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← Childhood Acute Lymphoblastic Leukemia

NCT00075725 · STUDY IN CONTEXT

Dexamethasone Compared With Prednisone During Induction Therapy and Methotrexate With or Without Leucovorin During Maintenance Therapy in Treating Patients With Newly Diagnosed Hig

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

Event Free Probability.

Group "Prednisone and High Dose MTX (non-random)" who either had EFS events occur before 5 years or did not have minimum 5 years of follow-up.

→

secondary · POSTED

Bone marrow MRD status is defined as positive with \>= 0.1 detectable leukemia cells, and negative with \< 0.1 detectable leukemia cells.

Groups "Prednisone Capizzi MTX (Down's Syndrome)", "Dexamethasone, Capizzi MTX (non-random)" \& "Prednisone and High Dose MTX (non-random) are not included in this OM as no patients survived the 5 year window for analysis. Cohort of MRD Positive patients who either had EFS/OS events occur before 5 years or did not have minimum 5 years of follow-up.

→

secondary · POSTED

Bone marrow MRD status is defined as negative with \< .01 detectable leukemia cells.

Patients on Arm/Group "Prednisone and High Dose Methotrexate (non randomly assigned)" are not included in the OM as there were no survivors for the 5 year duration. Cohort of MRD Negative patients some of whom have had EFS/OS events after 5 years or have minimum 5 years of follow-up.

→

secondary · POSTED

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.

Source null

→

secondary · POSTED

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.

Source null

→

secondary · POSTED

Bone marrow MRD status is defined as positive with \>= 0.1 detectable leukemia cells.

Groups "Prednisone Capizzi MTX (Down's Syndrome)", "Dexamethasone, Capizzi MTX (non-random)" \& "Prednisone and High Dose MTX (non-random) are not included in this OM as no patients survived the 5 year window for analysis. Cohort of MRD Positive patients who either had EFS/OS events occur before 5 years or did not have minimum 5 years of follow-up.

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-acute-lymphoblastic-leukemia-pediatric
nct id
NCT00075725
trial label
Dexamethasone Compared With Prednisone During Induction Therapy and Methotrexate With or Without Leucovorin During Maintenance Therapy in Treating Patients With Newly Diagnosed Hig
applicability
narrower
applicability note
Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
provenance class
regulator-cited
discovery note
Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
outcome Count
6
harms Count
12
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia-pediatric
    nct id
    NCT00075725
    outcome key
    om-0000
    source section id
    NCT00075725-om-0000
    source outcome index
    0
    endpoint
    Comparison of the Increase in Cure Rate of High Risk ALL Without Causing More Serious Side Effects Between Interventions
    endpoint definition
    Event Free Probability.
    time origin
    5 years
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Group "Prednisone and High Dose MTX (non-random)" who either had EFS events occur before 5 years or did not have minimum 5 years of follow-up.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia-pediatric
    nct id
    NCT00075725
    outcome key
    om-0001
    source section id
    NCT00075725-om-0001
    source outcome index
    1
    endpoint
    Correlation of Minimal Residual Disease (MRD) Positive With Overall Survival (OS)
    endpoint definition
    Bone marrow MRD status is defined as positive with \>= 0.1 detectable leukemia cells, and negative with \< 0.1 detectable leukemia cells.
    time origin
    5 Years
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Groups "Prednisone Capizzi MTX (Down's Syndrome)", "Dexamethasone, Capizzi MTX (non-random)" \& "Prednisone and High Dose MTX (non-random) are not included in this OM as no patients survived the 5 year window for analysis. Cohort of MRD Positive patients who either had EFS/OS events occur before 5 years or did not have minimum 5 years of follow-up.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia-pediatric
    nct id
    NCT00075725
    outcome key
    om-0002
    source section id
    NCT00075725-om-0002
    source outcome index
    2
    endpoint
    Correlation of Minimal Residual Disease (MRD) Negative With Overall Survival (OS).
    endpoint definition
    Bone marrow MRD status is defined as negative with \< .01 detectable leukemia cells.
    time origin
    5 years
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Patients on Arm/Group "Prednisone and High Dose Methotrexate (non randomly assigned)" are not included in the OM as there were no survivors for the 5 year duration. Cohort of MRD Negative patients some of whom have had EFS/OS events after 5 years or have minimum 5 years of follow-up.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia-pediatric
    nct id
    NCT00075725
    outcome key
    om-0003
    source section id
    NCT00075725-om-0003
    source outcome index
    3
    endpoint
    Correlation of Early Marrow Response Status With MRD Positive.
    endpoint definition
    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.
    time origin
    Day 29
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia-pediatric
    nct id
    NCT00075725
    outcome key
    om-0004
    source section id
    NCT00075725-om-0004
    source outcome index
    4
    endpoint
    Correlation of Early Marrow Response Status With MRD Negative.
    endpoint definition
    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.
    time origin
    Day 29
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia-pediatric
    nct id
    NCT00075725
    outcome key
    om-0005
    source section id
    NCT00075725-om-0005
    source outcome index
    5
    endpoint
    Correlation of Minimal Residual Disease (MRD) Positive With Event Free Survival (EFS)
    endpoint definition
    Bone marrow MRD status is defined as positive with \>= 0.1 detectable leukemia cells.
    time origin
    5 years
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Groups "Prednisone Capizzi MTX (Down's Syndrome)", "Dexamethasone, Capizzi MTX (non-random)" \& "Prednisone and High Dose MTX (non-random) are not included in this OM as no patients survived the 5 year window for analysis. Cohort of MRD Positive patients who either had EFS/OS events occur before 5 years or did not have minimum 5 years of follow-up.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia-pediatric
    nct id
    NCT00075725
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Dexamethasone and Capizzi Methotrexate Patients < 10 Years
    regimen
    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).
    analyzed count
    218
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00075725-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia-pediatric
    nct id
    NCT00075725
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Dexamethasone, High Dose Methotrexate (Non Randomly Assigned)
    regimen
    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).
    analyzed count
    90
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00075725-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia-pediatric
    nct id
    NCT00075725
    outcome key
    om-0000
    arm key
    OG002
    arm label
    Dexamethasone & Capizzi Methotrexate Patients => 10 Years Old
    regimen
    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).
    analyzed count
    261
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00075725-om-0000#groups/OG002
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia-pediatric
    nct id
    NCT00075725
    outcome key
    om-0000
    arm key
    OG003
    arm label
    Dexamethasone, High Dose Methotrexate (IM) < 10 Years
    regimen
    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).
    analyzed count
    206
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00075725-om-0000#groups/OG003
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia-pediatric
    nct id
    NCT00075725
    outcome key
    om-0000
    arm key
    OG004
    arm label
    Prednisone, Capizzi Methotrexate <10 Years
    regimen
    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.
    analyzed count
    214
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00075725-om-0000#groups/OG004
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia-pediatric
    nct id
    NCT00075725
    outcome key
    om-0000
    arm key
    OG005
    arm label
    Prednisone, Capezzi Methotrexate >= 10 Years
    regimen
    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.
    analyzed count
    598
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00075725-om-0000#groups/OG005
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia-pediatric
    nct id
    NCT00075725
    outcome key
    om-0000
    arm key
    OG006
    arm label
    Predisone and High Dose Methotrexate < 10 Yrs Old
    regimen
    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.
    analyzed count
    213
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00075725-om-0000#groups/OG006
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia-pediatric
    nct id
    NCT00075725
    outcome key
    om-0000
    arm key
    OG007
    arm label
    Prenisone and High Dose Methotrexate >=10 Years
    regimen
    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.
    analyzed count
    601
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00075725-om-0000#groups/OG007
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia-pediatric
    nct id
    NCT00075725
    outcome key
    om-0000
    arm key
    OG008
    arm label
    Dexamethasone, High Dose Methotrexate (IM) >= 10 Years
    regimen
    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).
    analyzed count
    262
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00075725-om-0000#groups/OG008
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia-pediatric
    nct id
    NCT00075725
    outcome key
    om-0000
    arm key
    OG009
    arm label
    Prenisone, Capezzi Methotrexate (Down's Syndrome)
    regimen
    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.
    analyzed count
    30
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00075725-om-0000#groups/OG009
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia-pediatric
    nct id
    NCT00075725
    outcome key
    om-0000
    arm key
    OG010
    arm label
    Dexamethasone, Capizzi Methotrexate Down Syndrome (Non Random)
    regimen
    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).
    analyzed count
    9
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00075725-om-0000#groups/OG010
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia-pediatric
    nct id
    NCT00075725
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Dexamethasone and Capizzi Methotrexate Patients < 10 Years
    regimen
    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).
    analyzed count
    28
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00075725-om-0001#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia-pediatric
    nct id
    NCT00075725
    harm key
    EG000
    source section id
    NCT00075725-ae
    event group key
    EG000
    event group label
    Dexamethasone and Capizzi Methotrexate Patients < 10 Years
    serious affected
    16
    serious at risk
    218
    other affected
    215
    other at risk
    218
    frequency threshold
    0
    collection period
    Source null
    event definition
    SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia-pediatric
    nct id
    NCT00075725
    harm key
    EG001
    source section id
    NCT00075725-ae
    event group key
    EG001
    event group label
    Dexamethasone, High Dose Methotrexate (Non Randomly Assigned)
    serious affected
    17
    serious at risk
    90
    other affected
    87
    other at risk
    90
    frequency threshold
    0
    collection period
    Source null
    event definition
    SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia-pediatric
    nct id
    NCT00075725
    harm key
    EG002
    source section id
    NCT00075725-ae
    event group key
    EG002
    event group label
    Dexamethasone & Capizzi Methotrexate Patients => 10 Years Old
    serious affected
    42
    serious at risk
    261
    other affected
    250
    other at risk
    261
    frequency threshold
    0
    collection period
    Source null
    event definition
    SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia-pediatric
    nct id
    NCT00075725
    harm key
    EG003
    source section id
    NCT00075725-ae
    event group key
    EG003
    event group label
    Dexamethasone, High Dose Methotrexate (IM) < 10 Years
    serious affected
    25
    serious at risk
    206
    other affected
    203
    other at risk
    206
    frequency threshold
    0
    collection period
    Source null
    event definition
    SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia-pediatric
    nct id
    NCT00075725
    harm key
    EG004
    source section id
    NCT00075725-ae
    event group key
    EG004
    event group label
    Prednisone, Capizzi Methotrexate <10 Years
    serious affected
    20
    serious at risk
    214
    other affected
    212
    other at risk
    214
    frequency threshold
    0
    collection period
    Source null
    event definition
    SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia-pediatric
    nct id
    NCT00075725
    harm key
    EG005
    source section id
    NCT00075725-ae
    event group key
    EG005
    event group label
    Prednisone, Capezzi Methotrexate >= 10 Years
    serious affected
    64
    serious at risk
    598
    other affected
    564
    other at risk
    598
    frequency threshold
    0
    collection period
    Source null
    event definition
    SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia-pediatric
    nct id
    NCT00075725
    harm key
    EG006
    source section id
    NCT00075725-ae
    event group key
    EG006
    event group label
    Prednisone and High Dose Methotrexate < 10 Yrs Old
    serious affected
    16
    serious at risk
    213
    other affected
    204
    other at risk
    213
    frequency threshold
    0
    collection period
    Source null
    event definition
    SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia-pediatric
    nct id
    NCT00075725
    harm key
    EG007
    source section id
    NCT00075725-ae
    event group key
    EG007
    event group label
    Prednisone and High Dose Methotrexate >=10 Years
    serious affected
    67
    serious at risk
    601
    other affected
    576
    other at risk
    601
    frequency threshold
    0
    collection period
    Source null
    event definition
    SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia-pediatric
    nct id
    NCT00075725
    harm key
    EG008
    source section id
    NCT00075725-ae
    event group key
    EG008
    event group label
    Dexamethasone, High Dose Methotrexate (IM) >= 10 Years
    serious affected
    27
    serious at risk
    262
    other affected
    256
    other at risk
    262
    frequency threshold
    0
    collection period
    Source null
    event definition
    SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia-pediatric
    nct id
    NCT00075725
    harm key
    EG009
    source section id
    NCT00075725-ae
    event group key
    EG009
    event group label
    Prednisone, Capezzi Methotrexate (Down's Syndrome)
    serious affected
    3
    serious at risk
    30
    other affected
    30
    other at risk
    30
    frequency threshold
    0
    collection period
    Source null
    event definition
    SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia-pediatric
    nct id
    NCT00075725
    harm key
    EG010
    source section id
    NCT00075725-ae
    event group key
    EG010
    event group label
    Dexamethasone, Capizzi Methotrexate Down Syndrome (Non Random)
    serious affected
    3
    serious at risk
    9
    other affected
    9
    other at risk
    9
    frequency threshold
    0
    collection period
    Source null
    event definition
    SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia-pediatric
    nct id
    NCT00075725
    harm key
    EG011
    source section id
    NCT00075725-ae
    event group key
    EG011
    event group label
    Prednisone and High Dose Methotrexate (Non Randomly Assigned)
    serious affected
    1
    serious at risk
    23
    other affected
    20
    other at risk
    23
    frequency threshold
    0
    collection period
    Source null
    event definition
    SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
quality of life
    setting source links

      Preserved source evidence · Not medical advice