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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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00075725 |
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Recruitment Status :
Completed
First Posted : January 13, 2004
Results First Posted : August 6, 2015
Last Update Posted : March 21, 2017
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Sponsor:
Children's Oncology Group
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group
- Study Details
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- Study Results
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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 |
Show Detailed Description
| 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
| Arm | Intervention/treatment |
|---|---|
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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).
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Drug: cyclophosphamide
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: cytarabine Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: daunorubicin hydrochloride Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: dexamethasone Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: doxorubicin hydrochloride Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: leucovorin calcium Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: mercaptopurine Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: methotrexate Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: pegaspargase Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: thioguanine Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: vincristine sulfate Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Radiation: radiation therapy Patients undergo radiation therapy periodically during study treatment |
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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).
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Drug: cyclophosphamide
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: cytarabine Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: daunorubicin hydrochloride Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: dexamethasone Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: doxorubicin hydrochloride Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: leucovorin calcium Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: mercaptopurine Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: methotrexate Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: pegaspargase Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: thioguanine Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: vincristine sulfate Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Radiation: radiation therapy Patients undergo radiation therapy periodically during study treatment |
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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:
Drug: cytarabine Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: daunorubicin hydrochloride Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: dexamethasone Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: doxorubicin hydrochloride Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: leucovorin calcium Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: mercaptopurine Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: methotrexate Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: pegaspargase Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: thioguanine Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: vincristine sulfate Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Radiation: radiation therapy Patients undergo radiation therapy periodically during study treatment |
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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).
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Drug: cyclophosphamide
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: cytarabine Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: daunorubicin hydrochloride Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: dexamethasone Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: doxorubicin hydrochloride Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: leucovorin calcium Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: mercaptopurine Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: methotrexate Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: pegaspargase Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: prednisone Given IV or orally
Other Names:
Drug: thioguanine Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: vincristine sulfate Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Radiation: radiation therapy Patients undergo radiation therapy periodically during study treatment |
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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:
Drug: cytarabine Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: daunorubicin hydrochloride Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: doxorubicin hydrochloride Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: leucovorin calcium Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: mercaptopurine Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: methotrexate Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: pegaspargase Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: prednisone Given IV or orally
Other Names:
Drug: thioguanine Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: vincristine sulfate Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Radiation: radiation therapy Patients undergo radiation therapy periodically during study treatment |
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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:
Drug: cytarabine Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: daunorubicin hydrochloride Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: doxorubicin hydrochloride Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: leucovorin calcium Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: mercaptopurine Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: methotrexate Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: pegaspargase Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: prednisone Given IV or orally
Other Names:
Drug: thioguanine Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: vincristine sulfate Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
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:
Drug: cytarabine Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: daunorubicin hydrochloride Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: dexamethasone Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: doxorubicin hydrochloride Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: leucovorin calcium Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: mercaptopurine Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: methotrexate Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: pegaspargase Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: prednisone Given IV or orally
Other Names:
Drug: thioguanine Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: vincristine sulfate Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
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:
Drug: cytarabine Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: daunorubicin hydrochloride Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: dexamethasone Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: leucovorin calcium Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: mercaptopurine Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: methotrexate Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: pegaspargase Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: prednisone Given IV or orally
Other Names:
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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:
Drug: cytarabine Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: daunorubicin hydrochloride Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: dexamethasone Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: doxorubicin hydrochloride Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: leucovorin calcium Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: mercaptopurine Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: methotrexate Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: pegaspargase Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: prednisone Given IV or orally
Other Names:
Drug: thioguanine Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: vincristine sulfate Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
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:
Drug: cytarabine Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: daunorubicin hydrochloride Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: dexamethasone Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: doxorubicin hydrochloride Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: leucovorin calcium Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: mercaptopurine Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: methotrexate Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: pegaspargase Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: prednisone Given IV or orally
Other Names:
Drug: thioguanine Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: vincristine sulfate Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
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:
Drug: cytarabine Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: daunorubicin hydrochloride Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: dexamethasone Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: doxorubicin hydrochloride Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: leucovorin calcium Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: mercaptopurine Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: methotrexate Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: pegaspargase Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: thioguanine Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: vincristine sulfate Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
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:
Drug: cytarabine Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: daunorubicin hydrochloride Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: dexamethasone Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: leucovorin calcium Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: mercaptopurine Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: methotrexate Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: pegaspargase Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: prednisone Given IV or orally
Other Names:
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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.
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.
| 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
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
Show 213 Study Locations
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
| Study Chair: | Eric C. Larsen, MD | Maine Children's Cancer Program at Barbara Bush Children's Hospital |
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):
| Responsible Party: | Children's Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00075725 History of Changes |
| 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 21, 2017 |
| 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:
|
Leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Lymphoid Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Dexamethasone acetate Dexamethasone Prednisone Liposomal doxorubicin Pegaspargase Cyclophosphamide |
Doxorubicin Methotrexate Cytarabine Vincristine Daunorubicin Asparaginase 6-Mercaptopurine Thioguanine BB 1101 Levoleucovorin Leucovorin Anti-Inflammatory Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents |