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← VANFLYTA: acute myeloid leukemia with FLT3 stated without a specific alteration (maintenance) after prior therapy

NCT03333486 · STUDY IN CONTEXT

Fludarabine Phosphate, Cyclophosphamide, Total Body Irradiation, and Donor Stem Cell Transplant in Treating Patients With Blood Cancer

Draft scope assessment: unclear. Attached because the study's own record names FLT3. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. 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

The number of participants that relapse within 1 year.

All treated and eligible patients

→

secondary · POSTED

Absolute Neutrophil Count Engraftment rate was defined as the number of participants that received an engraftment within 1 year post-transplant and ANC \> 0.5x10\^9/L for three consecutive days, out of the total number of participants. The rate was computed with corresponding exact 95% confidence intervals based on the methodology of Clopper and Pearson.

All treated and eligible patients

→

secondary · POSTED

Platelet Engraftment rate was defined as the number of participants that received an engraftment within 1 year post-transplant and the platelets \>= 20 x 10\^9/L after 7 consecutive days with no platelet transfusions, out of the total number of participants. The rate was computed with corresponding exact 95% confidence intervals based on the methodology of Clopper and Pearson.

All treated and eligible patients

→

secondary · POSTED

Will be computed with corresponding exact 95% confidence intervals based on the methodology of Clopper and Pearson.

All treated and eligible patients

→

secondary · POSTED

Will be computed with corresponding exact 95% confidence intervals based on the methodology of Clopper and Pearson.

All treated and eligible patients

→

secondary · POSTED

Will be computed with corresponding exact 95% confidence intervals based on the methodology of Clopper and Pearson. Will be obtained using the product-limit based Kaplan-Meier method.

All treated and eligible patients

→

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-vanflyta-dab15417
nct id
NCT03333486
trial label
Fludarabine Phosphate, Cyclophosphamide, Total Body Irradiation, and Donor Stem Cell Transplant in Treating Patients With Blood Cancer
applicability
unclear
applicability note
Attached because the study's own record names FLT3. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
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
6
harms Count
1
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-myeloid-leukemia-vanflyta-dab15417
    nct id
    NCT03333486
    outcome key
    om-0000
    source section id
    NCT03333486-om-0000
    source outcome index
    0
    endpoint
    Relapse Rate
    endpoint definition
    The number of participants that relapse within 1 year.
    time origin
    At 1 year
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All treated and eligible patients
    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-vanflyta-dab15417
    nct id
    NCT03333486
    outcome key
    om-0001
    source section id
    NCT03333486-om-0001
    source outcome index
    1
    endpoint
    ANC Engraftment Rate, the Percentage of Participants That Had a Successful Engraftment
    endpoint definition
    Absolute Neutrophil Count Engraftment rate was defined as the number of participants that received an engraftment within 1 year post-transplant and ANC \> 0.5x10\^9/L for three consecutive days, out of the total number of participants. The rate was computed with corresponding exact 95% confidence intervals based on the methodology of Clopper and Pearson.
    time origin
    At 1 year post-transplant
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All treated and eligible patients
    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-myeloid-leukemia-vanflyta-dab15417
    nct id
    NCT03333486
    outcome key
    om-0002
    source section id
    NCT03333486-om-0002
    source outcome index
    2
    endpoint
    Platelet Engraftment Rate, the Percentage of Participants That Had a Successful Engraftment
    endpoint definition
    Platelet Engraftment rate was defined as the number of participants that received an engraftment within 1 year post-transplant and the platelets \>= 20 x 10\^9/L after 7 consecutive days with no platelet transfusions, out of the total number of participants. The rate was computed with corresponding exact 95% confidence intervals based on the methodology of Clopper and Pearson.
    time origin
    At 1 year post-transplant
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All treated and eligible patients
    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-myeloid-leukemia-vanflyta-dab15417
    nct id
    NCT03333486
    outcome key
    om-0003
    source section id
    NCT03333486-om-0003
    source outcome index
    3
    endpoint
    Proportion of Participants With Acute Graft Versus Host Disease (GVHD)
    endpoint definition
    Will be computed with corresponding exact 95% confidence intervals based on the methodology of Clopper and Pearson.
    time origin
    At 100 days post-transplant
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All treated and eligible patients
    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-myeloid-leukemia-vanflyta-dab15417
    nct id
    NCT03333486
    outcome key
    om-0004
    source section id
    NCT03333486-om-0004
    source outcome index
    4
    endpoint
    Proportion of Participants With Chronic Graft Versus Host Disease (GVHD)
    endpoint definition
    Will be computed with corresponding exact 95% confidence intervals based on the methodology of Clopper and Pearson.
    time origin
    At 1 year post-transplant
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All treated and eligible patients
    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-myeloid-leukemia-vanflyta-dab15417
    nct id
    NCT03333486
    outcome key
    om-0005
    source section id
    NCT03333486-om-0005
    source outcome index
    5
    endpoint
    Overall Survival
    endpoint definition
    Will be computed with corresponding exact 95% confidence intervals based on the methodology of Clopper and Pearson. Will be obtained using the product-limit based Kaplan-Meier method.
    time origin
    up to 5 years and 8 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All treated and eligible patients
    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-vanflyta-dab15417
    nct id
    NCT03333486
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Treatment (Fludarabine, Cyclophosphamide, TBI, PBSCT)
    regimen
    Patients receive fludarabine phosphate IV over 30 minutes on days -6 to -2 and cyclophosphamide IV over 2 hours on days -6 and -5. Patients undergo TBI on days -1 and PBSCT on day 0. Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Laboratory Biomarker Analysis: Correlative studies Peripheral Blood Stem Cell Transplantation: Undergo PBSCT Total-Body Irradiation: Undergo TBI
    analyzed count
    31
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03333486-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-myeloid-leukemia-vanflyta-dab15417
    nct id
    NCT03333486
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Treatment (Fludarabine, Cyclophosphamide, TBI, PBSCT)
    regimen
    Patients receive fludarabine phosphate IV over 30 minutes on days -6 to -2 and cyclophosphamide IV over 2 hours on days -6 and -5. Patients undergo TBI on days -1 and PBSCT on day 0. Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Laboratory Biomarker Analysis: Correlative studies Peripheral Blood Stem Cell Transplantation: Undergo PBSCT Total-Body Irradiation: Undergo TBI
    analyzed count
    31
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03333486-om-0001#groups/OG000
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-myeloid-leukemia-vanflyta-dab15417
    nct id
    NCT03333486
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Treatment (Fludarabine, Cyclophosphamide, TBI, PBSCT)
    regimen
    Patients receive fludarabine phosphate IV over 30 minutes on days -6 to -2 and cyclophosphamide IV over 2 hours on days -6 and -5. Patients undergo TBI on days -1 and PBSCT on day 0. Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Laboratory Biomarker Analysis: Correlative studies Peripheral Blood Stem Cell Transplantation: Undergo PBSCT Total-Body Irradiation: Undergo TBI
    analyzed count
    31
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03333486-om-0002#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-myeloid-leukemia-vanflyta-dab15417
    nct id
    NCT03333486
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Treatment (Fludarabine, Cyclophosphamide, TBI, PBSCT)
    regimen
    Patients receive fludarabine phosphate IV over 30 minutes on days -6 to -2 and cyclophosphamide IV over 2 hours on days -6 and -5. Patients undergo TBI on days -1 and PBSCT on day 0. Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Laboratory Biomarker Analysis: Correlative studies Peripheral Blood Stem Cell Transplantation: Undergo PBSCT Total-Body Irradiation: Undergo TBI
    analyzed count
    31
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03333486-om-0003#groups/OG000
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-myeloid-leukemia-vanflyta-dab15417
    nct id
    NCT03333486
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Treatment (Fludarabine, Cyclophosphamide, TBI, PBSCT)
    regimen
    Patients receive fludarabine phosphate IV over 30 minutes on days -6 to -2 and cyclophosphamide IV over 2 hours on days -6 and -5. Patients undergo TBI on days -1 and PBSCT on day 0. Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Laboratory Biomarker Analysis: Correlative studies Peripheral Blood Stem Cell Transplantation: Undergo PBSCT Total-Body Irradiation: Undergo TBI
    analyzed count
    31
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03333486-om-0004#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-myeloid-leukemia-vanflyta-dab15417
    nct id
    NCT03333486
    outcome key
    om-0005
    arm key
    OG000
    arm label
    Treatment (Fludarabine, Cyclophosphamide, TBI, PBSCT)
    regimen
    Patients receive fludarabine phosphate IV over 30 minutes on days -6 to -2 and cyclophosphamide IV over 2 hours on days -6 and -5. Patients undergo TBI on days -1 and PBSCT on day 0. Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Laboratory Biomarker Analysis: Correlative studies Peripheral Blood Stem Cell Transplantation: Undergo PBSCT Total-Body Irradiation: Undergo TBI
    analyzed count
    31
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03333486-om-0005#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-myeloid-leukemia-vanflyta-dab15417
    nct id
    NCT03333486
    harm key
    EG000
    source section id
    NCT03333486-ae
    event group key
    EG000
    event group label
    Treatment (Fludarabine, Cyclophosphamide, TBI, PBSCT)
    serious affected
    8
    serious at risk
    31
    other affected
    27
    other at risk
    31
    frequency threshold
    0
    collection period
    5 years and 8.5 months
    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