Clinical Trial

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

Active, Not Recruiting Phase 2
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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%.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2020-01-14; most recent amendment 2025-04-16.
Status change: Recruiting → Active, Not Recruiting 2025-04-16
Trial Details
NCT Number NCT04232241
Lead Sponsor Universitätsklinikum Hamburg-Eppendorf
Collaborators: Gesellschaft für Therapieforschung mbH, Staburo GmbH
Conditions Acute Myeloid Leukemia in Remission, Acute Lymphoblastic Leukemia in Remission, Myelodysplastic Syndromes
Enrollment 167 participants
Start Date 2019-11-14
Primary Completion 2026-11-22 (estimated)
Study Completion 2026-11-26 (estimated)
Updated on ClinicalTrials.gov 2025-04-22