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ACTIVE NOT RECRUITING
NCT04232241
PHASE2

Matched Unrelated vs. Haploidentical Donor for Allogeneic Stem Cell Transplantation in Patients With Acute Leukemia

Sponsor: Universitätsklinikum Hamburg-Eppendorf

View on ClinicalTrials.gov

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%.

Official title: Matched Unrelated vs. Haploidentical Donor for Allogeneic Stem Cell Transplantation in Patients With Acute Leukemia With Identical GVHD Prophylaxis - A Randomized Prospective European Trial.

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

167

Start Date

2019-11-14

Completion Date

2026-11-26

Last Updated

2025-04-22

Healthy Volunteers

No

Interventions

DRUG

Allogeneic Stem Cell Transplantation

Allogeneic Stem Cell Transplantation

Locations (24)

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