BeFluBu vs FluBuRux Conditioning in Haploidentical HCT
Randomized Trial of Benadamustine Versus Ruxolitinib With Fludarabine and Busulfan Conditioning in Recipients of Haploidentical Stem Cell Transplantation
St. Petersburg State Pavlov Medical University
220 participants
Jun 21, 2024
INTERVENTIONAL
Conditions
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).
Eligibility
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Interventions
Days -7 through -6: Bendamustine 90 mg/m2 iv x 2 days
Days -7 through -2: ruxolitinib 5 mg tid per os
Locations(1)
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NCT06477549