Day 29 ] [ Designated as safety issue: Yes ]
    Relative safety and efficacy of each intervention. Adverse events (AE) are graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Compared using a two-sided log rank test.

  • Correlation of minimal residual disease (MRD) with event-free survival and overall survival [ Time Frame: Day 29 ] [ Designated as safety issue: No ]
    Bone marrow MRD status is defined as positive with >= 0.1 detectable leukemia cells, and negative with < 0.1 detectable leukemia cells.

  • Correlation of early marrow response status with MRD [ Time Frame: Day 29 ] [ Designated as safety issue: No ]
    Bone marrow status is defined as: M1: < 5% lymphoblasts; M2: 5-25% lymphoblasts; M3: > 25% lymphoblasts. Bone marrow MRD status is defined as positive with >= 0.1 detectable leukemia cells, and negative with < 0.1 detectable leukemia cells.

  • Additional high-risk patients for treatment with BFM [ Time Frame: Day 29 ] [ Designated as safety issue: No ]
    Identified using MRD


Enrollment: 3154
Study Start Date: December 2003
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Dexamethasone and Capizzi Methotrexate patients < 10 years
Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
Drug: cyclophosphamide
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
  • Cytoxan
  • NSC #2627
Drug: cytarabine
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
  • cytosine arabinoside
  • Ara-C
  • Cytosar
  • NSC #63878
Drug: daunorubicin hydrochloride
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
  • daunomycin
  • rubidomycin
  • Cerubidine
  • NSC #82151
Drug: dexamethasone
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
  • Decadron
  • Hexadrol
  • Dexone
  • Dexameth
  • NSC #34521
Drug: doxorubicin hydrochloride
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
  • Adriamycin
  • NSC #123127
Drug: leucovorin calcium
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
  • LCV
  • Wellcovorin
  • citrovorum factor
  • folinic acid
  • NSC #003590
Drug: mercaptopurine
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
  • 6-MP
  • Purinethol
  • 6-mercaptopurine
  • NSC #000755
Drug: methotrexate
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
  • MTX
  • amethopterin
  • Trexall
  • NSC #00074
Drug: pegaspargase
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
  • Peg-asparaginase
  • PEGLA
  • PEG-L-asparaginase
  • polyethylene glycol-L-asparaginase
  • Oncaspar
  • NSC 624239
Drug: thioguanine
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
  • 6-thioguanine
  • 2-amino-1
  • 7-dihydro-6H-purine-6-thione
  • WR-1141
  • Tabloid
  • Lanvis
  • NSC # 752
Drug: vincristine sulfate
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
  • Oncovin
  • VCR
  • LCR
  • NSC #67574
Radiation: radiation therapy
Patients undergo radiation therapy periodically during study treatment
Active Comparator: Dexamethasone, High Dose Methotrexate (non randomly assigned)
Patients non-randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) CNS3 status at entry, (2) testicular leukemic involvement at entry, or (3) extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
Drug: cyclophosphamide
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
  • Cytoxan
  • NSC #2627
Drug: cytarabine
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
  • cytosine arabinoside
  • Ara-C
  • Cytosar
  • NSC #63878
Drug: daunorubicin hydrochloride
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
  • daunomycin
  • rubidomycin
  • Cerubidine
  • NSC #82151
Drug: dexamethasone
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
  • Decadron
  • Hexadrol
  • Dexone
  • Dexameth
  • NSC #34521
Drug: doxorubicin hydrochloride
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
  • Adriamycin
  • NSC #123127
Drug: leucovorin calcium
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
  • LCV
  • Wellcovorin
  • citrovorum factor
  • folinic acid
  • NSC #003590
Drug: mercaptopurine
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
  • 6-MP
  • Purinethol
  • 6-mercaptopurine
  • NSC #000755
Drug: methotrexate
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
  • MTX
  • amethopterin
  • Trexall
  • NSC #00074
Drug: pegaspargase
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
  • Peg-asparaginase
  • PEGLA
  • PEG-L-asparaginase
  • polyethylene glycol-L-asparaginase
  • Oncaspar
  • NSC 624239
Drug: thioguanine
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
  • 6-thioguanine
  • 2-amino-1
  • 7-dihydro-6H-purine-6-thione
  • WR-1141
  • Tabloid
  • Lanvis
  • NSC # 752
Drug: vincristine sulfate
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
  • Oncovin
  • VCR
  • LCR
  • NSC #67574
Radiation: radiation therapy
Patients undergo radiation therapy periodically during study treatment
Active Comparator: Dexamethasone & Capizzi Methotrexate patients => 10 years old
Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
Drug: cyclophosphamide
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
  • Cytoxan
  • NSC #2627
Drug: cytarabine
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
  • cytosine arabinoside
  • Ara-C
  • Cytosar
  • NSC #63878
Drug: daunorubicin hydrochloride
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
  • daunomycin
  • rubidomycin
  • Cerubidine
  • NSC #82151
Drug: dexamethasone
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
  • Decadron
  • Hexadrol
  • Dexone
  • Dexameth
  • NSC #34521
Drug: doxorubicin hydrochloride
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
  • Adriamycin
  • NSC #123127
Drug: leucovorin calcium
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
  • LCV
  • Wellcovorin
  • citrovorum factor
  • folinic acid
  • NSC #003590
Drug: mercaptopurine
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
  • 6-MP
  • Purinethol
  • 6-mercaptopurine
  • NSC #000755
Drug: methotrexate
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
  • MTX
  • amethopterin
  • Trexall
  • NSC #00074
Drug: pegaspargase
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
  • Peg-asparaginase
  • PEGLA
  • PEG-L-asparaginase
  • polyethylene glycol-L-asparaginase
  • Oncaspar
  • NSC 624239
Drug: thioguanine
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
  • 6-thioguanine
  • 2-amino-1
  • 7-dihydro-6H-purine-6-thione
  • WR-1141
  • Tabloid
  • Lanvis
  • NSC # 752
Drug: vincristine sulfate
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
  • Oncovin
  • VCR
  • LCR
  • NSC #67574
Radiation: radiation therapy
Patients undergo radiation therapy periodically during study treatment
Active Comparator: Dexamethasone during Induction, High Dose Methotrexate (IM)
Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
Drug: cyclophosphamide
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
  • Cytoxan
  • NSC #2627
Drug: cytarabine
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
  • cytosine arabinoside
  • Ara-C
  • Cytosar
  • NSC #63878
Drug: daunorubicin hydrochloride
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
  • daunomycin
  • rubidomycin
  • Cerubidine
  • NSC #82151
Drug: dexamethasone
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
  • Decadron
  • Hexadrol
  • Dexone
  • Dexameth
  • NSC #34521
Drug: doxorubicin hydrochloride
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
  • Adriamycin
  • NSC #123127
Drug: leucovorin calcium
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
  • LCV
  • Wellcovorin
  • citrovorum factor
  • folinic acid
  • NSC #003590
Drug: mercaptopurine
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
  • 6-MP
  • Purinethol
  • 6-mercaptopurine
  • NSC #000755
Drug: methotrexate
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
  • MTX
  • amethopterin
  • Trexall
  • NSC #00074
Drug: pegaspargase
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
  • Peg-asparaginase
  • PEGLA
  • PEG-L-asparaginase
  • polyethylene glycol-L-asparaginase
  • Oncaspar
  • NSC 624239
Drug: thioguanine
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
  • 6-thioguanine
  • 2-amino-1
  • 7-dihydro-6H-purine-6-thione
  • WR-1141
  • Tabloid
  • Lanvis
  • NSC # 752
Drug: vincristine sulfate
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
  • Oncovin
  • VCR
  • LCR
  • NSC #67574
Radiation: radiation therapy
Patients undergo radiation therapy periodically during study treatment
Experimental: Prednisone, Capizzi methotrexate (<10 yrs old)
Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks
Drug: cyclophosphamide
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
  • Cytoxan
  • NSC #2627
Drug: cytarabine
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
  • cytosine arabinoside
  • Ara-C
  • Cytosar
  • NSC #63878
Drug: daunorubicin hydrochloride
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
  • daunomycin
  • rubidomycin
  • Cerubidine
  • NSC #82151
Drug: doxorubicin hydrochloride
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
  • Adriamycin
  • NSC #123127
Drug: leucovorin calcium
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
  • LCV
  • Wellcovorin
  • citrovorum factor
  • folinic acid
  • NSC #003590
Drug: mercaptopurine
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
  • 6-MP
  • Purinethol
  • 6-mercaptopurine
  • NSC #000755
Drug: methotrexate
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
  • MTX
  • amethopterin
  • Trexall
  • NSC #00074
Drug: pegaspargase
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
  • Peg-asparaginase
  • PEGLA
  • PEG-L-asparaginase
  • polyethylene glycol-L-asparaginase
  • Oncaspar
  • NSC 624239
Drug: prednisone
Given IV or orally
Other Names:
  • Deltasone
  • Meticorten
  • Orasone
  • Liquid Pred
  • Pediapred
  • Sterapred
  • NSC #010023
Drug: thioguanine
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
  • 6-thioguanine
  • 2-amino-1
  • 7-dihydro-6H-purine-6-thione
  • WR-1141
  • Tabloid
  • Lanvis
  • NSC # 752
Drug: vincristine sulfate
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
  • Oncovin
  • VCR
  • LCR
  • NSC #67574
Radiation: radiation therapy
Patients undergo radiation therapy periodically during study treatment
Experimental: Prednisone, Capezzi methotrexate (>= 10 yrs old)
Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks
Drug: cyclophosphamide
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
  • Cytoxan
  • NSC #2627
Drug: cytarabine
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
  • cytosine arabinoside
  • Ara-C
  • Cytosar
  • NSC #63878
Drug: daunorubicin hydrochloride
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
  • daunomycin
  • rubidomycin
  • Cerubidine
  • NSC #82151
Drug: doxorubicin hydrochloride
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
  • Adriamycin
  • NSC #123127
Drug: leucovorin calcium
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
  • LCV
  • Wellcovorin
  • citrovorum factor
  • folinic acid
  • NSC #003590
Drug: mercaptopurine
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
  • 6-MP
  • Purinethol
  • 6-mercaptopurine
  • NSC #000755
Drug: methotrexate
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
  • MTX
  • amethopterin
  • Trexall
  • NSC #00074
Drug: pegaspargase
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
  • Peg-asparaginase
  • PEGLA
  • PEG-L-asparaginase
  • polyethylene glycol-L-asparaginase
  • Oncaspar
  • NSC 624239
Drug: prednisone
Given IV or orally
Other Names:
  • Deltasone
  • Meticorten
  • Orasone
  • Liquid Pred
  • Pediapred
  • Sterapred
  • NSC #010023
Drug: thioguanine
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
  • 6-thioguanine
  • 2-amino-1
  • 7-dihydro-6H-purine-6-thione
  • WR-1141
  • Tabloid
  • Lanvis
  • NSC # 752
Drug: vincristine sulfate
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
  • Oncovin
  • VCR
  • LCR
  • NSC #67574
Radiation: radiation therapy
Patients undergo radiation therapy periodically during study treatment
Experimental: Predisone and High Dose Methotrexate (< 10 yrs old)
Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks
Drug: cyclophosphamide
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
  • Cytoxan
  • NSC #2627
Drug: cytarabine
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
  • cytosine arabinoside
  • Ara-C
  • Cytosar
  • NSC #63878
Drug: daunorubicin hydrochloride
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
  • daunomycin
  • rubidomycin
  • Cerubidine
  • NSC #82151
Drug: dexamethasone
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
  • Decadron
  • Hexadrol
  • Dexone
  • Dexameth
  • NSC #34521
Drug: leucovorin calcium
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
  • LCV
  • Wellcovorin
  • citrovorum factor
  • folinic acid
  • NSC #003590
Drug: mercaptopurine
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
  • 6-MP
  • Purinethol
  • 6-mercaptopurine
  • NSC #000755
Drug: methotrexate
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
  • MTX
  • amethopterin
  • Trexall
  • NSC #00074
Drug: pegaspargase
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
  • Peg-asparaginase
  • PEGLA
  • PEG-L-asparaginase
  • polyethylene glycol-L-asparaginase
  • Oncaspar
  • NSC 624239
Drug: prednisone
Given IV or orally
Other Names:
  • Deltasone
  • Meticorten
  • Orasone
  • Liquid Pred
  • Pediapred
  • Sterapred
  • NSC #010023
Experimental: Prenisone and High Dose Methotrexate (>=10 yrs old)
Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks
Drug: cyclophosphamide
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
  • Cytoxan
  • NSC #2627
Drug: cytarabine
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
  • cytosine arabinoside
  • Ara-C
  • Cytosar
  • NSC #63878
Drug: daunorubicin hydrochloride
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
  • daunomycin
  • rubidomycin
  • Cerubidine
  • NSC #82151
Drug: dexamethasone
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
  • Decadron
  • Hexadrol
  • Dexone
  • Dexameth
  • NSC #34521
Drug: leucovorin calcium
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
  • LCV
  • Wellcovorin
  • citrovorum factor
  • folinic acid
  • NSC #003590
Drug: mercaptopurine
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
  • 6-MP
  • Purinethol
  • 6-mercaptopurine
  • NSC #000755
Drug: methotrexate
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
  • MTX
  • amethopterin
  • Trexall
  • NSC #00074
Drug: pegaspargase
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
  • Peg-asparaginase
  • PEGLA
  • PEG-L-asparaginase
  • polyethylene glycol-L-asparaginase
  • Oncaspar
  • NSC 624239
Drug: prednisone
Given IV or orally
Other Names:
  • Deltasone
  • Meticorten
  • Orasone
  • Liquid Pred
  • Pediapred
  • Sterapred
  • NSC #010023

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   1 Year to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Newly diagnosed B-precursor acute lymphoblastic leukemia

    • WBC > 50,000/mm^3 for patients age 1 to 9
    • Any WBC for patients age 10 to 30 OR patients who have received prior steroid therapy OR patients with testicular disease
  • Must be eligible for and enrolled on classification study COG-AALL03B1

PATIENT CHARACTERISTICS:

Age

  • 1 to under 31

Performance status

  • Not specified

Life expectancy

  • Not specified

Hematopoietic

  • See Disease Characteristics

Hepatic

  • Not specified

Renal

  • Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • No more than 72 hours since prior intrathecal cytarabine
  • No other prior cytotoxic chemotherapy

Endocrine therapy

  • Prior steroids allowed

Radiotherapy

  • Not specified

Surgery

  • Not specified
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00075725

  Hide Study Locations
Locations
United States, Alabama
UAB Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294
University of South Alabama Mitchell Cancer Institute
Mobile, Alabama, United States, 36604
United States, Arizona
Banner Desert Medical Center
Mesa, Arizona, United States, 85202
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016-7710
Arizona Cancer Center at University of Arizona Health Sciences Center
Tucson, Arizona, United States, 85724-5024
United States, Arkansas
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
United States, California
Southern California Permanente Medical Group
Downey, California, United States, 90027
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000
Loma Linda University Cancer Institute at Loma Linda University Medical Center
Loma Linda, California, United States, 92354
Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
Long Beach, California, United States, 90801
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095-1781
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048-1865
Childrens Hospital Los Angeles
Los Angeles, California, United States, 90027
Children's Hospital Central California
Madera, California, United States, 93638-8762
Children's Hospital and Research Center Oakland
Oakland, California, United States, 94609
Children's Hospital of Orange County
Orange, California, United States, 92868
Lucile Packard Children's Hospital at Stanford University Medical Center
Palo Alto, California, United States, 95798
Kaiser Permanente Medical Center - Oakland
Sacramento, California, United States, 95825
University of California Davis Cancer Center
Sacramento, California, United States, 95817
Rady Children's Hospital - San Diego
San Diego, California, United States, 92123-4282
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94115
Santa Barbara Cottage Children's Hospital
Santa Barbara, California, United States, 93105
Kaiser Permanente Medical Center - Santa Clara Kiely Campus
Santa Clara, California, United States, 95051-5386
United States, Colorado
Children's Hospital Center for Cancer and Blood Disorders
Aurora, Colorado, United States, 80045
Presbyterian - St. Luke's Medical Center
Denver, Colorado, United States, 80218
United States, Connecticut
Connecticut Children's Medical Center
Hartford, Connecticut, United States, 06106
Yale Cancer Center
New Haven, Connecticut, United States, 06520-8028
United States, Delaware
Alfred I. duPont Hospital for Children
Wilmington, Delaware, United States, 19803
United States, District of Columbia
Children's National Medical Center
Washington, District of Columbia, United States, 20010-2970
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
Washington, District of Columbia, United States, 20007
Walter Reed Army Medical Center
Washington, District of Columbia, United States, 20307-5001
United States, Florida
Broward General Medical Center Cancer Center
Fort Lauderdale, Florida, United States, 33316
Lee Cancer Care of Lee Memorial Health System
Fort Myers, Florida, United States, 33901
University of Florida Shands Cancer Center
Gainesville, Florida, United States, 32610-0232
Memorial Cancer Institute at Memorial Regional Hospital
Hollywood, Florida, United States, 33021
Nemours Children's Clinic
Jacksonville, Florida, United States, 32207
Baptist-South Miami Regional Cancer Program
Miami, Florida, United States, 33176
Miami Children's Hospital
Miami, Florida, United States, 33155
University of Miami Sylvester Comprehensive Cancer Center - Miami
Miami, Florida, United States, 33136
M.D. Anderson Cancer Center at Orlando
Orlando, Florida, United States, 32806
Nemours Children's Clinic - Orlando
Orlando, Florida, United States, 32806
Florida Hospital Cancer Institute at Florida Hospital Orlando
Orlando, Florida, United States, 32803-1273
Sacred Heart Cancer Center at Sacred Heart Hospital
Pensacola, Florida, United States, 32504
All Children's Hospital
Saint Petersburg, Florida, United States, 33701
St. Joseph's Cancer Institute at St. Joseph's Hospital
Tampa, Florida, United States, 33607
Kaplan Cancer Center at St. Mary's Medical Center
West Palm Beach, Florida, United States, 33407
United States, Georgia
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus
Atlanta, Georgia, United States, 30322
MBCCOP - Medical College of Georgia Cancer Center
Augusta, Georgia, United States, 30912-3730
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
Savannah, Georgia, United States, 31403-3089
United States, Hawaii
Cancer Research Center of Hawaii
Honolulu, Hawaii, United States, 96813
Tripler Army Medical Center
Tripler AMC, Hawaii, United States, 96859-5000
United States, Idaho
Mountain States Tumor Institute at St. Luke's Regional Medical Center
Boise, Idaho, United States, 83712-6297
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
University of Illinois Cancer Center
Chicago, Illinois, United States, 60612-7243
Children's Memorial Hospital - Chicago
Chicago, Illinois, United States, 60614
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood, Illinois, United States, 60153
Keyser Family Cancer Center at Advocate Hope Children's Hospital
Oak Lawn, Illinois, United States, 60453
Advocate Lutheran General Cancer Care Center
Park Ridge, Illinois, United States, 60068-1174
Simmons Cooper Cancer Institute
Springfield, Illinois, United States, 62794-9677
United States, Indiana
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States, 46202-5289
St. Vincent Indianapolis Hospital
Indianapolis, Indiana, United States, 46260
United States, Iowa
Blank Children's Hospital
Des Moines, Iowa, United States, 50309
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, United States, 52242-1002
United States, Kansas
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
Kansas City, Kansas, United States, 66160-7357
United States, Kentucky
Lucille P. Markey Cancer Center at University of Kentucky
Lexington, Kentucky, United States, 40536-0093
Kosair Children's Hospital
Louisville, Kentucky, United States, 40232
United States, Louisiana
Tulane Cancer Center Office of Clinical Research
Alexandria, Louisiana, United States, 71315-3198
Children's Hospital of New Orleans
New Orleans, Louisiana, United States, 70118
United States, Maine
CancerCare of Maine at Eastern Maine Medical Center
Bangor, Maine, United States, 04401
Maine Children's Cancer Program at Barbara Bush Children's Hospital
Scarborough, Maine, United States, 04074-9308
United States, Maryland
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
Baltimore, Maryland, United States, 21215
United States, Massachusetts
Floating Hospital for Children at Tufts - New England Medical Center
Boston, Massachusetts, United States, 02111
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Baystate Regional Cancer Program at D'Amour Center for Cancer Care
Springfield, Massachusetts, United States, 01199-0001
UMASS Memorial Cancer Center - University Campus
Worcester, Massachusetts, United States, 01655
United States, Michigan
C.S. Mott Children's Hospital at University of Michigan Medical Center
Ann Arbor, Michigan, United States, 48109-0286
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
Hurley Medical Center
Flint, Michigan, United States, 48503
Butterworth Hospital at Spectrum Health
Grand Rapids, Michigan, United States, 49503-2560
Van Elslander Cancer Center at St. John Hospital and Medical Center
Grosse Pointe Woods, Michigan, United States, 48236
CCOP - Kalamazoo
Kalamazoo, Michigan, United States, 49007-5381
Breslin Cancer Center at Ingham Regional Medical Center
Lansing, Michigan, United States, 48910
William Beaumont Hospital - Royal Oak Campus
Royal Oak, Michigan, United States, 48073
United States, Minnesota
Masonic Cancer Center at University of Minnesota
Minneapolis, Minnesota, United States, 55455
Children's Hospitals and Clinics of Minnesota - Minneapolis
Minneapolis, Minnesota, United States, 55404
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
Children's Hospitals and Clinics of Minnesota - St. Paul
St. Paul, Minnesota, United States, 55102-2392
United States, Mississippi
University of Mississippi Cancer Clinic
Jackson, Mississippi, United States, 39216-4505
United States, Missouri
Ellis Fischel Cancer Center at University of Missouri - Columbia
Columbia, Missouri, United States, 65203
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
Cardinal Glennon Children's Hospital
St. Louis, Missouri, United States, 63104
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
St. Louis, Missouri, United States, 63110
United States, Nebraska
Children's Hospital
Omaha, Nebraska, United States, 68114-4113
UNMC Eppley Cancer Center at the University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-6805
United States, Nevada
CCOP - Nevada Cancer Research Foundation
Las Vegas, Nevada, United States, 89109-2306
United States, New Hampshire
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756-0002
United States, New Jersey
Hackensack University Medical Center Cancer Center
Hackensack, New Jersey, United States, 07601
St. Barnabas Medical Center Cancer Center
Livingston, New Jersey, United States, 07039
Overlook Hospital
Morristown, New Jersey, United States, 07962
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08903
Saint Peter's University Hospital
New Brunswick, New Jersey, United States, 08901
Newark Beth Israel Medical Center
Newark, New Jersey, United States, 07112
St. Joseph's Hospital and Medical Center
Paterson, New Jersey, United States, 07503
United States, New Mexico
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87131-5636
United States, New York
Albany Medical Center Hospital
Albany, New York, United States, 12208-3419
Albert Einstein Cancer Center at Albert Einstein College of Medicine
Bronx, New York, United States, 10461
Maimonides Cancer Center at Maimonides Medical Center
Brooklyn, New York, United States, 11219
Brooklyn Hospital Center
Brooklyn, New York, United States, 11201-5493
Brookdale University Hospital and Medical Center
Brooklyn, New York, United States, 11212
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Winthrop University Hospital
Mineola, New York, United States, 11501
Schneider Children's Hospital
New Hyde Park, New York, United States, 11040
New York Weill Cornell Cancer Center at Cornell University
New York, New York, United States, 10021
NYU Cancer Institute at New York University Medical Center
New York, New York, United States, 10016
Mount Sinai Medical Center
New York, New York, United States, 10029
Stony Brook University Cancer Center
Stony Brook, New York, United States, 11794-9446
SUNY Upstate Medical University Hospital
Syracuse, New York, United States, 13210
New York Medical College
Valhalla, New York, United States, 10595
United States, North Carolina
Mission Hospitals - Memorial Campus
Asheville, North Carolina, United States, 28801
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7295
Blumenthal Cancer Center at Carolinas Medical Center
Charlotte, North Carolina, United States, 28232-2861
Presbyterian Cancer Center at Presbyterian Hospital
Charlotte, North Carolina, United States, 28233-3549
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
Leo W. Jenkins Cancer Center at ECU Medical School
Greenville, North Carolina, United States, 27834
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157-1096
United States, North Dakota
CCOP - MeritCare Hospital
Fargo, North Dakota, United States, 58122
United States, Ohio
Akron Children's Hospital
Akron, Ohio, United States, 44308-1062
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229-3039
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
Rainbow Babies and Children's Hospital
Cleveland, Ohio, United States, 44106-5000
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205-2696
Dayton Children's - Dayton
Dayton, Ohio, United States, 45404-1815
Medical University of Ohio Cancer Center
Toledo, Ohio, United States, 43614
Toledo Hospital
Toledo, Ohio, United States, 43606
Tod Children's Hospital
Youngstown, Ohio, United States, 44501
United States, Oklahoma
Oklahoma University Cancer Institute
Oklahoma City, Oklahoma, United States, 73104
Natalie Warren Bryant Cancer Center at St. Francis Hospital
Tulsa, Oklahoma, United States, 74136
United States, Oregon
Knight Cancer Institute at Oregon Health and Science University
Portland, Oregon, United States, 97239-3098
Legacy Emanuel Hospital and Health Center and Children's Hospital
Portland, Oregon, United States, 97227
United States, Pennsylvania
Lehigh Valley Hospital - Muhlenberg
Bethlehem, Pennsylvania, United States, 18017
Geisinger Cancer Institute at Geisinger Health
Danville, Pennsylvania, United States, 17822-0001
Penn State Children's Hospital
Hershey, Pennsylvania, United States, 17033-0850
St. Christopher's Hospital for Children
Philadelphia, Pennsylvania, United States, 19134-1095
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104-9786
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States, 15213
United States, Rhode Island
Rhode Island Hospital Comprehensive Cancer Center
Providence, Rhode Island, United States, 02903
United States, South Carolina
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Palmetto Health South Carolina Cancer Center
Columbia, South Carolina, United States, 29203
Greenville Hospital Cancer Center
Greenville, South Carolina, United States, 29605
United States, South Dakota
Avera Cancer Institute
Sioux Falls, South Dakota, United States, 57105
Sanford Cancer Center at Sanford USD Medical Center
Sioux Falls, South Dakota, United States, 57117-5039
United States, Tennessee
T.C. Thompson Children's Hospital
Chattanooga, Tennessee, United States, 37403
East Tennessee Children's Hospital
Knoxville, Tennessee, United States, 37901
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6838
United States, Texas
Texas Tech University Health Sciences Center School of Medicine - Amarillo
Amarillo, Texas, United States, 79106
Dell Children's Medical Center of Central Texas
Austin, Texas, United States, 78723
Driscoll Children's Hospital
Corpus Christi, Texas, United States, 78411
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, United States, 75390
Medical City Dallas Hospital
Dallas, Texas, United States, 75230
Cook Children's Medical Center - Fort Worth
Fort Worth, Texas, United States, 76104
University of Texas Medical Branch
Galveston, Texas, United States, 77555-0361
Baylor University Medical Center - Houston
Houston, Texas, United States, 77030-2399
M. D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009
Covenant Children's Hospital
Lubbock, Texas, United States, 79410
Methodist Children's Hospital of South Texas
San Antonio, Texas, United States, 78229-3993
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78207
CCOP - Scott and White Hospital
Temple, Texas, United States, 76508
United States, Utah
Primary Children's Medical Center
Salt Lake City, Utah, United States, 84113-1100
United States, Vermont
Fletcher Allen Health Care - University Health Center Campus
Burlington, Vermont, United States, 05401
United States, Virginia
University of Virginia Cancer Center
Charlottesville, Virginia, United States, 22908
Inova Fairfax Hospital
Falls Church, Virginia, United States, 22042-3300
Children's Hospital of The King's Daughters
Norfolk, Virginia, United States, 23507-1971
Naval Medical Center - Portsmouth
Portsmouth, Virginia, United States, 23708-2197
Virginia Commonwealth University Massey Cancer Center
Richmond, Virginia, United States, 23298-0037
Carilion Medical Center for Children at Roanoke Community Hospital
Roanoke, Virginia, United States, 24014
United States, Washington
Children's Hospital and Regional Medical Center - Seattle
Seattle, Washington, United States, 98105
Deaconess Medical Center
Spokane, Washington, United States, 99210-0248
Providence Cancer Center at Sacred Heart Medical Center
Spokane, Washington, United States, 99220-2555
Mary Bridge Children's Hospital and Health Center - Tacoma
Tacoma, Washington, United States, 98405
Madigan Army Medical Center - Tacoma
Tacoma, Washington, United States, 98431
United States, West Virginia
West Virginia University Health Sciences Center - Charleston
Charleston, West Virginia, United States, 25302
Edwards Comprehensive Cancer Center at Cabell Huntington Hospital
Huntington, West Virginia, United States, 25701
Mary Babb Randolph Cancer Center at West Virginia University Hospitals
Morgantown, West Virginia, United States, 26506
United States, Wisconsin
St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, United States, 54307-3508
Gundersen Lutheran Center for Cancer and Blood
La Crosse, Wisconsin, United States, 54601
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792-6164
Marshfield Clinic - Marshfield Center
Marshfield, Wisconsin, United States, 54449
Midwest Children's Cancer Center at Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Australia, Queensland
Royal Children's Hospital
Brisbane, Queensland, Australia, 4029
Australia, South Australia
Women's and Children's Hospital
North Adelaide, South Australia, Australia, 5006
Australia, Victoria
Royal Children's Hospital
Parkville, Victoria, Australia, 3052
Australia, Western Australia
Princess Margaret Hospital for Children
Perth, Western Australia, Australia, 6001
Canada, Alberta
Alberta Children's Hospital
Calgary, Alberta, Canada, T3B 6A8
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
Children's & Women's Hospital of British Columbia
Vancouver, British Columbia, Canada, V6H 3V4
Canada, Manitoba
CancerCare Manitoba
Winnipeg, Manitoba, Canada, R3E 0V9
Canada, Newfoundland and Labrador
Janeway Children's Health and Rehabilitation Centre
St. John's, Newfoundland and Labrador, Canada, A1B 3V6
Canada, Nova Scotia
IWK Health Centre
Halifax, Nova Scotia, Canada, B3J 3G9
Canada, Ontario
Cancer Centre of Southeastern Ontario at Kingston General Hospital
Kingston, Ontario, Canada, K7L 2V7
Children's Hospital of Western Ontario
London, Ontario, Canada, N6A 5W9
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada, K1H 8L1
Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Canada, Saskatchewan
Allan Blair Cancer Centre at Pasqua Hospital
Regina, Saskatchewan, Canada, S4T 7T1
Saskatoon Cancer Centre at the University of Saskatchewan
Saskatoon, Saskatchewan, Canada, S7N 4H4
New Zealand
Starship Children's Health
Auckland, New Zealand, 1
Christchurch Hospital
Christchurch, New Zealand, 8140
Wellington Children's Hospital
Wellington, New Zealand, 6002
Switzerland
Swiss Pediatric Oncology Group Bern
Bern, Switzerland, 3010
Swiss Pediatric Oncology Group Geneva
Geneva, Switzerland, 1205
Swiss Pediatric Oncology Group Lausanne
Lausanne, Switzerland, 1011
Sponsors and Collaborators
Children's Oncology Group
Investigators
Study Chair: Eric C. Larsen, MD Maine Children's Cancer Program at Barbara Bush Children's Hospital
  More Information

Additional Information:
Publications:
Raetz EA, Devidas M, Carroll AJ, et al.: Cytogenetic and early-response characteristics of adolescents and young adults with acute lymphoblastic leukemia (ALL): A Children's Oncology Group (COG) study. [Abstract] J Clin Oncol 28 (Suppl 15): A-9509, 2010.
Mattano LA Jr, Nachman JB, Devidas M, et al.: Increased incidence of osteonecrosis (ON) with a dexamethasone (DEX) induction for high risk acute lymphoblastic leukemia (HR-ALL): a report from the Children's Oncology Group (COG). [Abstract] Blood 112 (11): A-898, 2008.
Bleyer A: Older adolescents and young adults with acute lymphoblastic leukemia (ALL) in the United States: from the lowest to highest death rate and number of deaths--more rationale for the CALBG-SWOG-ECOG C10403 trial based on COG AALL0232. [Abstract] J Clin Oncol 26 (Suppl 15): A-18034, 2008.
Harvey RC, Chen IM, Ar K, et al.: Identification of novel cluster groups in high-risk pediatric B-precursor acute lymphoblastic leukemia (HR-ALL) by gene expression profiling: correlation with clinical and outcome variables a Children's Oncology Group (COG) study. [Abstract] Blood 112 (11): A-2256, 2008.
Maloney KW, Larsen E, Mattano LA, et al.: Increased infection-related mortality for children with Down syndrome (DS) in contemporary Childrens Oncology Group (COG) acute lymphoblastic leukemia (ALL) clinical trials. [Abstract] Blood 108 (11): A-1865, 2006.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00075725     History of Changes
Other Study ID Numbers: AALL0232, COG-AALL0232, CDR0000349182
Study First Received: January 9, 2004
Last Updated: August 6, 2014
Health Authority: United States: Federal Government

Keywords provided by Children's Oncology Group:
untreated childhood acute lymphoblastic leukemia
B-cell childhood acute lymphoblastic leukemia
untreated adult acute lymphoblastic leukemia
B-cell adult acute lymphoblastic leukemia

Additional relevant MeSH terms:
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Leukemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cyclophosphamide
Cytarabine
Methotrexate
6-Mercaptopurine
Liposomal doxorubicin
Pegaspargase
Dexamethasone
Asparaginase
Doxorubicin
Vincristine
Prednisone
Daunorubicin
Thioguanine
Dexamethasone acetate
Dexamethasone 21-phosphate
BB 1101
Levoleucovorin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014