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← Childhood Acute Lymphoblastic Leukemia

NCT00381680 · STUDY IN CONTEXT

Low-Dose or High-Dose Vincristine and Combination Chemotherapy in Treating Young Patients With Relapsed B-Cell 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.

primary · POSTED

Percentage of patients who were event free at 3 years among those on Standard VCR dosing who did not undergo Hematopoietic Stem Cell Transplant (SCT).

The analysis is limited to eligible patients on regimen A (Standard VCR dosing) who did not undergo SCT.

→

secondary · POSTED

Percentage of patients who developed at least 1 episode of grade 2 to 4 neuropathy.

The total number of patients for CC or CT genotype is 81 and for high-risk CEP72 genotype is 18. No related by arm data were provided.

→

secondary · POSTED

Percent of unfavorable gene expression profile of early versus late marrow relapse.

The data were not collected due to the lack of funds.

→

secondary · POSTED

Percentage of patients who had minimal residual disease (MRD) \< 0.01% among those with isolated BM or combined BM relapse \>= 36 months and had successful MRD determinations at End Block 1

This analysis is limited to all eligible patients with isolated BM or combined BM relapse \>= 36 months and had successful MRD determinations at End Block 1.

→

secondary · POSTED

Percentage of patients who had minimal residual disease (MRD) \< 0.01% among those with isolated BM or combined BM relapse \>= 36 months and had successful MRD determinations at End Block 3.

This analysis is limited to all eligible patients with isolated BM or combined BM relapse \>= 36 months and had successful MRD determinations at End Block 3.

→

secondary · POSTED

Percentage of patients who were event free at 3 years among those with isolated BM or combined BM relapse \>= 36 months.

The percentage of patients (pts) who were event free at 3 years among those with isolated BM or combined BM relapse \>= 36 months. Pts with MRD \<0.01% at the end of Block 1 (MRD \< 0.01% BL1); MRD \>= 0.01% at the end of Block 1 (MRD\>= 0.01% BL1); MRD \< 0.01% at the end of Block 3 (MRD \< 0.01% BL3);MRD \>=0.01% at the end of Block 3.

→

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
NCT00381680
trial label
Low-Dose or High-Dose Vincristine and Combination Chemotherapy in Treating Young Patients With Relapsed B-Cell 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
2
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia-pediatric
    nct id
    NCT00381680
    outcome key
    om-0000
    source section id
    NCT00381680-om-0000
    source outcome index
    0
    endpoint
    Event Free Survival. EFS
    endpoint definition
    Percentage of patients who were event free at 3 years among those on Standard VCR dosing who did not undergo Hematopoietic Stem Cell Transplant (SCT).
    time origin
    3 years after enrollment
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The analysis is limited to eligible patients on regimen A (Standard VCR dosing) who did not undergo SCT.
    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
    NCT00381680
    outcome key
    om-0001
    source section id
    NCT00381680-om-0001
    source outcome index
    1
    endpoint
    Frequency and Severity of Adverse Effects
    endpoint definition
    Percentage of patients who developed at least 1 episode of grade 2 to 4 neuropathy.
    time origin
    Up to 107 weeks
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The total number of patients for CC or CT genotype is 81 and for high-risk CEP72 genotype is 18. No related by arm data were provided.
    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
    NCT00381680
    outcome key
    om-0002
    source section id
    NCT00381680-om-0002
    source outcome index
    2
    endpoint
    Gene Expression Profile
    endpoint definition
    Percent of unfavorable gene expression profile of early versus late marrow relapse.
    time origin
    Up to 36 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The data were not collected due to the lack of funds.
    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
    NCT00381680
    outcome key
    om-0003
    source section id
    NCT00381680-om-0003
    source outcome index
    3
    endpoint
    Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 1
    endpoint definition
    Percentage of patients who had minimal residual disease (MRD) \< 0.01% among those with isolated BM or combined BM relapse \>= 36 months and had successful MRD determinations at End Block 1
    time origin
    End of Block 1 (35 days) of Induction therapy
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    This analysis is limited to all eligible patients with isolated BM or combined BM relapse \>= 36 months and had successful MRD determinations at End Block 1.
    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
    NCT00381680
    outcome key
    om-0004
    source section id
    NCT00381680-om-0004
    source outcome index
    4
    endpoint
    Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 3
    endpoint definition
    Percentage of patients who had minimal residual disease (MRD) \< 0.01% among those with isolated BM or combined BM relapse \>= 36 months and had successful MRD determinations at End Block 3.
    time origin
    End of Block 3 (105 days) of Induction therapy
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    This analysis is limited to all eligible patients with isolated BM or combined BM relapse \>= 36 months and had successful MRD determinations at End Block 3.
    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
    NCT00381680
    outcome key
    om-0005
    source section id
    NCT00381680-om-0005
    source outcome index
    5
    endpoint
    Event Free Survival (EFS)
    endpoint definition
    Percentage of patients who were event free at 3 years among those with isolated BM or combined BM relapse \>= 36 months.
    time origin
    3 years
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The percentage of patients (pts) who were event free at 3 years among those with isolated BM or combined BM relapse \>= 36 months. Pts with MRD \<0.01% at the end of Block 1 (MRD \< 0.01% BL1); MRD \>= 0.01% at the end of Block 1 (MRD\>= 0.01% BL1); MRD \< 0.01% at the end of Block 3 (MRD \< 0.01% BL3);MRD \>=0.01% at the end of Block 3.
    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
    NCT00381680
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Regimen A: Standard Vincristine Dosing
    regimen
    Standard VCR dosing (1.5 mg/m\^2, max 2 mg)
    analyzed count
    142
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00381680-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia-pediatric
    nct id
    NCT00381680
    outcome key
    om-0001
    arm key
    OG000
    arm label
    All Patients
    regimen
    This analysis looks at all eligible patients with CC or CT genotypes as well as all eligible patients with the high-risk CEP72 genotype (TT at rs924607).
    analyzed count
    99
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00381680-om-0001#groups/OG000
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia-pediatric
    nct id
    NCT00381680
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Regimen A: Standard Vincristine Dosing
    regimen
    Standard VCR dosing (1.5 mg/m\^2, max 2 mg)
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00381680-om-0002#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia-pediatric
    nct id
    NCT00381680
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Arm B: Randomized High Dose Vincristine Regimen
    regimen
    Intensive VCR dosing (2 mg/m\^2, max 2.5 mg)
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00381680-om-0002#groups/OG001
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia-pediatric
    nct id
    NCT00381680
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Regimen A
    regimen
    Standard VCR dosing (1.5 mg/m\^2, max 2 mg)
    analyzed count
    122
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00381680-om-0003#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia-pediatric
    nct id
    NCT00381680
    outcome key
    om-0003
    arm key
    OG001
    arm label
    Regimen B
    regimen
    Intensive VCR dosing (2 mg/m\^2, max 2.5 mg)
    analyzed count
    53
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00381680-om-0003#groups/OG001
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia-pediatric
    nct id
    NCT00381680
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Regimen A
    regimen
    Standard VCR dosing (1.5 mg/m\^2, max 2mg)
    analyzed count
    70
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00381680-om-0004#groups/OG000
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia-pediatric
    nct id
    NCT00381680
    outcome key
    om-0004
    arm key
    OG001
    arm label
    Regimen B
    regimen
    Intensive VCR dosing (2 mg/m\^2, max 2.5 mg)
    analyzed count
    27
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00381680-om-0004#groups/OG001
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia-pediatric
    nct id
    NCT00381680
    outcome key
    om-0005
    arm key
    OG000
    arm label
    Regimen A
    regimen
    Standard VCR dosing (1.5 mg/m\^2, max 2mg)
    analyzed count
    127
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00381680-om-0005#groups/OG000
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia-pediatric
    nct id
    NCT00381680
    outcome key
    om-0005
    arm key
    OG001
    arm label
    Regimen B
    regimen
    Intensive VCR dosing (2 mg/m\^2, max 2.5 mg)
    analyzed count
    54
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00381680-om-0005#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia-pediatric
    nct id
    NCT00381680
    harm key
    EG000
    source section id
    NCT00381680-ae
    event group key
    EG000
    event group label
    Regimen A: Standard Vincristine Dosing
    serious affected
    40
    serious at risk
    203
    other affected
    189
    other at risk
    203
    frequency threshold
    0
    collection period
    Source null
    event definition
    Only eligible patients are included in the toxicity adverse events for both serious and other.
    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
    NCT00381680
    harm key
    EG001
    source section id
    NCT00381680-ae
    event group key
    EG001
    event group label
    Arm B: Randomized High Dose Vincristine Regimen
    serious affected
    11
    serious at risk
    68
    other affected
    66
    other at risk
    68
    frequency threshold
    0
    collection period
    Source null
    event definition
    Only eligible patients are included in the toxicity adverse events for both serious and other.
    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