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← Myeloid Leukemia

NCT00967343 · STUDY IN CONTEXT

Efficacy and Safety of a Donor Lymphocyte Preparation Depleted of Functional Host Alloreactive T-cells (ATIR) in Patients Undergoing a Peripheral Blood Stem Cell Transplant From a

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

TRM is defined as death due to causes other than disease relapse or progression, or other causes which are unrelated to the transplantation procedure (e.g. accident, suicide)

Source null

→

secondary · POSTED

GVHD was graded according to standard criteria as referred to in the reference module (Filipovich et al. 2005; Przepiorka et al. 1995).

Source null

→

secondary · POSTED

Progression Free Survival

Data were not collected, premature termination of study

→

secondary · POSTED

Incidence and Severity of Bacterial, Viral or Fungal Infection

Data not collected, premature termination of study

→

secondary · POSTED

Immune Reconstitution

Data were not collected, premature termination of study

→

secondary · POSTED

Health Status (Including Quality of Life)

Data were not collected, premature termination of study

→

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

Unnamed quality-of-life measure · Health Status (Including Quality of Life)

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-myeloid-leukemia
nct id
NCT00967343
qol key
qol-0005
source section id
NCT00967343-om-0005
source outcome index
5
instrument
Unnamed quality-of-life measure
instrument basis
matched 'quality of life' in the study's own wording
scale title
Health Status (Including Quality of Life)
measure definition
Source null
time frame
Up to 24 months after the transplantation
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
Data were not collected, premature termination of study
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-myeloid-leukemia
nct id
NCT00967343
trial label
Efficacy and Safety of a Donor Lymphocyte Preparation Depleted of Functional Host Alloreactive T-cells (ATIR) in Patients Undergoing a Peripheral Blood Stem Cell Transplant From a
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
6
harms Count
1
qol Count
1
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-myeloid-leukemia
    nct id
    NCT00967343
    outcome key
    om-0000
    source section id
    NCT00967343-om-0000
    source outcome index
    0
    endpoint
    Transplant Related Mortality
    endpoint definition
    TRM is defined as death due to causes other than disease relapse or progression, or other causes which are unrelated to the transplantation procedure (e.g. accident, suicide)
    time origin
    6, 12 and 24 months after the transplantation
    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-myeloid-leukemia
    nct id
    NCT00967343
    outcome key
    om-0001
    source section id
    NCT00967343-om-0001
    source outcome index
    1
    endpoint
    Incidence and Severity Graft-versus-host Disease (GVHD)
    endpoint definition
    GVHD was graded according to standard criteria as referred to in the reference module (Filipovich et al. 2005; Przepiorka et al. 1995).
    time origin
    Up to 24 months after the transplantation
    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
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-myeloid-leukemia
    nct id
    NCT00967343
    outcome key
    om-0002
    source section id
    NCT00967343-om-0002
    source outcome index
    2
    endpoint
    Progression Free Survival
    endpoint definition
    Progression Free Survival
    time origin
    Up to 24 months after the transplantation
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Data were not collected, premature termination of study
    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-myeloid-leukemia
    nct id
    NCT00967343
    outcome key
    om-0003
    source section id
    NCT00967343-om-0003
    source outcome index
    3
    endpoint
    Incidence and Severity of Bacterial, Viral or Fungal Infection
    endpoint definition
    Incidence and Severity of Bacterial, Viral or Fungal Infection
    time origin
    Up to 24 months after the transplantation
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Data not collected, premature termination of study
    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-myeloid-leukemia
    nct id
    NCT00967343
    outcome key
    om-0004
    source section id
    NCT00967343-om-0004
    source outcome index
    4
    endpoint
    Immune Reconstitution
    endpoint definition
    Immune Reconstitution
    time origin
    Up to 24 months after the transplantation
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Data were not collected, premature termination of study
    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-myeloid-leukemia
    nct id
    NCT00967343
    outcome key
    om-0005
    source section id
    NCT00967343-om-0005
    source outcome index
    5
    endpoint
    Health Status (Including Quality of Life)
    endpoint definition
    Health Status (Including Quality of Life)
    time origin
    Up to 24 months after the transplantation
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Data were not collected, premature termination of study
    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-myeloid-leukemia
    nct id
    NCT00967343
    outcome key
    om-0000
    arm key
    OG000
    arm label
    ATIR
    regimen
    Donor lymphocyte preparation depleted of host functional alloreactive T-cells: Single intravenous infusion with 2x10E6 T-cells/kg
    analyzed count
    40
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00967343-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-myeloid-leukemia
    nct id
    NCT00967343
    outcome key
    om-0001
    arm key
    OG000
    arm label
    ATIR
    regimen
    Donor lymphocyte preparation depleted of host functional alloreactive T-cells: Single intravenous infusion with 2x10E6 T-cells/kg
    analyzed count
    40
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00967343-om-0001#groups/OG000
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-myeloid-leukemia
    nct id
    NCT00967343
    outcome key
    om-0002
    arm key
    OG000
    arm label
    ATIR
    regimen
    Donor lymphocyte preparation depleted of host functional alloreactive T-cells: Single intravenous infusion with 2x10E6 T-cells/kg
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00967343-om-0002#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-myeloid-leukemia
    nct id
    NCT00967343
    outcome key
    om-0003
    arm key
    OG000
    arm label
    ATIR
    regimen
    Donor lymphocyte preparation depleted of host functional alloreactive T-cells: Single intravenous infusion with 2x10E6 T-cells/kg
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00967343-om-0003#groups/OG000
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-myeloid-leukemia
    nct id
    NCT00967343
    outcome key
    om-0004
    arm key
    OG000
    arm label
    ATIR
    regimen
    Donor lymphocyte preparation depleted of host functional alloreactive T-cells: Single intravenous infusion with 2x10E6 T-cells/kg
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00967343-om-0004#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-myeloid-leukemia
    nct id
    NCT00967343
    outcome key
    om-0005
    arm key
    OG000
    arm label
    ATIR
    regimen
    Donor lymphocyte preparation depleted of host functional alloreactive T-cells: Single intravenous infusion with 2x10E6 T-cells/kg
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00967343-om-0005#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-myeloid-leukemia
    nct id
    NCT00967343
    harm key
    EG000
    source section id
    NCT00967343-ae
    event group key
    EG000
    event group label
    ATIR
    serious affected
    9
    serious at risk
    40
    other affected
    15
    other at risk
    40
    frequency threshold
    5
    collection period
    Source null
    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
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-myeloid-leukemia
    nct id
    NCT00967343
    qol key
    qol-0005
    source section id
    NCT00967343-om-0005
    source outcome index
    5
    instrument
    Unnamed quality-of-life measure
    instrument basis
    matched 'quality of life' in the study's own wording
    scale title
    Health Status (Including Quality of Life)
    measure definition
    Source null
    time frame
    Up to 24 months after the transplantation
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    Data were not collected, premature termination of study
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
setting source links

    Preserved source evidence · Not medical advice