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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

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT00075725
First received: January 9, 2004
Last updated: February 14, 2017
Last verified: February 2017
Results First Received: July 10, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: No masking;   Primary Purpose: Treatment
Condition: Leukemia
Interventions: 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

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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Dexamethasone and Capizzi Methotrexate Patients < 10 Years Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
Dexamethasone, High Dose Methotrexate (Non Randomly Assigned) Patients non-randomly assigned to the DH (High Dose) regimen based on one (or more) of the following characteristics: (1) CNS3 status at entry, (2) testicular leukemic involvement at entry, or (3) extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
Dexamethasone & Capizzi Methotrexate Patients => 10 Years Old Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
Dexamethasone, High Dose Methotrexate (IM) < 10 Years Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
Prednisone, Capizzi Methotrexate <10 Years Patients in regimen PC (Prednisone, Capizzi) will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
Prednisone, Capezzi Methotrexate >= 10 Years Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
Prednisone and High Dose Methotrexate < 10 Yrs Old Patients randomly assigned to the PH (Prednisone, High Dose MTX) regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
Prednisone and High Dose Methotrexate >=10 Years Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
Dexamethasone, High Dose Methotrexate (IM) >= 10 Years Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
Prednisone, Capezzi Methotrexate (Down's Syndrome) Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
Dexamethasone, Capizzi Methotrexate Down Syndrome (Non Random) Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
Prednisone and High Dose Methotrexate (Non Randomly Assigned) 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 intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal 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.

Participant Flow:   Overall Study
    Dexamethasone and Capizzi Methotrexate Patients < 10 Years   Dexamethasone, High Dose Methotrexate (Non Randomly Assigned)   Dexamethasone & Capizzi Methotrexate Patients => 10 Years Old   Dexamethasone, High Dose Methotrexate (IM) < 10 Years   Prednisone, Capizzi Methotrexate <10 Years   Prednisone, Capezzi Methotrexate >= 10 Years   Prednisone and High Dose Methotrexate < 10 Yrs Old   Prednisone and High Dose Methotrexate >=10 Years   Dexamethasone, High Dose Methotrexate (IM) >= 10 Years   Prednisone, Capezzi Methotrexate (Down's Syndrome)   Dexamethasone, Capizzi Methotrexate Down Syndrome (Non Random)   Prednisone and High Dose Methotrexate (Non Randomly Assigned)
STARTED   246   106   296   246   232   710   246   696   302   34   12   28 
COMPLETED   172   57   175   168   166   397   171   401   185   16   3   10 
NOT COMPLETED   74   49   121   78   66   313   75   295   117   18   9   18 
Adverse Event                6                6                20                8                4                38                3                51                15                4                2                2 
Death                3                5                10                2                3                25                4                22                14                4                3                0 
Lost to Follow-up                1                1                4                1                0                13                2                4                1                0                0                0 
Physician Decision                2                6                5                8                4                19                3                17                5                0                1                0 
Pregnancy                0                0                0                0                0                1                0                1                0                0                0                0 
Protocol Violation                1                1                0                3                3                2                1                2                3                0                0                1 
Withdrawal by Subject                12                3                6                10                6                27                7                31                10                2                0                0 
Disease Progression, all other reasons                17                5                33                6                21                59                20                46                21                4                0                5 
Patient off treatment                0                0                1                2                1                0                0                2                1                0                0                0 
Ineligible or wrong diagnosis                8                3                3                10                3                17                6                9                10                1                2                4 
Pt/Guardian refused RT therapy                1                0                1                2                1                0                0                0                0                0                0                0 
Pt non compliant with therapy                2                1                1                0                2                14                2                5                3                0                0                0 
Pt age out of range for treatment                0                1                0                0                0                1                0                1                0                0                0                0 
Insurance issues                0                1                0                1                1                1                0                1                0                0                0                0 
MRD positive after extended ind                0                1                1                0                1                2                0                1                0                0                0                0 
Pt has very high risk ALL characteristic                15                11                26                18                11                75                23                74                29                1                0                3 
Inevaluable                1                1                4                2                2                9                1                11                2                0                1                0 
Other                4                2                1                1                1                4                2                9                2                1                0                3 
Pt trying to find a BM donor                0                1                0                0                0                0                0                0                0                0                0                0 
Clinic chart lost unable to recreate                0                0                1                0                0                0                0                0                0                0                0                0 
Unsuccessful institutional transfer                0                0                2                0                0                0                0                0                0                1                0                0 
specimen(s) not submitted                0                0                2                0                0                0                0                0                0                0                0                0 
Pt went to transplant                0                0                0                1                0                1                0                0                0                0                0                0 
Pt received additional steroids                0                0                0                1                0                0                0                0                0                0                0                0 
Pt relocated                0                0                0                2                0                1                1                2                1                0                0                0 
Institution Terminated                0                0                0                0                1                0                0                3                0                0                0                0 
Study Closure                1                0                0                0                1                3                0                1                0                0                0                0 
Other complications                0                0                0                0                0                1                0                0                0                0                0                0 
Pt care terminated due to pt behavior                0                0                0                0                0                0                0                1                0                0                0                0 
Pt incarcerated                0                0                0                0                0                0                0                1                0                0                0                0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Dexamethasone and Capizzi Methotrexate Patients < 10 Years Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
Dexamethasone, High Dose Methotrexate (Non Randomly Assigned) Patients non-randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) CNS3 status at entry, (2) testicular leukemic involvement at entry, or (3) extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
Dexamethasone & Capizzi Methotrexate Patients => 10 Years Old Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
Dexamethasone, High Dose Methotrexate (IM) < 10 Years Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
Prednisone, Capizzi Methotrexate <10 Years Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
Prednisone, Capezzi Methotrexate >= 10 Years Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
Prednisone and High Dose Methotrexate < 10 Yrs Old Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
Prednisone and High Dose Methotrexate >=10 Years Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
Dexamethasone, High Dose Methotrexate (IM) >= 10 Years Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
Prednisone, Capezzi Methotrexate (Down's Syndrome) Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
Dexamethasone, Capizzi Methotrexate Down Syndrome Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
Prednisone and High Dose Methotrexate (Non Randomly Assigned) Patients non-randomly assigned to the PH regimen based on one (or more) of the following characteristics: (1) CNS3 status at entry, (2) testicular leukemic involvement at entry, or (3) extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth
Total Total of all reporting groups

Baseline Measures
   Dexamethasone and Capizzi Methotrexate Patients < 10 Years   Dexamethasone, High Dose Methotrexate (Non Randomly Assigned)   Dexamethasone & Capizzi Methotrexate Patients => 10 Years Old   Dexamethasone, High Dose Methotrexate (IM) < 10 Years   Prednisone, Capizzi Methotrexate <10 Years   Prednisone, Capezzi Methotrexate >= 10 Years   Prednisone and High Dose Methotrexate < 10 Yrs Old   Prednisone and High Dose Methotrexate >=10 Years   Dexamethasone, High Dose Methotrexate (IM) >= 10 Years   Prednisone, Capezzi Methotrexate (Down's Syndrome)   Dexamethasone, Capizzi Methotrexate Down Syndrome   Prednisone and High Dose Methotrexate (Non Randomly Assigned)   Total 
Overall Participants Analyzed 
[Units: Participants]
 246   106   296   246   232   710   246   696   302   34   12   28   3154 
Age 
[Units: Participants]
Count of Participants
                         
<=18 years      246 100.0%      96  90.6%      275  92.9%      246 100.0%      232 100.0%      641  90.3%      246 100.0%      610  87.6%      266  88.1%      30  88.2%      10  83.3%      26  92.9%      2924  92.7% 
Between 18 and 65 years      0   0.0%      10   9.4%      21   7.1%      0   0.0%      0   0.0%      69   9.7%      0   0.0%      86  12.4%      36  11.9%      4  11.8%      2  16.7%      2   7.1%      230   7.3% 
>=65 years      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 4.0  (2.3)   9.3  (6.0)   14.1  (2.8)   4.1  (2.2)   4.2  (2.2)   14.7  (3.3)   4.2  (2.2)   14.5  (3.2)   14.6  (2.9)   10.5  (5.7)   12.3  (6.6)   14.4  (2.9)   10.8  (5.7) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
                         
Female      129  52.4%      31  29.2%      135  45.6%      117  47.6%      106  45.7%      321  45.2%      108  43.9%      288  41.4%      128  42.4%      18  52.9%      7  58.3%      11  39.3%      1399  44.4% 
Male      117  47.6%      75  70.8%      161  54.4%      129  52.4%      126  54.3%      389  54.8%      138  56.1%      408  58.6%      174  57.6%      16  47.1%      5  41.7%      17  60.7%      1755  55.6% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
                         
Hispanic or Latino      54  22.0%      22  20.8%      62  20.9%      55  22.4%      62  26.7%      167  23.5%      61  24.8%      168  24.1%      69  22.8%      6  17.6%      0   0.0%      7  25.0%      733  23.2% 
Not Hispanic or Latino      179  72.8%      81  76.4%      217  73.3%      182  74.0%      165  71.1%      516  72.7%      179  72.8%      504  72.4%      219  72.5%      27  79.4%      10  83.3%      20  71.4%      2299  72.9% 
Unknown or Not Reported      13   5.3%      3   2.8%      17   5.7%      9   3.7%      5   2.2%      27   3.8%      6   2.4%      24   3.4%      14   4.6%      1   2.9%      2  16.7%      1   3.6%      122   3.9% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
                         
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0%      1   0.4%      0   0.0%      4   0.6%      1   0.4%      7   1.0%      2   0.7%      1   2.9%      2  16.7%      0   0.0%      18   0.6% 
Asian      8   3.3%      6   5.7%      11   3.7%      9   3.7%      7   3.0%      21   3.0%      8   3.3%      27   3.9%      18   6.0%      2   5.9%      0   0.0%      0   0.0%      117   3.7% 
Native Hawaiian or Other Pacific Islander      2   0.8%      1   0.9%      1   0.3%      2   0.8%      1   0.4%      5   0.7%      5   2.0%      6   0.9%      2   0.7%      0   0.0%      0   0.0%      0   0.0%      25   0.8% 
Black or African American      12   4.9%      14  13.2%      24   8.1%      12   4.9%      15   6.5%      55   7.7%      14   5.7%      51   7.3%      19   6.3%      2   5.9%      0   0.0%      1   3.6%      219   6.9% 
White      196  79.7%      76  71.7%      235  79.4%      187  76.0%      175  75.4%      534  75.2%      187  76.0%      519  74.6%      227  75.2%      26  76.5%      9  75.0%      24  85.7%      2395  75.9% 
More than one race      3   1.2%      3   2.8%      1   0.3%      8   3.3%      5   2.2%      8   1.1%      5   2.0%      4   0.6%      3   1.0%      0   0.0%      0   0.0%      0   0.0%      40   1.3% 
Unknown or Not Reported      25  10.2%      6   5.7%      24   8.1%      27  11.0%      29  12.5%      83  11.7%      26  10.6%      82  11.8%      31  10.3%      3   8.8%      1   8.3%      3  10.7%      340  10.8% 


  Outcome Measures
  Show All Outcome Measures

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

2.  Secondary:   Correlation of Minimal Residual Disease (MRD) Positive With Overall Survival (OS)   [ Time Frame: 5 Years ]

3.  Secondary:   Correlation of Minimal Residual Disease (MRD) Negative With Overall Survival (OS).   [ Time Frame: 5 years ]

4.  Secondary:   Correlation of Early Marrow Response Status With MRD Positive.   [ Time Frame: Day 29 ]

5.  Secondary:   Correlation of Early Marrow Response Status With MRD Negative.   [ Time Frame: Day 29 ]

6.  Secondary:   Correlation of Minimal Residual Disease (MRD) Positive With Event Free Survival (EFS)   [ Time Frame: 5 years ]

7.  Secondary:   Correlation of Minimal Residual Disease (MRD) Negative With Event Free Survival (EFS).   [ Time Frame: 5 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The COG SDC reviewed the NLM notification related to ct.gov AE/SAE reporting. The information in ‘Additional Description’ is accurate with respect to data supplied to ct.gov.COG plans to submit data AE/SAE data consistent with the text in this field.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Results Reporting Coordinator
Organization: Children's Oncology Group
phone: 626-447-0064
e-mail: resultsreportingcoordinator@childrensoncologygroup.org


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) )
Study First Received: January 9, 2004
Results First Received: July 10, 2015
Last Updated: February 14, 2017