Matched Unrelated vs. Haploidentical Donor for Allogeneic Stem Cell Transplantation in Patients With Acute Leukemia
Condition(s) studied
Investigational drug(s) / intervention(s)
Allogeneic Stem Cell Transplantation: Allogeneic Stem Cell Transplantation
Study summary
Primary objective of this open label, two-arm, multicenter, multinational, randomized trial is to compare anti-leukemic activity of allogeneic stem cell transplantation for patients with acute leukemia in complete remission between a 10/10 HLA matched unrelated donor and a haploidentical donor.
The hypothesis: Haploidentical stem cell transplantation with post cyclophosphamide induces a stronger anti-leukemic activity in comparison to 10/10 HLA matched unrelated donor and reduces the risk of relapse at 2 years after stem cell transplantation by 10%.
Eligibility
Primary outcome measure(s)
- Relapse incidence at two years between both arms — 2 years
The primary efficacy endpoint will be analyzed using cumulative incidence estimation to assess the subdistribution hazard rates for both treatment groups at two years after accounting for competing risk events.
Trial sites (24)
| Facility | City | Region | Status |
|---|---|---|---|
| LKH-Univ. Klinikum Graz | Graz | Austria | |
| Medizinische Universität Innsbruck | Innsbruck | Austria | |
| Medizinische Universität Wien, Universitätsklinik für Innere Medizin I Einrichtung für Stammzelltransplantation KMT | Vienna | Austria | |
| Institute of Hematology and Blood Transfusion | Prague | Czechia | |
| Turku University Central Hospital | Turku | Finland | |
| University Hospital Düsseldorf | Düsseldorf | Germany | |
| Universitätsklinikum Essen | Essen | Germany | |
| Universitätsklinikum Frankfurt am Main | Medizinische Klinik II | Frankfurt | Germany | |
| Universitätsklinikum Freiburg | Freiburg im Breisgau | Germany | |
| Universitätsklinikum Hamburg-Eppendorf | Hamburg | Germany | |
| Medizinische Hochschule Hannover | Hanover | Germany | |
| Universitätsklinikum Leipzig Dep. Innere Medizin, Neurologie und Dermatologie Medizinische Klinik und Poliklinik I - Hämatologie und Zelltherapie, Hämostaseologie | Leipzig | Germany | |
| Universitätsklinikum Münster | Münster | Germany | |
| Universitätsklinikum Tübingen | Tübingen | Germany | |
| ASST Papa Giovanni XXIII | Bergamo | Italy | |
| Pavlov First Saint Petersburg State Medical University | Saint Petersburg | Russia | |
| Hospital Universitari Germans Trias I Pujol | Badalona | Spain | |
| Hospital Clínico y Provincial de Barcelona | Barcelona | Spain | |
| Hospital de la Santa Creu I Sant Pau | Barcelona | Spain | |
| Hospital General Universitario Gregorio Marañón | Madrid | Spain | |
| Hospital Universitario de Salamanca | Salamanca | Spain | |
| Hospital Universitario Virgen del Rocío | Seville | Spain | |
| Hospital Clínico Universitario de Valencia | Valencia | Spain | |
| Hospital Universitario y Politécnico de La Fe | Valencia | Spain |
More Universitätsklinikum Hamburg-Eppendorf trials in Czechia
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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 NCT04232241 on ClinicalTrials.gov ↗ ← All trials in Czechia