🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Contributor sign in
Latest
Clinical Trials in Germany / NCT05153226
Active, not recruiting Phase 3

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

NCT05153226 · tracked via the Priya Life Science Germany tracker
Sponsor
DKMS gemeinnützige GmbH
Phase
Phase 3
Started
2022-03-02
Last updated
2026-08-27

Condition(s) studied

Graft Vs Host DiseasePeripheral Blood Stem Cell TransplantationAMLMDSMDS/MPNCMML

Investigational drug(s) / intervention(s)

Cyclophosphamide →ATG

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

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

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Signed written Informed Consent and able to understand the nature of the trial and the trial related procedures and to comply with them. * Age ≥ 18 years. * One of the following eligible diagnoses: AML in CR1 with intermediate or adverse risk genetic abnormalities (according to the ELN 2017 guidelines), or undefined risk. AML of any ELN risk category after hematological or molecular relapse, or with primary refractory disease. AML arising from myelodysplastic syndrome (MDS) or a myeloproliferative neoplasia, except if favourable genetic abnormalities (according to ELN 2017 guidelines) are present. Therapy-related myeloid neoplasia (t-MN), except if favourable genetic abnormalities (according to ELN 2017 guidelines) are present. MDS with intermediate risk, high risk or very high risk disease (according to the IPSS-R Score) regardless of treatment status. MDS/MPN and CMML-1/CMML-2 regardless of treatment status. * The left ventricular ejection fraction (LVEF) was assessed ≥40% at last echocardiography. * Transplantation with Peripheral Blood Stem Cells (PBSC) scheduled to be performed 4 to 14 days after date of randomization. * The scheduled donor is unrelated to the patient, and matched or partially matched (with not more than one allele or antigen mismatch) at HLA-A, -B, -C, or -DRB1. * Absence of pregnancy confirmed by highly sensitive pregnancy test for WOCBP. Test must not date back more than 3 days prior to randomization, or more than 3 days prior to start of conditioning, if it started before randomization. Exclusion Criteria: * Anamnestic intravenous or subcutaneous exposure to rabbit immunoglobin-preparations (e.g. Grafalon or Thymoglobulin) * Known hypersensitivity to ATG-Grafalon or its excipients. * Known hypersensitivity to cyclophosphamide, its metabolites or excipients. * Prior allogeneic hematopoietic transplantation. * Patients who receive supplementary continuous oxygen at the time of randomization. * Symptomatic heart failure (NYHA ≥2) at the time of randomization. * Uncontrolled viral, bacterial or fungal infection with progression or no clinical improvement at the time of randomization. * Symptomatic cystitis or known obstruction of urine flow at the time of randomization. * Breast-feeding women. * WOCBP and fertile male patients unable or unwilling to follow highly effective contraception methods from enrollment to minimum six months after the last dose of the IMP. * Simultaneous participation in another interventional clinical trial with an investigational medicinal product.

Primary outcome measure(s)

Trial sites (23)

FacilityCityRegionStatus
Uniklinik RWTH Aachen Aachen Germany
Univeristätsklinikum Augsburg Augsburg Germany
Klinikum Chemnitz gGmbH Chemnitz Germany
Universitätsklinikum Köln Cologne Germany
St.-Johannes-Hospital Dortmund Dortmund Germany
Universitätsklinikum Dresden Dresden Germany
Uniklinikum Düsseldorf Düsseldorf Germany
Universitätsklinikum Essen (AöR) Essen Germany
Universitätsklinikum Frankfurt Frankfurt am Main Germany
Universitätsklinikum Halle (Saale) Halle Germany
Universitätsklinikum des Saarlandes Homburg Germany
Universitätsklinikum Jena Jena Germany
Universitätsklinikum Schleswig-Holstein Kiel Germany
Universitätsklinikum Schleswig-Holstein Lübeck Germany
Universitätsmedizin Mainz Mainz Germany
Universitätsmedizin Mannheim Mannheim Germany
Philipps Universität Marburg Marburg Germany
Universitätsklinikum Münster Münster Germany
Klinikum Nürnberg Nord Nuremberg Germany
Universitätsmedizin Rostock Rostock Germany
Robert-Bosch-Krankenhaus Stuttgart Germany
Universitätsklinikum Tübingen Tübingen Germany
Universitätsklinikum Würzburg Würzburg Germany

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05153226 on ClinicalTrials.gov ↗ ← All trials in Germany