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BeFluBu vs FluBuRux Conditioning in Haploidentical HCT
Sponsor: St. Petersburg State Pavlov Medical University
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).
Official title: Randomized Trial of Benadamustine Versus Ruxolitinib With Fludarabine and Busulfan Conditioning in Recipients of Haploidentical Stem Cell Transplantation
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
220
Start Date
2024-06-21
Completion Date
2029-06
Last Updated
2024-06-27
Healthy Volunteers
No
Conditions
Interventions
Bendamustine Hydrochloride
Days -7 through -6: Bendamustine 90 mg/m2 iv x 2 days
Ruxolitinib
Days -7 through -2: ruxolitinib 5 mg tid per os
Locations (1)
RM Gorbacheva Research Institute
Saint Petersburg, Russia