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

StatusActive, Not Recruiting
PhasePhase 2
Started
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Record History

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  1. Primary completion date: Nov 2022 to Nov 22, 2026v4 Show 5 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 440 to confirmed 167
    • Study completion date: Nov 2024 to Nov 26, 2026
    • Site details revised at 24 of 24 sites
    • Collaborators revised (2)
  2. Study sites: 22 to 24v3
  3. Study sites: 9 to 22v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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%.
Trial Details
NCT Number NCT04232241
Lead Sponsor Universitätsklinikum Hamburg-Eppendorf
Collaborators: Gesellschaft für Therapieforschung mbH, Staburo GmbH
Conditions
(from sponsor)		 Acute Myeloid Leukemia in Remission, Acute Lymphoblastic Leukemia in Remission, Myelodysplastic Syndromes
Related terms Leukemia, Myeloid, Acute, Myelodysplastic Syndromes, Precursor Cell Lymphoblastic Leukemia-Lymphoma
Enrollment 167 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov