Clinical Trial

BeFluBu vs FluBuRux Conditioning in Haploidentical HCT

Recruiting Phase 2
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Summary
Haploidentical hematopoietic stem cell transplantation irrespective of the conditioning intensity and graft-versus-host disease prophylaxis is associated with high frequency of primary and secondary graft failure. Different technologies of with replete or depleted graft are associated with 7-20% of graft failures in different diseases. Fludarabine and busulfan conditioning is the most commonly used approach for a variety of diseases. In two previously completed trials of addition of either bendamustine and ruxolitinib to conditioning we observed low rates of primary graft failure with both approaches. The study is the direct randomized comparisons of these two approaches with the primary aim of reducing composite events of primary graft failure, relapse and non-relapse mortality. The stratas for the study are Disease Risk Index (DRI) and the age of the haploidentical donor (\<35 vs ≥35).
Trial Details
NCT Number NCT06477549
Lead Sponsor St. Petersburg State Pavlov Medical University
Conditions Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Biphenotypic Acute Leukemia, Lymphoblastic Lymphoma, Myeloproliferative Neoplasm, Myelodysplastic Syndromes
Enrollment 220 participants
Start Date 2024-06-21
Primary Completion 2028-06 (estimated)
Study Completion 2029-06 (estimated)
Updated on ClinicalTrials.gov 2024-06-27