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

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ClinicalTrials.gov Identifier: NCT00075725

Recruitment Status : Unknown

Verified February 2017 by Children's Oncology Group.
Recruitment status was: Active, not recruiting

First Posted : January 13, 2004

Results First Posted : August 6, 2015

Last Update Posted : March 24, 2020

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by (Responsible Party):

Children's Oncology Group

Study Description

Brief Summary:

RATIONALE: Drugs used in chemotherapy, such as dexamethasone, prednisone, methotrexate, and leucovorin calcium (LCV), 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 or disease	Intervention/treatment	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

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Detailed Description:

OBJECTIVES:

Compare the outcome of patients with high-risk acute lymphoblastic leukemia treated with 2 different chemotherapy regimens.
Compare the relative safety and efficacy of dexamethasone vs prednisone during induction therapy in patients treated with these regimens.
Compare the relative safety and efficacy of high-dose methotrexate with leucovorin rescue vs escalating methotrexate without leucovorin rescue during interim maintenance I in patients treated with these regimens.
Correlate minimal residual disease (MRD) at day 29 with event-free survival and overall survival of patients treated with these regimens.
Correlate early marrow response status with day-29 MRD in patients treated with these regimens.
Identify additional high-risk patients for treatment with the fully augmented Berlin-Frankfurt-Munster regimen by using day-29 MRD.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to early response (slow early response (SER) vs rapid early response (RER).

Induction therapy: Patients are randomized to 1 of 4 treatment arms.
- Arm I: Patients receive intrathecal (IT) cytarabine on day 1; vincristine (VCR) IV and daunorubicin IV on days 1, 8, 15, and 22; oral or IV dexamethasone twice daily on days 1-14; IT methotrexate (MTX) on days 8 and 29*; and pegaspargase intramuscularly (IM) once on day 4, 5, or 6.

Note: *Patients with CNS3 disease (WBC > 5/mL in cerebrospinal fluid and positive for blasts on cytospin) also receive IT MTX on days 15 and 22.

Arm II: Patients receive induction therapy as in arm I.
Arm III: Patients receive cytarabine, vincristine, daunorubicin, and pegaspargase (PEG-ASP) as in arm I. Patients also receive oral or IV prednisone twice daily on days 1-28 and IT MTX on days 8 and 29.
Arm IV: Patients receive induction therapy as in arm III. Patients in all arms are evaluated at day 29 of induction therapy. Patients with M3 disease are removed from study. Patients with M1 disease and less than 1% minimal residual disease (MRD) proceed to consolidation therapy beginning on day 36. Patients with M2 disease OR with M1 disease and at least 1% MRD receive extended induction therapy for 2 additional weeks. Patients with SER disease and MLL rearrangements are removed from the study but may be eligible for treatment on protocol COG-AALL0031.
- Extended induction therapy: Patients continue to receive therapy on the arm to which they were originally randomized.
Arms I and II: Patients receive oral or IV dexamethasone twice daily on days 1-14; vincristine IV on days 1 and 8; daunorubicin IV on day 1; and pegaspargase IM on day 4, 5, or 6 and are then reevaluated.
Arms III and IV: Patients receive oral or IV prednisone twice daily on days 1-14, and vincristine, daunorubicin, and pegaspargase as in arms I and II and are then reevaluated.

Patients on all arms who have M1 disease and less than 1% MRD after extended induction proceed to consolidation therapy and continue as SER patients. All other patients are removed from study.

Consolidation therapy: All patients receive cyclophosphamide IV over 30 minutes on days 1 and 29; cytarabine IV or subcutaneously (SC) on days 1-4, 8-11, 29-32, and 36-39; oral mercaptopurine (MP) on days 1-14 and 29-42; vincristine IV on days 15, 22, 43, and 50; pegaspargase IM on days 15 and 43; and IT MTX* on days 1, 8, 15, and 22. Patients with testicular disease also receive radiotherapy to the testes.

NOTE: *Patients with CNS3 disease receive MTX on days 1 and 8 only.

Interim maintenance therapy I: Patients continue to receive treatment on the arm to which they were originally randomized.
- Arm I (escalating-dose MTX): Patients receive vincristine IV and escalating-dose MTX IV on days 1, 11, 21, 31, and 41; pegaspargase IM on days 2 and 22; and IT MTX on days 1 and 21.
- Arm II (high-dose MTX): Patients receive vincristine IV and high-dose methotrexate IV over 24 hours on days 1, 15, 29, and 43; oral MP on days 1-56; and IT MTX on days 1 and 29. Patients also receive leucovorin calcium IV every 6 hours for at least 3 doses, beginning 42 hours after start of each MTX infusion.
- Arm III (escalating-dose MTX): Patients receive interim maintenance I therapy as in arm I.
- Arm IV (high-dose MTX): Patients receive interim maintenance I therapy as in arm II.
Delayed intensification therapy I: All patients receive vincristine IV on days 1, 8, 15, 43, and 50; oral or IV dexamethasone twice daily on days 1 to 21 for patients age 1 to 12 OR on days 1-7 and 15-21 for patients age 13 and over; doxorubicin IV on days 1, 8, and 15; pegaspargase IM on day 4, 5, or 6 AND day 43; cyclophosphamide IV over 30 minutes on day 29; cytarabine IV or SC on days 30-33 and 37-40; oral thioguanine on days 29-42; and IT MTX on days 1, 29, and 36.

After delayed intensification I, SER patients proceed to interim maintenance II and delayed intensification II. RER patients proceed directly to maintenance.

Interim maintenance therapy II: All patients receive vincristine IV and MTX IV on days 1, 11, 21, 31, and 41; pegaspargase IM on days 2 and 22; and IT MTX on days 1 and 21. Patients then proceed to delayed intensification II.
Delayed intensification therapy II: All patients receive therapy as in delayed intensification I, arm I. CNS3 patients also receive radiotherapy for 3-10 days, beginning on day 29. All other SER patients, patients with MLL rearrangements, and some patients pretreated with steroids (> 48 hours within the week prior to diagnosis) receive prophylactic cranial radiotherapy (CRT) for 8 days, beginning on day 29. Patients then proceed to maintenance therapy.
Maintenance therapy: All patients receive vincristine IV on days 1, 29, and 57; oral dexamethasone twice daily on days 1-5, 29-33, and 57-61; oral MP on days 1-84; IT MTX on day 1*; and oral MTX on days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78.

NOTE: *RER (who did not undergo CRT) patients also receive IT MTX on day 29 for maintenance courses 1-4.

In all arms, maintenance therapy repeats every 12 weeks until total duration of therapy is 2 years from the start of interim maintenance I for female patients and 3 years from the start of interim maintenance I for male patients. Patients with testicular disease may receive testicular radiotherapy for 8 days during one of the first 3 courses of maintenance therapy.

Patients are followed monthly for 1 year, every 2 months for 1 year, every 3 months for 1 year, every 6 months for 1 year, and then annually thereafter.

PROJECTED ACCRUAL: A total of 2,964 patients will be accrued for this study.

Study Design

Layout table for study information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	3154 participants
Allocation:	Randomized
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	High Risk B-Precursor Acute Lymphoblastic Leukemia
Study Start Date :	December 2003
Actual Primary Completion Date :	December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Lymphocytic Leukemia Leukemia Steroids

Genetic and Rare Diseases Information Center resources: Acute Lymphoblastic Leukemia Lymphoblastic Lymphoma Childhood Acute Lymphoblastic Leukemia Lymphosarcoma

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Dexamethasone & Capizzi MTX patients<10 yrs Patients receive IT 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 & 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 & 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 & 2; IT MTX (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 & 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: Dexamethasone, High Dose (DH) MTX (non random) Patients non-randomly assigned to the DH regimen based on one (or more) of the following: (1) CNS3 status at entry, (2) testicular leukemic involvement at entry, or (3) extensive pre-treatment with steroids prior to entry. Patients receive IT 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 & 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 & 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 & 2; IT MTX (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 & 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: Dexamethasone & Capizzi MTX patients =>10 yrs Patients receive IT 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 & 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 & 2; IT MTX (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 & 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: Dexamethasone during Induction, High Dose MTX (IM)<10 Patients randomly assigned to the DH regimen based on one (or more) of the following: (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 IT 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 & 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 & 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 & 2; IT MTX (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 & 29 (CNS3 also on days 15 & 22) and 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: 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, Capizzi (PC) MTX (<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 IT MTX in weeks 2 & 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, Capizzi MTX (>= 10 yrs) 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 IT MTX in weeks 2 & 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 and High Dose (PH) MTX (< 10 yrs) Patients randomly assigned to the PH regimen receive IT 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 & 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 & 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and IT MTX 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: 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 and High Dose MTX (>=10 yrs) Patients randomly assigned to the PH regimen receive IT 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 & 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 & 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and IT MTX in weeks 2 & 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning 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: Dexamethasone, High Dose MTX (IM) >=10 yrs 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 IT 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 & 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 & 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 & 2; IT MTX (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 & 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: 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, Capizzi MTX Down Syndrome (DS) (non random) 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 IT MTX in weeks 2 & 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: 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: Dexamethasone, Capizzi MTX DS (non random) Patients receive IT 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 & 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 & 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 & 2; IT MTX (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 & High Dose MTX (non random) Patients non-randomly assigned to the PH regimen based on one (or more) of the following: (1) CNS3 status at entry, (2) testicular leukemic involvement at entry or (3) extensive pre-treatment with steroids prior to entry. Patients receive IT 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, & 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15, & 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and IT MTX in weeks 2 & 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning 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

Outcome Measures

Primary Outcome Measures :

Comparison of the Increase in Cure Rate of High Risk ALL Without Causing More Serious Side Effects Between Interventions [ Time Frame: 5 years ]
Event Free Probability.

Secondary Outcome Measures :

Correlation of Minimal Residual Disease (MRD) Positive With Overall Survival (OS) [ Time Frame: 5 Years ]
Bone marrow MRD status is defined as positive with >= 0.1 detectable leukemia cells, and negative with < 0.1 detectable leukemia cells.
Correlation of Minimal Residual Disease (MRD) Negative With Overall Survival (OS). [ Time Frame: 5 years ]
Bone marrow MRD status is defined as negative with < .01 detectable leukemia cells.
Correlation of Early Marrow Response Status With MRD Positive. [ Time Frame: Day 29 ]
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.
Correlation of Early Marrow Response Status With MRD Negative. [ Time Frame: Day 29 ]
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.
Correlation of Minimal Residual Disease (MRD) Positive With Event Free Survival (EFS) [ Time Frame: 5 years ]
Bone marrow MRD status is defined as positive with >= 0.1 detectable leukemia cells.
Correlation of Minimal Residual Disease (MRD) Negative With Event Free Survival (EFS). [ Time Frame: 5 years ]
Bone marrow MRD status is defined as negative with < 0.1 detectable leukemia cells.

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:	1 Year to 30 Years (Child, Adult)
Sexes Eligible for Study:	All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00075725

Locations

Show 213 study locations

Layout table for location information

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
Childrens Hospital Los Angeles
Los Angeles, California, United States, 90027
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048-1865
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095-1781
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
University of California Davis Cancer Center
Sacramento, California, United States, 95817
Kaiser Permanente Medical Center - Oakland
Sacramento, California, United States, 95825
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
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
Washington, District of Columbia, United States, 20007
Children's National Medical Center
Washington, District of Columbia, United States, 20010-2970
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
University of Miami Sylvester Comprehensive Cancer Center - Miami
Miami, Florida, United States, 33136
Miami Children's Hospital
Miami, Florida, United States, 33155
Baptist-South Miami Regional Cancer Program
Miami, Florida, United States, 33176
Florida Hospital Cancer Institute at Florida Hospital Orlando
Orlando, Florida, United States, 32803-1273
M.D. Anderson Cancer Center at Orlando
Orlando, Florida, United States, 32806
Nemours Children's Clinic - Orlando
Orlando, Florida, United States, 32806
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
University of Illinois Cancer Center
Chicago, Illinois, United States, 60612-7243
Rush University Medical Center
Chicago, Illinois, United States, 60612
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
Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
Baltimore, Maryland, United States, 21215
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
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
Children's Hospitals and Clinics of Minnesota - Minneapolis
Minneapolis, Minnesota, United States, 55404
Masonic Cancer Center at University of Minnesota
Minneapolis, Minnesota, United States, 55455
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
Children's Hospitals and Clinics of Minnesota - St. Paul
Saint 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
Saint Louis, Missouri, United States, 63104
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
Saint 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
Saint Peter's University Hospital
New Brunswick, New Jersey, United States, 08901
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08903
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
Brooklyn Hospital Center
Brooklyn, New York, United States, 11201-5493
Brookdale University Hospital and Medical Center
Brooklyn, New York, United States, 11212
Maimonides Cancer Center at Maimonides Medical Center
Brooklyn, New York, United States, 11219
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
NYU Cancer Institute at New York University Medical Center
New York, New York, United States, 10016
New York Weill Cornell Cancer Center at Cornell University
New York, New York, United States, 10021
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
Rainbow Babies and Children's Hospital
Cleveland, Ohio, United States, 44106-5000
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205-2696
Dayton Children's - Dayton
Dayton, Ohio, United States, 45404-1815
Toledo Hospital
Toledo, Ohio, United States, 43606
Medical University of Ohio Cancer Center
Toledo, Ohio, United States, 43614
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
Legacy Emanuel Hospital and Health Center and Children's Hospital
Portland, Oregon, United States, 97227
Knight Cancer Institute at Oregon Health and Science University
Portland, Oregon, United States, 97239-3098
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
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104-9786
St. Christopher's Hospital for Children
Philadelphia, Pennsylvania, United States, 19134-1095
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
Medical City Dallas Hospital
Dallas, Texas, United States, 75230
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, United States, 75390
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
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78207
Methodist Children's Hospital of South Texas
San Antonio, Texas, United States, 78229-3993
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

National Cancer Institute (NCI)

Investigators

Layout table for investigator information

Study Chair:	Eric C. Larsen, MD	Maine Children's Cancer Program at Barbara Bush Children's Hospital

More Information

Additional Information:

Data Available: Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

Publications of Results:

Winick NJ, Salzer WL, Devidas M, et al.: Dexamethasone (DEX) versus prednisone (PRED) during induction for children with high-risk acute lymphoblastic leukemia (HR-ALL): A report from the Children's Oncology Group Study AALL0232. [Abstract] J Clin Oncol 29 (Suppl 15): A-9504, 2011.

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.

Other Publications:

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Wood B, Wu D, Crossley B, Dai Y, Williamson D, Gawad C, Borowitz MJ, Devidas M, Maloney KW, Larsen E, Winick N, Raetz E, Carroll WL, Hunger SP, Loh ML, Robins H, Kirsch I. Measurable residual disease detection by high-throughput sequencing improves risk stratification for pediatric B-ALL. Blood. 2018 Mar 22;131(12):1350-1359. doi: 10.1182/blood-2017-09-806521. Epub 2017 Dec 28.

Karol SE, Mattano LA Jr, Yang W, Maloney KW, Smith C, Liu C, Ramsey LB, Fernandez CA, Chang TY, Neale G, Cheng C, Mardis E, Fulton R, Scheet P, San Lucas FA, Larsen EC, Loh ML, Raetz EA, Hunger SP, Devidas M, Relling MV. Genetic risk factors for the development of osteonecrosis in children under age 10 treated for acute lymphoblastic leukemia. Blood. 2016 Feb 4;127(5):558-64. doi: 10.1182/blood-2015-10-673848. Epub 2015 Nov 20.

Karol SE, Yang W, Van Driest SL, Chang TY, Kaste S, Bowton E, Basford M, Bastarache L, Roden DM, Denny JC, Larsen E, Winick N, Carroll WL, Cheng C, Pei D, Fernandez CA, Liu C, Smith C, Loh ML, Raetz EA, Hunger SP, Scheet P, Jeha S, Pui CH, Evans WE, Devidas M, Mattano LA Jr, Relling MV. Genetics of glucocorticoid-associated osteonecrosis in children with acute lymphoblastic leukemia. Blood. 2015 Oct 8;126(15):1770-6. doi: 10.1182/blood-2015-05-643601. Epub 2015 Aug 11.

Borowitz MJ, Wood BL, Devidas M, Loh ML, Raetz EA, Salzer WL, Nachman JB, Carroll AJ, Heerema NA, Gastier-Foster JM, Willman CL, Dai Y, Winick NJ, Hunger SP, Carroll WL, Larsen E. Prognostic significance of minimal residual disease in high risk B-ALL: a report from Children's Oncology Group study AALL0232. Blood. 2015 Aug 20;126(8):964-71. doi: 10.1182/blood-2015-03-633685. Epub 2015 Jun 29.

Fernandez CA, Smith C, Yang W, Daté M, Bashford D, Larsen E, Bowman WP, Liu C, Ramsey LB, Chang T, Turner V, Loh ML, Raetz EA, Winick NJ, Hunger SP, Carroll WL, Onengut-Gumuscu S, Chen WM, Concannon P, Rich SS, Scheet P, Jeha S, Pui CH, Evans WE, Devidas M, Relling MV. HLA-DRB1*07:01 is associated with a higher risk of asparaginase allergies. Blood. 2014 Aug 21;124(8):1266-76. doi: 10.1182/blood-2014-03-563742. Epub 2014 Jun 26.

Layout table for additonal information

Responsible Party:	Children's Oncology Group
ClinicalTrials.gov Identifier:	NCT00075725
Other Study ID Numbers:	AALL0232 COG-AALL0232 ( Other Identifier: Children's Oncology Group ) NCI-2009-00301 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Posted:	January 13, 2004 Key Record Dates
Results First Posted:	August 6, 2015
Last Update Posted:	March 24, 2020
Last Verified:	February 2017

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:

Layout table for MeSH terms

Leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Lymphoid Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Leucovorin Cytarabine Dexamethasone Prednisone Cyclophosphamide Doxorubicin	Liposomal doxorubicin Methotrexate Vincristine Daunorubicin Asparaginase Mercaptopurine Pegaspargase Thioguanine Levoleucovorin Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents

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