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NCT03912064 · OUTCOME

Progression Free Survival

A Phase 1 Trial of CD25/Treg-depleted DLI Plus Ipilimumab for Myeloid Disease Relapse After Matched-HCT · Source last updated 2026-01-05

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
Day 92 and Week 60

What was measured

Duration of time from start of treatment to time of objective disease progression or death, whichever comes first. AML progressive disease is defined in Appendix E (E.1.7.), and criteria for MDS/MPN is in Appendix F (F.1.4.).

Groups in this outcome

Dose Level: 0

1 mg/kg of Ipilimumab and 3x10\^7 CD3+ cells/kg of CD25/Treg-depleted DLI will be administered intravenously over 90 ± 10 minutes after the DLI product observation period is completed, and dosing will continue in 3-week intervals for 4 cycles, unless unacceptable toxicity or symptomatic disease progression occurs.

Dose Level: 1

3 mg/kg of Ipilimumab and 3x10\^7 CD3+ cells/kg of CD25/Treg-depleted DLI will be administered intravenously over 90 ± 10 minutes after the DLI product observation period is completed, and dosing will continue in 3-week intervals for 4 cycles, unless unacceptable toxicity or symptomatic disease progression occurs.

Dose Level: 2

10 mg/kg of Ipilimumab and 3x10\^7 CD3+ cells/kg of CD25/Treg-depleted DLI will be administered intravenously over 90 ± 10 minutes after the DLI product observation period is completed, and dosing will continue in 3-week intervals for 4 cycles, unless unacceptable toxicity or symptomatic disease progression occurs.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Dose Level: 018
Dose Level: 16
Dose Level: 21

Reported measurements

Day 92
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Dose Level: 050Not reported2773Not reported
Dose Level: 183Not reported53100Not reported
Dose Level: 2NANot reportedNANAProgression event (died without progression) at day 65, Sample size too small to estimate the rate and CI
Week 60
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Dose Level: 033Not reported1155Not reported
Dose Level: 117Not reported047Not reported
Dose Level: 2NANot reportedNANAProgression event (died without progression) at day 65, Sample size too small to estimate the rate and CI
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        27
        upper Limit
        73
        value
        50
      2. group Id
        OG001
        lower Limit
        53
        upper Limit
        100
        value
        83
      3. comment
        Progression event (died without progression) at day 65, Sample size too small to estimate the rate and CI
        group Id
        OG002
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
    title
    Day 92
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        11
        upper Limit
        55
        value
        33
      2. group Id
        OG001
        lower Limit
        0
        upper Limit
        47
        value
        17
      3. comment
        Progression event (died without progression) at day 65, Sample size too small to estimate the rate and CI
        group Id
        OG002
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
    title
    Week 60
denoms
  1. counts
    1. group Id
      OG000
      value
      18
    2. group Id
      OG001
      value
      6
    3. group Id
      OG002
      value
      1
    units
    Participants
description
Duration of time from start of treatment to time of objective disease progression or death, whichever comes first. AML progressive disease is defined in Appendix E (E.1.7.), and criteria for MDS/MPN is in Appendix F (F.1.4.).
dispersion Type
95% Confidence Interval
groups
  1. description
    1 mg/kg of Ipilimumab and 3x10\^7 CD3+ cells/kg of CD25/Treg-depleted DLI will be administered intravenously over 90 ± 10 minutes after the DLI product observation period is completed, and dosing will continue in 3-week intervals for 4 cycles, unless unacceptable toxicity or symptomatic disease progression occurs.
    id
    OG000
    title
    Dose Level: 0
  2. description
    3 mg/kg of Ipilimumab and 3x10\^7 CD3+ cells/kg of CD25/Treg-depleted DLI will be administered intravenously over 90 ± 10 minutes after the DLI product observation period is completed, and dosing will continue in 3-week intervals for 4 cycles, unless unacceptable toxicity or symptomatic disease progression occurs.
    id
    OG001
    title
    Dose Level: 1
  3. description
    10 mg/kg of Ipilimumab and 3x10\^7 CD3+ cells/kg of CD25/Treg-depleted DLI will be administered intravenously over 90 ± 10 minutes after the DLI product observation period is completed, and dosing will continue in 3-week intervals for 4 cycles, unless unacceptable toxicity or symptomatic disease progression occurs.
    id
    OG002
    title
    Dose Level: 2
param Type
NUMBER
reporting Status
POSTED
time Frame
Day 92 and Week 60
title
Progression Free Survival
type
SECONDARY
unit Of Measure
percentage of participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice