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NCT00860574 · STUDY IN CONTEXT

Treosulfan, Fludarabine Phosphate, and Total-Body Irradiation Before Donor Stem Cell Transplant in Treating Patients With High-Risk Acute Myeloid Leukemia, Myelodysplastic Syndrome

Draft scope assessment: unclear. Attached because the study's own record describes recurrent disease. 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

Relapse Incidence

Source null

→

primary · POSTED

Cumulative incidence of NRM at 6 months. NRM includes all deaths without relapse or disease progression.

Source null

→

secondary · POSTED

Non Relapse Mortality Incidence

Source null

→

secondary · POSTED

Overall Survival (OS)

Source null

→

secondary · POSTED

Relapse-free Survival

Source null

→

secondary · POSTED

Incidence of Grades II-IV Acute GVHD

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-lymphoblastic-leukemia-arranon-a85b0386
nct id
NCT00860574
trial label
Treosulfan, Fludarabine Phosphate, and Total-Body Irradiation Before Donor Stem Cell Transplant in Treating Patients With High-Risk Acute Myeloid Leukemia, Myelodysplastic Syndrome
applicability
unclear
applicability note
Attached because the study's own record describes recurrent disease. 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-lymphoblastic-leukemia-arranon-a85b0386
    nct id
    NCT00860574
    outcome key
    om-0000
    source section id
    NCT00860574-om-0000
    source outcome index
    0
    endpoint
    Relapse Incidence
    endpoint definition
    Relapse Incidence
    time origin
    At 6 months
    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-lymphoblastic-leukemia-arranon-a85b0386
    nct id
    NCT00860574
    outcome key
    om-0001
    source section id
    NCT00860574-om-0001
    source outcome index
    1
    endpoint
    Non Relapse Mortality (NRM) Incidence
    endpoint definition
    Cumulative incidence of NRM at 6 months. NRM includes all deaths without relapse or disease progression.
    time origin
    At 6 months
    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
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia-arranon-a85b0386
    nct id
    NCT00860574
    outcome key
    om-0002
    source section id
    NCT00860574-om-0002
    source outcome index
    2
    endpoint
    Non Relapse Mortality Incidence
    endpoint definition
    Non Relapse Mortality Incidence
    time origin
    1 year after HCT
    analysis role
    secondary
    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
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia-arranon-a85b0386
    nct id
    NCT00860574
    outcome key
    om-0003
    source section id
    NCT00860574-om-0003
    source outcome index
    3
    endpoint
    Overall Survival (OS)
    endpoint definition
    Overall Survival (OS)
    time origin
    at 2 years
    analysis role
    secondary
    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
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia-arranon-a85b0386
    nct id
    NCT00860574
    outcome key
    om-0004
    source section id
    NCT00860574-om-0004
    source outcome index
    4
    endpoint
    Relapse-free Survival
    endpoint definition
    Relapse-free Survival
    time origin
    at 2 years
    analysis role
    secondary
    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
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia-arranon-a85b0386
    nct id
    NCT00860574
    outcome key
    om-0005
    source section id
    NCT00860574-om-0005
    source outcome index
    5
    endpoint
    Incidence of Grades II-IV Acute GVHD
    endpoint definition
    Incidence of Grades II-IV Acute GVHD
    time origin
    at 6 months
    analysis role
    secondary
    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-lymphoblastic-leukemia-arranon-a85b0386
    nct id
    NCT00860574
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Treatment (Allogeneic Transplantation)
    regimen
    CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -6 to day -2 and treosulfan IV over 2 hours on days -6 to day -4. Patients also undergo total-body irradiation on day 0. TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell transplantation or bone marrow transplantation on day 0. GVHD PROPHYLAXIS: Patients receive tacrolimus IV continuously or PO BID on days -1 to 56, followed by a taper until day 180 in the absence of GVHD. Patients also receive methotrexate IV on days 1, 3, 6, and 11. treosulfan: Given IV fludarabine phosphate: Given IV total-body irradiation: Low dose starting at 2Gy peripheral blood stem cell transplantation: Given IV per institutional standard practice tacrolimus: Given IV or PO allogeneic bone marrow transplantation: Given IV per institutional standard practice allogeneic hematopoietic stem cell transplantation: Given IV per institutional standard practice methotrexate: Given IV
    analyzed count
    96
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00860574-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia-arranon-a85b0386
    nct id
    NCT00860574
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Treatment (Allogeneic Transplantation)
    regimen
    CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -6 to day -2 and treosulfan IV over 2 hours on days -6 to day -4. Patients also undergo total-body irradiation on day 0. TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell transplantation or bone marrow transplantation on day 0. GVHD PROPHYLAXIS: Patients receive tacrolimus IV continuously or PO BID on days -1 to 56, followed by a taper until day 180 in the absence of GVHD. Patients also receive methotrexate IV on days 1, 3, 6, and 11. treosulfan: Given IV fludarabine phosphate: Given IV total-body irradiation: Low dose starting at 2Gy peripheral blood stem cell transplantation: Given IV per institutional standard practice tacrolimus: Given IV or PO allogeneic bone marrow transplantation: Given IV per institutional standard practice allogeneic hematopoietic stem cell transplantation: Given IV per institutional standard practice methotrexate: Given IV
    analyzed count
    96
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00860574-om-0001#groups/OG000
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia-arranon-a85b0386
    nct id
    NCT00860574
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Treatment (Allogeneic Transplantation)
    regimen
    CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -6 to day -2 and treosulfan IV over 2 hours on days -6 to day -4. Patients also undergo total-body irradiation on day 0. TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell transplantation or bone marrow transplantation on day 0. GVHD PROPHYLAXIS: Patients receive tacrolimus IV continuously or PO BID on days -1 to 56, followed by a taper until day 180 in the absence of GVHD. Patients also receive methotrexate IV on days 1, 3, 6, and 11. treosulfan: Given IV fludarabine phosphate: Given IV total-body irradiation: Low dose starting at 2Gy peripheral blood stem cell transplantation: Given IV per institutional standard practice tacrolimus: Given IV or PO allogeneic bone marrow transplantation: Given IV per institutional standard practice allogeneic hematopoietic stem cell transplantation: Given IV per institutional standard practice methotrexate: Given IV
    analyzed count
    96
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00860574-om-0002#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia-arranon-a85b0386
    nct id
    NCT00860574
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Treatment (Allogeneic Transplantation)
    regimen
    CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -6 to day -2 and treosulfan IV over 2 hours on days -6 to day -4. Patients also undergo total-body irradiation on day 0. TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell transplantation or bone marrow transplantation on day 0. GVHD PROPHYLAXIS: Patients receive tacrolimus IV continuously or PO BID on days -1 to 56, followed by a taper until day 180 in the absence of GVHD. Patients also receive methotrexate IV on days 1, 3, 6, and 11. treosulfan: Given IV fludarabine phosphate: Given IV total-body irradiation: Low dose starting at 2Gy peripheral blood stem cell transplantation: Given IV per institutional standard practice tacrolimus: Given IV or PO allogeneic bone marrow transplantation: Given IV per institutional standard practice allogeneic hematopoietic stem cell transplantation: Given IV per institutional standard practice methotrexate: Given IV
    analyzed count
    96
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00860574-om-0003#groups/OG000
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia-arranon-a85b0386
    nct id
    NCT00860574
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Treatment (Allogeneic Transplantation)
    regimen
    CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -6 to day -2 and treosulfan IV over 2 hours on days -6 to day -4. Patients also undergo total-body irradiation on day 0. TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell transplantation or bone marrow transplantation on day 0. GVHD PROPHYLAXIS: Patients receive tacrolimus IV continuously or PO BID on days -1 to 56, followed by a taper until day 180 in the absence of GVHD. Patients also receive methotrexate IV on days 1, 3, 6, and 11. treosulfan: Given IV fludarabine phosphate: Given IV total-body irradiation: Low dose starting at 2Gy peripheral blood stem cell transplantation: Given IV per institutional standard practice tacrolimus: Given IV or PO allogeneic bone marrow transplantation: Given IV per institutional standard practice allogeneic hematopoietic stem cell transplantation: Given IV per institutional standard practice methotrexate: Given IV
    analyzed count
    96
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00860574-om-0004#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia-arranon-a85b0386
    nct id
    NCT00860574
    outcome key
    om-0005
    arm key
    OG000
    arm label
    Treatment (Allogeneic Transplantation)
    regimen
    CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -6 to day -2 and treosulfan IV over 2 hours on days -6 to day -4. Patients also undergo total-body irradiation on day 0. TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell transplantation or bone marrow transplantation on day 0. GVHD PROPHYLAXIS: Patients receive tacrolimus IV continuously or PO BID on days -1 to 56, followed by a taper until day 180 in the absence of GVHD. Patients also receive methotrexate IV on days 1, 3, 6, and 11. treosulfan: Given IV fludarabine phosphate: Given IV total-body irradiation: Low dose starting at 2Gy peripheral blood stem cell transplantation: Given IV per institutional standard practice tacrolimus: Given IV or PO allogeneic bone marrow transplantation: Given IV per institutional standard practice allogeneic hematopoietic stem cell transplantation: Given IV per institutional standard practice methotrexate: Given IV
    analyzed count
    96
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00860574-om-0005#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia-arranon-a85b0386
    nct id
    NCT00860574
    harm key
    EG000
    source section id
    NCT00860574-ae
    event group key
    EG000
    event group label
    Treatment (Allogeneic Transplantation)
    serious affected
    17
    serious at risk
    96
    other affected
    68
    other at risk
    96
    frequency threshold
    0
    collection period
    Toxicities Before Day 100
    event definition
    Toxicities documented per Common Terminology Criteria for Adverse Events (CTCAE) v3.0
    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