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NCT03849651 · OUTCOME

Maximum Effective Dose for Prophylactic CD45RA-depleted DLI

TCRαβ-depleted Progenitor Cell Graft With Additional Memory T-cell DLI, Plus Selected Use of Blinatumomab, in Naive T-cell Depleted Haploidentical Donor Hematopoietc Cell Transplantation for Hematologic Malignancies · Source last updated 2026-07-22

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
4 weeks post-DLI (up to approximately 12 weeks post-transplant)

What was measured

The maximum effective dose (MED) of CD45RA-depleted DLI, defined as the maximum value of doses that satisfy the proportion of patients with their memory T cell count measured at week 4 post-DLI more than 300/uL is more than 50% and the toxicity of grade 3-4 aGVHD is less than 20%. Dose selection used a protocol-specified algorithm.

Analysis population: Patients who met eligibility criteria and received transplant during the dose-finding phase.

Groups in this outcome

Dose Finding Transplant Participants

Patients who met eligibility criteria and received transplant during the dose-finding phase.

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 Finding Transplant Participants29

Reported measurements

Source class 1
Values in cells/kg · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Finding Transplant Participants100000000Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        100000000
denoms
  1. counts
    1. group Id
      OG000
      value
      29
    units
    Participants
description
The maximum effective dose (MED) of CD45RA-depleted DLI, defined as the maximum value of doses that satisfy the proportion of patients with their memory T cell count measured at week 4 post-DLI more than 300/uL is more than 50% and the toxicity of grade 3-4 aGVHD is less than 20%. Dose selection used a protocol-specified algorithm.
groups
  1. description
    Patients who met eligibility criteria and received transplant during the dose-finding phase.
    id
    OG000
    title
    Dose Finding Transplant Participants
param Type
NUMBER
population Description
Patients who met eligibility criteria and received transplant during the dose-finding phase.
reporting Status
POSTED
time Frame
4 weeks post-DLI (up to approximately 12 weeks post-transplant)
title
Maximum Effective Dose for Prophylactic CD45RA-depleted DLI
type
PRIMARY
unit Of Measure
cells/kg

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

Preserved source evidence · Not medical advice