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NCT03912064 · OUTCOME

Severity of Acute GVHD Rates

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Day 92

What was measured

Severity of aGVHD will be measured at the below time point, and grading severity of aGVHD will be standardized using the chart and information in Appendix C per Harris et al, 2016 "GVHD Target Organ Staging", where 0 is no GVHD and 4 is severe. For the data table below: Grade I-IV reports any incidence of aGVHD, Grade II-IV reports the number of subjects who developed grade II, III, and IV aGVHD and Grade III-IV reports the number of subjects who developed Grade III and IV aGHVD. Grade 0: No stage 1-4 of any organ. Grade I: Stage 1-2 skin without liver, upper GI, or lower GI involvement. Grade II: Stage 3 rash and/or stage 1 liver and/or stage 1 upper GI and/or stage 1 lower GI. Grade III: Stage 2-3 liver and/or stage 2-3 lower GI, with stage 0-3 skin and/or stage 0-1 upper GI. Grade IV: Stage 4 skin, liver, or lower GI involvement, with stage 0-1 upper GI.

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

Grade I-IV aGVHD
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Level: 02Not reportedNot reportedNot reportedNot reported
Dose Level: 12Not reportedNot reportedNot reportedNot reported
Dose Level: 21Not reportedNot reportedNot reportedNot reported
Grade II-IV aGVHD
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Level: 00Not reportedNot reportedNot reportedNot reported
Dose Level: 11Not reportedNot reportedNot reportedNot reported
Dose Level: 20Not reportedNot reportedNot reportedNot reported
Grade III-IV aGVHD
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Level: 02Not reportedNot reportedNot reportedNot reported
Dose Level: 11Not reportedNot reportedNot reportedNot reported
Dose Level: 21Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        1
    title
    Grade I-IV aGVHD
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        0
    title
    Grade II-IV aGVHD
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        1
    title
    Grade III-IV aGVHD
denoms
  1. counts
    1. group Id
      OG000
      value
      18
    2. group Id
      OG001
      value
      6
    3. group Id
      OG002
      value
      1
    units
    Participants
description
Severity of aGVHD will be measured at the below time point, and grading severity of aGVHD will be standardized using the chart and information in Appendix C per Harris et al, 2016 "GVHD Target Organ Staging", where 0 is no GVHD and 4 is severe. For the data table below: Grade I-IV reports any incidence of aGVHD, Grade II-IV reports the number of subjects who developed grade II, III, and IV aGVHD and Grade III-IV reports the number of subjects who developed Grade III and IV aGHVD. Grade 0: No stage 1-4 of any organ. Grade I: Stage 1-2 skin without liver, upper GI, or lower GI involvement. Grade II: Stage 3 rash and/or stage 1 liver and/or stage 1 upper GI and/or stage 1 lower GI. Grade III: Stage 2-3 liver and/or stage 2-3 lower GI, with stage 0-3 skin and/or stage 0-1 upper GI. Grade IV: Stage 4 skin, liver, or lower GI involvement, with stage 0-1 upper GI.
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
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
Day 92
title
Severity of Acute GVHD Rates
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice