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← Prolymphocytic Leukemia

NCT02991898 · STUDY IN CONTEXT

Adoptive TReg Cell for Suppression of aGVHD After UCB HSCT for Heme 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.

primary · POSTED

Count of patients who survived 2 years post intervention

Source null

→

secondary · POSTED

Probability of grade II-IV aGVHD

Source null

→

secondary · POSTED

Evaluated with descriptive statistics and plots or cumulative incidence curves if enough evaluable patients are available for time-to-event endpoints.

Source null

→

secondary · POSTED

Evaluated with descriptive statistics and plots or cumulative incidence curves if enough evaluable patients are available for time-to-event endpoints.

Source null

→

secondary · POSTED

Evaluated with descriptive statistics and plots or cumulative incidence curves if enough evaluable patients are available for time-to-event endpoints.

Source null

→

secondary · POSTED

The proportion of patients with detectable Treg cells at day 14 post infusion

Samples were not analyzed, and so data not available for reporting.

→

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-prolymphocytic-leukemia
nct id
NCT02991898
trial label
Adoptive TReg Cell for Suppression of aGVHD After UCB HSCT for Heme 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-prolymphocytic-leukemia
    nct id
    NCT02991898
    outcome key
    om-0000
    source section id
    NCT02991898-om-0000
    source outcome index
    0
    endpoint
    Number of Participants Survived
    endpoint definition
    Count of patients who survived 2 years post intervention
    time origin
    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-prolymphocytic-leukemia
    nct id
    NCT02991898
    outcome key
    om-0001
    source section id
    NCT02991898-om-0001
    source outcome index
    1
    endpoint
    Number of Participants With Grade II-IV aGVHD
    endpoint definition
    Probability of grade II-IV aGVHD
    time origin
    Assessed weekly until day 100, then day 180, 360
    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-prolymphocytic-leukemia
    nct id
    NCT02991898
    outcome key
    om-0002
    source section id
    NCT02991898-om-0002
    source outcome index
    2
    endpoint
    Number of Participants Experiencing Treatment Related Mortality (TRM)
    endpoint definition
    Evaluated with descriptive statistics and plots or cumulative incidence curves if enough evaluable patients are available for time-to-event endpoints.
    time origin
    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
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-prolymphocytic-leukemia
    nct id
    NCT02991898
    outcome key
    om-0003
    source section id
    NCT02991898-om-0003
    source outcome index
    3
    endpoint
    Number of Participants Who Experienced Relapse
    endpoint definition
    Evaluated with descriptive statistics and plots or cumulative incidence curves if enough evaluable patients are available for time-to-event endpoints.
    time origin
    1 year
    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-prolymphocytic-leukemia
    nct id
    NCT02991898
    outcome key
    om-0004
    source section id
    NCT02991898-om-0004
    source outcome index
    4
    endpoint
    Number of Participants With Incidence of Bacterial, Viral and Fungal Infections
    endpoint definition
    Evaluated with descriptive statistics and plots or cumulative incidence curves if enough evaluable patients are available for time-to-event endpoints.
    time origin
    1 year
    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-prolymphocytic-leukemia
    nct id
    NCT02991898
    outcome key
    om-0005
    source section id
    NCT02991898-om-0005
    source outcome index
    5
    endpoint
    Number of Participant With Detectable Treg Cells at d14
    endpoint definition
    The proportion of patients with detectable Treg cells at day 14 post infusion
    time origin
    14 days
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Samples were not analyzed, and so data not available for reporting.
    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-prolymphocytic-leukemia
    nct id
    NCT02991898
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Treg Infusion
    regimen
    The Treg cell infusion is given no sooner than 1 hour, but within 24 hours after the 2nd cord blood infusion
    analyzed count
    3
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02991898-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-prolymphocytic-leukemia
    nct id
    NCT02991898
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Treg Infusion
    regimen
    The Treg cell infusion is given no sooner than 1 hour, but within 24 hours after the 2nd cord blood infusion
    analyzed count
    3
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02991898-om-0001#groups/OG000
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-prolymphocytic-leukemia
    nct id
    NCT02991898
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Treg Infusion
    regimen
    The Treg cell infusion is given no sooner than 1 hour, but within 24 hours after the 2nd cord blood infusion
    analyzed count
    3
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02991898-om-0002#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-prolymphocytic-leukemia
    nct id
    NCT02991898
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Treg Infusion
    regimen
    The Treg cell infusion is given no sooner than 1 hour, but within 24 hours after the 2nd cord blood infusion
    analyzed count
    3
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02991898-om-0003#groups/OG000
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-prolymphocytic-leukemia
    nct id
    NCT02991898
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Treg Infusion
    regimen
    The Treg cell infusion is given no sooner than 1 hour, but within 24 hours after the 2nd cord blood infusion
    analyzed count
    3
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02991898-om-0004#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-prolymphocytic-leukemia
    nct id
    NCT02991898
    outcome key
    om-0005
    arm key
    OG000
    arm label
    Treg Infusion
    regimen
    The Treg cell infusion is given no sooner than 1 hour, but within 24 hours after the 2nd cord blood infusion
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02991898-om-0005#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-prolymphocytic-leukemia
    nct id
    NCT02991898
    harm key
    EG000
    source section id
    NCT02991898-ae
    event group key
    EG000
    event group label
    Treg Infusion
    serious affected
    2
    serious at risk
    3
    other affected
    2
    other at risk
    3
    frequency threshold
    0
    collection period
    1 week
    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