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NCT03912064 · OUTCOME

Maximum Tolerated Dose (MTD) for DLI

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
cells/kg
Interval / dispersion
Not reported
Time frame
Day 43 (6 weeks)

What was measured

The primary objective of this study is to determine the safety (MTD) of CD25/Treg-depleted donor lymphocyte infusion (DLI) plus Ipilimumab in patients with myeloid relapse after matched-HCT. Participants will be evaluated for dose limiting toxicities (DLTs) at day 43. DLTs explained within section 5.4 of the protocol.

Groups in this outcome

CD25/Treg-depleted DLI

CD25hi Treg depleted DLI: Donor lymphocyte product -Patients will receive a defined dose of CD25hi Treg depleted DLI intravenously Ipilimumab: Ipilimumab is an antibody that acts against CTLA-4 -Ipilimumab is administered intravenously every 12 weeks

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

Analysis denominator · Participants

GroupSource count
CD25/Treg-depleted DLI25

Reported measurements

Source class 1
Values in cells/kg · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
CD25/Treg-depleted DLI30000000Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        30000000
denoms
  1. counts
    1. group Id
      OG000
      value
      25
    units
    Participants
description
The primary objective of this study is to determine the safety (MTD) of CD25/Treg-depleted donor lymphocyte infusion (DLI) plus Ipilimumab in patients with myeloid relapse after matched-HCT. Participants will be evaluated for dose limiting toxicities (DLTs) at day 43. DLTs explained within section 5.4 of the protocol.
groups
  1. description
    CD25hi Treg depleted DLI: Donor lymphocyte product -Patients will receive a defined dose of CD25hi Treg depleted DLI intravenously Ipilimumab: Ipilimumab is an antibody that acts against CTLA-4 -Ipilimumab is administered intravenously every 12 weeks
    id
    OG000
    title
    CD25/Treg-depleted DLI
param Type
NUMBER
reporting Status
POSTED
time Frame
Day 43 (6 weeks)
title
Maximum Tolerated Dose (MTD) for DLI
type
PRIMARY
unit Of Measure
cells/kg

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

Preserved source evidence · Not medical advice