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← Childhood Acute Myeloid Leukemia

NCT00445744 · STUDY IN CONTEXT

Cyclophosphamide and Busulfan Followed by Donor Stem Cell Transplant in Treating Patients With Myelofibrosis, Acute Myeloid Leukemia, or Myelodysplastic Syndrome

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 by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

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

Number of patients with regimen-related liver toxicity. Diagnoses will be made according to the established criteria initially proposed in 1984 by McDonald et al.

Source null

→

primary · POSTED

Cumulative incidence rate with death as a competing risk, assessed at day 100.

Source null

→

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-myeloid-leukemia-pediatric
nct id
NCT00445744
trial label
Cyclophosphamide and Busulfan Followed by Donor Stem Cell Transplant in Treating Patients With Myelofibrosis, Acute Myeloid Leukemia, or Myelodysplastic Syndrome
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
registry-condition-search
discovery note
Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count
2
harms Count
1
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-myeloid-leukemia-pediatric
    nct id
    NCT00445744
    outcome key
    om-0000
    source section id
    NCT00445744-om-0000
    source outcome index
    0
    endpoint
    Effectiveness of Cyclophosphamide/Busulfan Regimen in Reducing Regimen-related Liver Toxicity
    endpoint definition
    Number of patients with regimen-related liver toxicity. Diagnoses will be made according to the established criteria initially proposed in 1984 by McDonald et al.
    time origin
    Up to day +20
    analysis role
    primary
    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
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-myeloid-leukemia-pediatric
    nct id
    NCT00445744
    outcome key
    om-0001
    source section id
    NCT00445744-om-0001
    source outcome index
    1
    endpoint
    Non-relapse Mortality (NRM) (Patients With AML/MDS)
    endpoint definition
    Cumulative incidence rate with death as a competing risk, assessed at day 100.
    time origin
    Up to day 200
    analysis role
    primary
    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
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-myeloid-leukemia-pediatric
    nct id
    NCT00445744
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Treatment (Cyclophosphamide, Busulfan, Transplant)
    regimen
    CONDITIONING REGIMEN: Patients receive cyclophosphamide IV on days -7 and -6 and busulfan IV over 3 hours on days -5 to -2. TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell transplant on day 0. POST-TRANSPLANT IMMUNOSUPPRESSION: Patients receive tacrolimus IV or PO twice daily on days -1 to 200 with taper on day 56 and methotrexate on days 1, 3, 6, and 11. cyclophosphamide: Given IV busulfan: Given IV tacrolimus: Given IV or PO methotrexate: Given IV cytogenetic analysis: Correlative studies flow cytometry: Correlative studies pharmacological study: Correlative studies pharmacogenomic studies: Correlative studies peripheral blood stem cell transplantation: Undergo PBPC transplantation allogeneic hematopoietic stem cell transplantation: Undergo allogeneic transplantation
    analyzed count
    51
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00445744-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-myeloid-leukemia-pediatric
    nct id
    NCT00445744
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Treatment (Cyclophosphamide, Busulfan, Transplant)
    regimen
    CONDITIONING REGIMEN: Patients receive cyclophosphamide IV on days -7 and -6 and busulfan IV over 3 hours on days -5 to -2. TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell transplant on day 0. POST-TRANSPLANT IMMUNOSUPPRESSION: Patients receive tacrolimus IV or PO twice daily on days -1 to 200 with taper on day 56 and methotrexate on days 1, 3, 6, and 11. cyclophosphamide: Given IV busulfan: Given IV tacrolimus: Given IV or PO methotrexate: Given IV cytogenetic analysis: Correlative studies flow cytometry: Correlative studies pharmacological study: Correlative studies pharmacogenomic studies: Correlative studies peripheral blood stem cell transplantation: Undergo PBPC transplantation allogeneic hematopoietic stem cell transplantation: Undergo allogeneic transplantation
    analyzed count
    31
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00445744-om-0001#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-myeloid-leukemia-pediatric
    nct id
    NCT00445744
    harm key
    EG000
    source section id
    NCT00445744-ae
    event group key
    EG000
    event group label
    Treatment (Cyclophosphamide, Busulfan, Transplant)
    serious affected
    19
    serious at risk
    52
    other affected
    0
    other at risk
    0
    frequency threshold
    5
    collection period
    Up to 3 years after enrollment
    event definition
    Causes of death were recorded as adverse events. Other adverse events were not recorded in this study.
    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