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← Acute Lymphoblastic Leukemia

NCT00137111 · STUDY IN CONTEXT

Therapy for Newly Diagnosed Patients With Acute Lymphoblastic Leukemia

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.

exploratory · POSTED

Prednisolone sensitivity was measured in primary leukemia cells from bone marrow collected at diagnosis. Expression of CASP1 was determined by HG-U133A microarray. Values given are gene expression values, and the unit is arbitrary units (AU) defined as scaled fluorescence measured on microarray.

One hundred forty-four (144) patients were evaluable to assess prednisolone sensitivity measured in bone marrow ALL cells and CASP1 expression in RNA by MTT assay.

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primary · POSTED

EFS was measured from the start of on-study to the date of first treatment failure of any kind (relapse, death, lineage switch, or second malignancy) or to the last date of follow-up. Failure to enter remission was considered an event at time zero. Measurement was determined by Kaplan-Meyer estimate.

498 enrolled patients were eligible for analysis to estimate the overall event-free survival of children at least one year of age at diagnosis who are treated with risk-directed therapy.

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primary · POSTED

CCR was measured from end of week 56 therapy to the date of first treatment failure of any kind (relapse, death, lineage switch, or second malignancy) or to the last date of follow-up. Measurement was determined by Kaplan-Meyer estimate.

Patients meeting the following high risk CNS Relapse criteria: white cell blood cell count at diagnosis more than 100,000; Philadelphia Chromosome Positive; CNS 3 at diagnosis; T-Lineage with white blood cell count more than 50,000.

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secondary · POSTED

Detection of MRD at end of induction where positive MRD was defined as one or more leukemic cell per 10,000 mononuclear bone-marrow cells (\>=0.01%).

Patients who completed induction and had successful MRD studies on day 46.

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secondary · POSTED

Children were randomly assigned to receive initial single-agent treatment with HDMTX (1g/m\^2) as either a 24-hour infusion or a 4-hour infusion and the outcome measure was the accumulation of MTXPG in leukemia cells.

The 286 patients randomized to treatment with high-dose methotrexate (HDMTX) who had methotrexate polyglutamate (MTXPG) concentration measured in bone marrow ALL cells .

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secondary · POSTED

White blood cell (leukocytes) counts in peripheral blood by Complete Blood Count Measurement: Percentage change of leukemia cells from baseline

Three hundred twenty (320) patients were evaluable to assess the influence of infusion duration on methotrexate's antileukemic effects.

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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
nct id
NCT00137111
trial label
Therapy for Newly Diagnosed Patients With Acute Lymphoblastic Leukemia
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
1
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia
    nct id
    NCT00137111
    outcome key
    om-0005
    source section id
    NCT00137111-om-0005
    source outcome index
    5
    endpoint
    Median Difference in CASP1 Gene Expression in Primary Leukemia Cells of Patients in Glucocorticoid-resistant Cells vs Glucocorticoid-sensitive Cells
    endpoint definition
    Prednisolone sensitivity was measured in primary leukemia cells from bone marrow collected at diagnosis. Expression of CASP1 was determined by HG-U133A microarray. Values given are gene expression values, and the unit is arbitrary units (AU) defined as scaled fluorescence measured on microarray.
    time origin
    Pre-treatment
    analysis role
    exploratory
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    One hundred forty-four (144) patients were evaluable to assess prednisolone sensitivity measured in bone marrow ALL cells and CASP1 expression in RNA by MTT assay.
    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
    nct id
    NCT00137111
    outcome key
    om-0000
    source section id
    NCT00137111-om-0000
    source outcome index
    0
    endpoint
    Overall Event-free Survival (EFS)
    endpoint definition
    EFS was measured from the start of on-study to the date of first treatment failure of any kind (relapse, death, lineage switch, or second malignancy) or to the last date of follow-up. Failure to enter remission was considered an event at time zero. Measurement was determined by Kaplan-Meyer estimate.
    time origin
    Median follow-up time (range) 5.6 (1.3 to 8.9) years
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    498 enrolled patients were eligible for analysis to estimate the overall event-free survival of children at least one year of age at diagnosis who are treated with risk-directed therapy.
    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
    nct id
    NCT00137111
    outcome key
    om-0001
    source section id
    NCT00137111-om-0001
    source outcome index
    1
    endpoint
    Continuous Complete Remission Since Week 56 Therapy.
    endpoint definition
    CCR was measured from end of week 56 therapy to the date of first treatment failure of any kind (relapse, death, lineage switch, or second malignancy) or to the last date of follow-up. Measurement was determined by Kaplan-Meyer estimate.
    time origin
    Median follow up time (range) 4.5 (1 to 7.8) years
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Patients meeting the following high risk CNS Relapse criteria: white cell blood cell count at diagnosis more than 100,000; Philadelphia Chromosome Positive; CNS 3 at diagnosis; T-Lineage with white blood cell count more than 50,000.
    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
    nct id
    NCT00137111
    outcome key
    om-0002
    source section id
    NCT00137111-om-0002
    source outcome index
    2
    endpoint
    Minimal Residual Disease (MRD)
    endpoint definition
    Detection of MRD at end of induction where positive MRD was defined as one or more leukemic cell per 10,000 mononuclear bone-marrow cells (\>=0.01%).
    time origin
    End of Induction (Day 46 MRD measurement)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Patients who completed induction and had successful MRD studies on day 46.
    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
    nct id
    NCT00137111
    outcome key
    om-0003
    source section id
    NCT00137111-om-0003
    source outcome index
    3
    endpoint
    Mean Difference of Active Methotrexate Polyglutamates (MTXPG) in Leukemia Cells Between Two Arms (4 Hours vs. 24 Hours).
    endpoint definition
    Children were randomly assigned to receive initial single-agent treatment with HDMTX (1g/m\^2) as either a 24-hour infusion or a 4-hour infusion and the outcome measure was the accumulation of MTXPG in leukemia cells.
    time origin
    42 hours after start of high dose methotrexate infusion (HDMTX)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The 286 patients randomized to treatment with high-dose methotrexate (HDMTX) who had methotrexate polyglutamate (MTXPG) concentration measured in bone marrow ALL cells .
    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
    nct id
    NCT00137111
    outcome key
    om-0004
    source section id
    NCT00137111-om-0004
    source outcome index
    4
    endpoint
    Circulating Leukemia Cells in Peripheral Blood Change From Prior to the Methotrexate Infusion to Three Days After Between Two Arms (4 Hours vs. 24 Hours)
    endpoint definition
    White blood cell (leukocytes) counts in peripheral blood by Complete Blood Count Measurement: Percentage change of leukemia cells from baseline
    time origin
    Immediately before the methotrexate infusion and three days after subsequent infusion
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Three hundred twenty (320) patients were evaluable to assess the influence of infusion duration on methotrexate's antileukemic effects.
    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
    nct id
    NCT00137111
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Total Therapy
    regimen
    Total therapy applies to all eligible patients.
    analyzed count
    498
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00137111-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia
    nct id
    NCT00137111
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Patients With High Risk of CNS Relapse
    regimen
    This is a subset of all patients enrolled. It is not a specific treatment arm.
    analyzed count
    70
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00137111-om-0001#groups/OG000
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia
    nct id
    NCT00137111
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Total Therapy
    regimen
    Total therapy applies to all eligible patients.
    analyzed count
    492
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00137111-om-0002#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia
    nct id
    NCT00137111
    outcome key
    om-0003
    arm key
    OG000
    arm label
    4 hr
    regimen
    4 hour High-Dose Methotrexate Infusion in upfront window treatment
    analyzed count
    136
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00137111-om-0003#groups/OG000
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia
    nct id
    NCT00137111
    outcome key
    om-0003
    arm key
    OG001
    arm label
    24 hr
    regimen
    24 hour High-Dose Methotrexate Infusion in upfront window treatment
    analyzed count
    150
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00137111-om-0003#groups/OG001
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia
    nct id
    NCT00137111
    outcome key
    om-0004
    arm key
    OG000
    arm label
    4 hr
    regimen
    4 hour High-Dose Methotrexate Infusion in upfront window treatment
    analyzed count
    156
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00137111-om-0004#groups/OG000
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia
    nct id
    NCT00137111
    outcome key
    om-0004
    arm key
    OG001
    arm label
    24 hr
    regimen
    24 hour High-Dose Methotrexate Infusion in upfront window treatment
    analyzed count
    164
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00137111-om-0004#groups/OG001
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia
    nct id
    NCT00137111
    outcome key
    om-0005
    arm key
    OG000
    arm label
    Total Therapy
    regimen
    Total therapy applies to all eligible patients.
    analyzed count
    144
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00137111-om-0005#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia
    nct id
    NCT00137111
    harm key
    EG000
    source section id
    NCT00137111-ae
    event group key
    EG000
    event group label
    Total Therapy
    serious affected
    74
    serious at risk
    498
    other affected
    468
    other at risk
    498
    frequency threshold
    5
    collection period
    Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed.
    event definition
    Source null
    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