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RECRUITING
NCT06477549
PHASE2

BeFluBu vs FluBuRux Conditioning in Haploidentical HCT

Sponsor: St. Petersburg State Pavlov Medical University

View on ClinicalTrials.gov

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

Interventions

DRUG

Bendamustine Hydrochloride

Days -7 through -6: Bendamustine 90 mg/m2 iv x 2 days

DRUG

Ruxolitinib

Days -7 through -2: ruxolitinib 5 mg tid per os

Locations (1)

RM Gorbacheva Research Institute

Saint Petersburg, Russia