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GvHD Prophylaxis in Unrelated Donor HCT: Randomized Trial Comparing PTCY Versus ATG

NCT05153226 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 640

Last updated 2024-12-20

No results posted yet for this study

Summary

Post-transplantation cyclophosphamide (PTCY) has become increasingly popular in the haploidentical HCT setting because it overcomes the HLA-mismatch barrier and levels GVHD risk. This advantage may also prove useful in the context of unrelated donor (UD) transplantation. GVHD prophylaxis for matched unrelated donor hematopoietic cell transplantation (alloHCT) in Europe is mainly conducted with ATG. Still, the burden of acute and chronic GVHD and especially of relapse remains high with both approaches for GVHD prevention.

PTCY has not been tested against the current standard ATG for GvHD prophylaxis in large randomized trials. The goal of this trial is to compare the outcomes of PTCY and ATG for patients receiving unrelated donor PBSCT. PTCY-based prophylaxis promises to have beneficial net effects on immune reconstitution, GVHD and disease control, and thus might impact on patient survival.

Conditions

  • Graft Vs Host Disease
  • Peripheral Blood Stem Cell Transplantation
  • AML
  • MDS
  • MDS/MPN
  • CMML

Interventions

DRUG

Cyclophosphamide

50 mg/kg (AIBW) i.v. d+3, d+4 post transplant

BIOLOGICAL

ATG

10 mg/kg i.v. d-3, d-2, d-1 pre-transplant

Sponsors & Collaborators

  • DKMS gemeinnützige GmbH

    lead OTHER

Principal Investigators

  • Johannes Schetelig, Prof Dr med · Universitätsklinikum Dresden

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-02
Primary Completion
2025-06-30
Completion
2026-12-31

Countries

  • Germany

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05153226 on ClinicalTrials.gov