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← Childhood Acute Lymphoblastic Leukemia

NCT00382109 · STUDY IN CONTEXT

Tacrolimus and Methotrexate With or Without Sirolimus in Preventing Graft-Versus-Host Disease in Young Patients Undergoing Donor Stem Cell Transplant for Acute Lymphoblastic Leukem

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

An event is defined as relapse or transplant-related mortality. Relapse is defined in section 3.3 study protocol.

Two ineligible patients on experimental arm excluded from analysis.

→

secondary · POSTED

An event is defined as relapse.

2 ineligible patients on experimental arm excluded from analysis.Testing for recurrent malignancy in the blood, marrow or other sites will be used to assess relapse after transplantation. For the purpose of this study, relapse is defined by either morphological or cytogenetic evidence of ALL consistent with pre-transplant features.

→

secondary · POSTED

Death in a patient who had not relapsed after transplant is defined as transplant-related mortality event.

2 ineligible patients on experimental arm excluded from analysis.

→

secondary · POSTED

Any grade acute graft vs host disease (defined in APPENDIX II study protocol).

2 ineligible patients on experimental arm excluded from analysis. Definition of Acute GVHD: APPENDIX II: COG STEM CELL COMMITTEE CONSENSUS GUIDELINES FOR ESTABLISHING ORGAN STAGE AND OVERALL GRADE OF ACUTE GRAFT VERSUS HOST DISEASE (GVHD) page 90-96 protocol.

→

secondary · POSTED

Chronic graft vs host disease is defined in APPENDIX III of study protocol.

2 ineligible patients on experimental arm excluded from analysis. Definition of Chronic GVHD: APPENDIX III: DEFINING CHRONIC GRAFT VS. HOST DISEASE (FROM BMT CTN MOP SEPT. 2005) on page 97 protocol.

→

secondary · POSTED

An event is defined as relapse or transplant-related mortality.

We made a large number of xenograft models but were not able to correlate resistance to rapamycin in mice with outcome on the trial with the numbers that we had. For this reason, no specific publications addressing this aim were put forward.

→

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
NCT00382109
trial label
Tacrolimus and Methotrexate With or Without Sirolimus in Preventing Graft-Versus-Host Disease in Young Patients Undergoing Donor Stem Cell Transplant for Acute Lymphoblastic Leukem
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
    NCT00382109
    outcome key
    om-0000
    source section id
    NCT00382109-om-0000
    source outcome index
    0
    endpoint
    Estimated Percentage of Participants With Event Free Survival
    endpoint definition
    An event is defined as relapse or transplant-related mortality. Relapse is defined in section 3.3 study protocol.
    time origin
    at 2 years
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Two ineligible patients on experimental arm excluded from analysis.
    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
    NCT00382109
    outcome key
    om-0001
    source section id
    NCT00382109-om-0001
    source outcome index
    1
    endpoint
    Rate of Relapses
    endpoint definition
    An event is defined as relapse.
    time origin
    At 2 years
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    2 ineligible patients on experimental arm excluded from analysis.Testing for recurrent malignancy in the blood, marrow or other sites will be used to assess relapse after transplantation. For the purpose of this study, relapse is defined by either morphological or cytogenetic evidence of ALL consistent with pre-transplant features.
    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
    NCT00382109
    outcome key
    om-0002
    source section id
    NCT00382109-om-0002
    source outcome index
    2
    endpoint
    Estimated Transplant Related Mortality Percentage
    endpoint definition
    Death in a patient who had not relapsed after transplant is defined as transplant-related mortality event.
    time origin
    100 days
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    2 ineligible patients on experimental arm excluded from analysis.
    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
    NCT00382109
    outcome key
    om-0003
    source section id
    NCT00382109-om-0003
    source outcome index
    3
    endpoint
    Estimated Rate of Acute Graft VS Host Disease (GVHD)
    endpoint definition
    Any grade acute graft vs host disease (defined in APPENDIX II study protocol).
    time origin
    At 200 days
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    2 ineligible patients on experimental arm excluded from analysis. Definition of Acute GVHD: APPENDIX II: COG STEM CELL COMMITTEE CONSENSUS GUIDELINES FOR ESTABLISHING ORGAN STAGE AND OVERALL GRADE OF ACUTE GRAFT VERSUS HOST DISEASE (GVHD) page 90-96 protocol.
    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
    NCT00382109
    outcome key
    om-0004
    source section id
    NCT00382109-om-0004
    source outcome index
    4
    endpoint
    Estimated Rate of Overall Chronic Graft VS Host Disease
    endpoint definition
    Chronic graft vs host disease is defined in APPENDIX III of study protocol.
    time origin
    At 2 years
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    2 ineligible patients on experimental arm excluded from analysis. Definition of Chronic GVHD: APPENDIX III: DEFINING CHRONIC GRAFT VS. HOST DISEASE (FROM BMT CTN MOP SEPT. 2005) on page 97 protocol.
    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
    NCT00382109
    outcome key
    om-0005
    source section id
    NCT00382109-om-0005
    source outcome index
    5
    endpoint
    Relative Contribution of Resistance by Acute Lymphoblastic Leukemia (ALL) Blasts to Cytolytic Therapy (e.g., Chemotherapy/Irradiation) as a Cause of Relapse Post-transplantation
    endpoint definition
    An event is defined as relapse or transplant-related mortality.
    time origin
    Up to 1 year
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    We made a large number of xenograft models but were not able to correlate resistance to rapamycin in mice with outcome on the trial with the numbers that we had. For this reason, no specific publications addressing this aim were put forward.
    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
    NCT00382109
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Experimental
    regimen
    Tacro-MTX/Sirolimus GVHD Prophylaxis
    analyzed count
    74
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00382109-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia-pediatric
    nct id
    NCT00382109
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Control
    regimen
    Tacro-MTX GVHD Prophylaxis
    analyzed count
    70
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00382109-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia-pediatric
    nct id
    NCT00382109
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Experimental
    regimen
    Tacro-MTX/Sirolimus GVHD Prophylaxis
    analyzed count
    74
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00382109-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia-pediatric
    nct id
    NCT00382109
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Control
    regimen
    Tacro-MTX GVHD Prophylaxis
    analyzed count
    70
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00382109-om-0001#groups/OG001
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia-pediatric
    nct id
    NCT00382109
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Experimental
    regimen
    Tacro-MTX/Sirolimus GVHD Prophylaxis
    analyzed count
    74
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00382109-om-0002#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia-pediatric
    nct id
    NCT00382109
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Control
    regimen
    Tacro-MTX GVHD Prophylaxis
    analyzed count
    70
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00382109-om-0002#groups/OG001
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia-pediatric
    nct id
    NCT00382109
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Experiemental
    regimen
    Tacro-MTX/Sirolimus GVHD Prophylaxis
    analyzed count
    74
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00382109-om-0003#groups/OG000
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia-pediatric
    nct id
    NCT00382109
    outcome key
    om-0003
    arm key
    OG001
    arm label
    Control
    regimen
    Tacro-MTX GVHD Prophylaxis
    analyzed count
    70
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00382109-om-0003#groups/OG001
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia-pediatric
    nct id
    NCT00382109
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Experimental
    regimen
    Tacro-MTX/Sirolimus GVHD Prophylaxis
    analyzed count
    74
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00382109-om-0004#groups/OG000
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia-pediatric
    nct id
    NCT00382109
    outcome key
    om-0004
    arm key
    OG001
    arm label
    Control
    regimen
    Tacro-MTX GVHD Prophylaxis
    analyzed count
    70
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00382109-om-0004#groups/OG001
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia-pediatric
    nct id
    NCT00382109
    outcome key
    om-0005
    arm key
    OG000
    arm label
    Experiemental
    regimen
    Tacro-MTX/Sirolimus GVHD Prophylaxis
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00382109-om-0005#groups/OG000
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia-pediatric
    nct id
    NCT00382109
    outcome key
    om-0005
    arm key
    OG001
    arm label
    Control
    regimen
    Tacro-MTX GVHD Prophylaxis
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00382109-om-0005#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia-pediatric
    nct id
    NCT00382109
    harm key
    EG000
    source section id
    NCT00382109-ae
    event group key
    EG000
    event group label
    Tacro-MTX/Sirolimus GVHD Prophylaxis Regimen
    serious affected
    9
    serious at risk
    72
    other affected
    38
    other at risk
    72
    frequency threshold
    0
    collection period
    Source null
    event definition
    SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). This study did not collect information about grade 1 and 2 AEs. The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. 4 experimental patients were excluded (2 ineligible, 2 no data).
    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
    NCT00382109
    harm key
    EG001
    source section id
    NCT00382109-ae
    event group key
    EG001
    event group label
    Tacro-MTX GVHD Prophylaxis
    serious affected
    5
    serious at risk
    70
    other affected
    30
    other at risk
    70
    frequency threshold
    0
    collection period
    Source null
    event definition
    SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). This study did not collect information about grade 1 and 2 AEs. The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. 4 experimental patients were excluded (2 ineligible, 2 no data).
    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