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← Lymphoid Leukemia

NCT00361140 · STUDY IN CONTEXT

Busulfan Safety/Efficacy as Conditioning Prior to Hematopoietic Cell Transplantation (HCT)

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

The number of participants dead due to causes unrelated to relapse within the first 100 days post transplant.

Intent to treat

→

secondary · POSTED

The number of subjects with severe VOD / SOS; severity staged according to criteria set forth by McDonald G.B., Hinds M.S., Fisher L.D., et al. Veno-occlusive disease of the liver and multiorgan failure after bone marrow transplantation: a cohort study of 355 patients. Ann Intern Med. 1993;118:255-267. Assessed within the first 100 days post transplant.

Intent to treat

→

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-lymphoid-leukemia
nct id
NCT00361140
trial label
Busulfan Safety/Efficacy as Conditioning Prior to Hematopoietic Cell Transplantation (HCT)
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
3
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-lymphoid-leukemia
    nct id
    NCT00361140
    outcome key
    om-0001
    source section id
    NCT00361140-om-0001
    source outcome index
    1
    endpoint
    Non-relapse Mortality
    endpoint definition
    The number of participants dead due to causes unrelated to relapse within the first 100 days post transplant.
    time origin
    100 days
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Intent to treat
    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-lymphoid-leukemia
    nct id
    NCT00361140
    outcome key
    om-0000
    source section id
    NCT00361140-om-0000
    source outcome index
    0
    endpoint
    Severe Venous Occlusive Disease (VOD)/ Sinusoidal Obstructive Syndrome (SOS)
    endpoint definition
    The number of subjects with severe VOD / SOS; severity staged according to criteria set forth by McDonald G.B., Hinds M.S., Fisher L.D., et al. Veno-occlusive disease of the liver and multiorgan failure after bone marrow transplantation: a cohort study of 355 patients. Ann Intern Med. 1993;118:255-267. Assessed within the first 100 days post transplant.
    time origin
    100 days
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Intent to treat
    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-lymphoid-leukemia
    nct id
    NCT00361140
    outcome key
    om-0000
    arm key
    OG000
    arm label
    AUC 6000
    regimen
    Busulfan AUC Level 1: 6000 +/- 600 uM-min Fludarabine 40 mg/m\^2 I.V. over 1 hour
    analyzed count
    40
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00361140-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-lymphoid-leukemia
    nct id
    NCT00361140
    outcome key
    om-0000
    arm key
    OG001
    arm label
    AUC 7500
    regimen
    Busulfan AUC Level 2: 7500 +/- 750 uM-min Fludarabine 40 mg/m\^2 I.V. over 1 hour
    analyzed count
    29
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00361140-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-lymphoid-leukemia
    nct id
    NCT00361140
    outcome key
    om-0000
    arm key
    OG002
    arm label
    AUC 9000
    regimen
    Busulfan AUC Level 3: 9000 +/- 900 uM-min Fludarabine 40 mg/m\^2 I.V. over 1 hour
    analyzed count
    3
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00361140-om-0000#groups/OG002
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-lymphoid-leukemia
    nct id
    NCT00361140
    outcome key
    om-0001
    arm key
    OG000
    arm label
    AUC 6000
    regimen
    Busulfan AUC Level 1: 6000 +/- 600 uM-min Fludarabine 40 mg/m\^2 I.V. over 1 hour
    analyzed count
    40
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00361140-om-0001#groups/OG000
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-lymphoid-leukemia
    nct id
    NCT00361140
    outcome key
    om-0001
    arm key
    OG001
    arm label
    AUC 7500
    regimen
    Busulfan AUC Level 2: 7500 +/- 750 uM-min Fludarabine 40 mg/m\^2 I.V. over 1 hour
    analyzed count
    29
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00361140-om-0001#groups/OG001
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-lymphoid-leukemia
    nct id
    NCT00361140
    outcome key
    om-0001
    arm key
    OG002
    arm label
    AUC 9000
    regimen
    Busulfan AUC Level 3: 9000 +/- 900 uM-min Fludarabine 40 mg/m\^2 I.V. over 1 hour
    analyzed count
    3
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00361140-om-0001#groups/OG002
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-lymphoid-leukemia
    nct id
    NCT00361140
    harm key
    EG000
    source section id
    NCT00361140-ae
    event group key
    EG000
    event group label
    AUC Level 1
    serious affected
    2
    serious at risk
    40
    other affected
    0
    other at risk
    40
    frequency threshold
    5
    collection period
    Source null
    event definition
    Anticipated "other than serious" Allogeneic Hematopoietic Cell Transplantation (HCT) adverse events were not tabulated.
    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-lymphoid-leukemia
    nct id
    NCT00361140
    harm key
    EG001
    source section id
    NCT00361140-ae
    event group key
    EG001
    event group label
    AUC Level 2
    serious affected
    13
    serious at risk
    29
    other affected
    0
    other at risk
    29
    frequency threshold
    5
    collection period
    Source null
    event definition
    Anticipated "other than serious" Allogeneic Hematopoietic Cell Transplantation (HCT) adverse events were not tabulated.
    undenominated 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-lymphoid-leukemia
    nct id
    NCT00361140
    harm key
    EG002
    source section id
    NCT00361140-ae
    event group key
    EG002
    event group label
    AUC Level 3
    serious affected
    2
    serious at risk
    3
    other affected
    0
    other at risk
    3
    frequency threshold
    5
    collection period
    Source null
    event definition
    Anticipated "other than serious" Allogeneic Hematopoietic Cell Transplantation (HCT) adverse events were not tabulated.
    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