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← T-Cell Large Granular Lymphocyte Leukemia

NCT01839916 · STUDY IN CONTEXT

Donor T Cells After Donor Stem Cell Transplant in Treating Patients With Hematologic Malignancies

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.

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-t-cell-large-granular-lymphocyte-leukemia
nct id
NCT01839916
trial label
Donor T Cells After Donor Stem Cell Transplant in Treating Patients With Hematologic Malignancies
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
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-t-cell-large-granular-lymphocyte-leukemia
    nct id
    NCT01839916
    outcome key
    om-0000
    source section id
    NCT01839916-om-0000
    source outcome index
    0
    endpoint
    Percentage of Patients Who Are Able to Receive at Least One DLI Treatment
    endpoint definition
    Percentage of Patients Who Are Able to Receive at Least One DLI Treatment
    time origin
    Up to 2 years
    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-t-cell-large-granular-lymphocyte-leukemia
    nct id
    NCT01839916
    outcome key
    om-0001
    source section id
    NCT01839916-om-0001
    source outcome index
    1
    endpoint
    Progression Free Survival (PFS)
    endpoint definition
    Time to relapse or death as a result of any cause was evaluated at 2 years and the progression free survival rate was reported.
    time origin
    2 years
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Patients received at least one DLI Treatment.
    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-t-cell-large-granular-lymphocyte-leukemia
    nct id
    NCT01839916
    outcome key
    om-0002
    source section id
    NCT01839916-om-0002
    source outcome index
    2
    endpoint
    Overall Survival (OS)
    endpoint definition
    Computed using the Kaplan-Meier product-limit estimate and expressed as probabilities with a 95% CI.
    time origin
    At 2 years
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Patients received at least one DLI Treatment.
    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-t-cell-large-granular-lymphocyte-leukemia
    nct id
    NCT01839916
    outcome key
    om-0003
    source section id
    NCT01839916-om-0003
    source outcome index
    3
    endpoint
    Rate of Acute GVHD (aGVHD) With Any Grade
    endpoint definition
    Estimated by cumulative incidence method.
    time origin
    At 1 year and 2 year
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Patients received at least one DLI Treatment.
    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-t-cell-large-granular-lymphocyte-leukemia
    nct id
    NCT01839916
    outcome key
    om-0004
    source section id
    NCT01839916-om-0004
    source outcome index
    4
    endpoint
    Rate of Chronic GVHD (cGVHD)
    endpoint definition
    Estimated by cumulative incidence method.
    time origin
    At 1 year and 2 year
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Patients received at least one DLI treatment.
    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-t-cell-large-granular-lymphocyte-leukemia
    nct id
    NCT01839916
    outcome key
    om-0005
    source section id
    NCT01839916-om-0005
    source outcome index
    5
    endpoint
    Treatment-related Mortality
    endpoint definition
    Estimated by cumulative incidence method. Cumulative incidence of treatment-related mortality with relapse of the original disease as the competing risk will be calculated.
    time origin
    At 2 year
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Patients received at least one DLI treatment.
    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-t-cell-large-granular-lymphocyte-leukemia
    nct id
    NCT01839916
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Treatment (DLI)
    regimen
    Patients receive DLI IV. Treatment repeats every 4-8 weeks for 5 doses in the absence of disease progression or unacceptable toxicity. therapeutic allogeneic lymphocytes: Given IV laboratory biomarker analysis: Correlative studies
    analyzed count
    77
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01839916-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-t-cell-large-granular-lymphocyte-leukemia
    nct id
    NCT01839916
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Treatment (DLI)
    regimen
    Patients receive DLI IV. Treatment repeats every 4-8 weeks for 5 doses in the absence of disease progression or unacceptable toxicity. therapeutic allogeneic lymphocytes: Given IV laboratory biomarker analysis: Correlative studies
    analyzed count
    36
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01839916-om-0001#groups/OG000
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-t-cell-large-granular-lymphocyte-leukemia
    nct id
    NCT01839916
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Treatment (DLI)
    regimen
    Patients receive DLI IV. Treatment repeats every 4-8 weeks for 5 doses in the absence of disease progression or unacceptable toxicity. therapeutic allogeneic lymphocytes: Given IV laboratory biomarker analysis: Correlative studies
    analyzed count
    36
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01839916-om-0002#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-t-cell-large-granular-lymphocyte-leukemia
    nct id
    NCT01839916
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Treatment (DLI)
    regimen
    Patients receive DLI IV. Treatment repeats every 4-8 weeks for 5 doses in the absence of disease progression or unacceptable toxicity. therapeutic allogeneic lymphocytes: Given IV laboratory biomarker analysis: Correlative studies
    analyzed count
    36
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01839916-om-0003#groups/OG000
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-t-cell-large-granular-lymphocyte-leukemia
    nct id
    NCT01839916
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Treatment (DLI)
    regimen
    Patients receive DLI IV. Treatment repeats every 4-8 weeks for 5 doses in the absence of disease progression or unacceptable toxicity. therapeutic allogeneic lymphocytes: Given IV laboratory biomarker analysis: Correlative studies
    analyzed count
    36
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01839916-om-0004#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-t-cell-large-granular-lymphocyte-leukemia
    nct id
    NCT01839916
    outcome key
    om-0005
    arm key
    OG000
    arm label
    Treatment (DLI)
    regimen
    Patients receive DLI IV. Treatment repeats every 4-8 weeks for 5 doses in the absence of disease progression or unacceptable toxicity. therapeutic allogeneic lymphocytes: Given IV laboratory biomarker analysis: Correlative studies
    analyzed count
    36
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01839916-om-0005#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-t-cell-large-granular-lymphocyte-leukemia
    nct id
    NCT01839916
    harm key
    EG000
    source section id
    NCT01839916-ae
    event group key
    EG000
    event group label
    Treatment (DLI)
    serious affected
    12
    serious at risk
    36
    other affected
    1
    other at risk
    36
    frequency threshold
    0
    collection period
    2 year
    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