Spots Global Cancer Trial Database for Matched Unrelated vs. Haploidentical Donor for Allogeneic Stem Cell Transplantation in Patients With Acute Leukemia
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Trial Identification
Brief Title: Matched Unrelated vs. Haploidentical Donor for Allogeneic Stem Cell Transplantation in Patients With Acute Leukemia
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.
Study ID: NCT04232241
Interventions
Study Description
Brief 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%.
Detailed Description: Secondary objectives are to assess and compare the safety and efficacy of study treatments therapy in both study arms on non-relapse mortality (NRM), relapse-free survival (RFS), Overall survival (OS), QOL, toxicity, development of acute and chronic GvDH as well as engraftment and chimerism and impact of measurable residual disease.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
LKH-Univ. Klinikum Graz, Graz, , Austria
Medizinische UniversitÀt Innsbruck, Innsbruck, , Austria
Medizinische UniversitĂ€t Wien, UniversitĂ€tsklinik fĂŒr Innere Medizin I Einrichtung fĂŒr Stammzelltransplantation KMT, Wien, , Austria
Institute of Hematology and Blood Transfusion, Prague, , Czechia
Turku University Central Hospital, Turku, , Finland
University Hospital DĂŒsseldorf, DĂŒsseldorf, , Germany
UniversitÀtsklinikum Essen, Essen, , Germany
UniversitÀtsklinikum Frankfurt am Main | Medizinische Klinik II, Frankfurt, , Germany
UniversitÀtsklinikum Freiburg, Freiburg, , Germany
UniversitÀtsklinikum Hamburg-Eppendorf, Hamburg, , Germany
Medizinische Hochschule Hannover, Hannover, , Germany
UniversitÀtsklinikum Leipzig Dep. Innere Medizin, Neurologie und Dermatologie Medizinische Klinik und Poliklinik I - HÀmatologie und Zelltherapie, HÀmostaseologie, Leipzig, , Germany
UniversitĂ€tsklinikum MĂŒnster, MĂŒnster, , Germany
UniversitĂ€tsklinikum TĂŒbingen, TĂŒbingen, , Germany
ASST Papa Giovanni XXIII, Bergamo, , Italy
Pavlov First Saint Petersburg State Medical University, St. Petersburg, , Russian Federation
Hospital Universitari Germans Trias I Pujol, Badalona, , Spain
Hospital ClĂnico 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 RocĂo, Sevilla, , Spain
Hospital ClĂnico Universitario de Valencia, Valencia, , Spain
Hospital Universitario y Politécnico de La Fe, Valencia, , Spain
Contact Details
Name: Nicolaus Kröger, Prof. Dr.
Affiliation: University Medical Center Hamburg-Eppendorf, Department of Stem Cell Transplantation
Role: PRINCIPAL_INVESTIGATOR
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