RecruitingPhase 2NCT06477549

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


Sponsor

St. Petersburg State Pavlov Medical University

Enrollment

220 participants

Start Date

Jun 21, 2024

Study Type

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study compares two preparatory regimens used before a bone marrow (stem cell) transplant from a partially-matched family donor. Both regimens use strong chemotherapy to wipe out the diseased bone marrow before the donor cells are infused. The goal is to find out which approach has better outcomes. **You may be eligible if...** - You have a blood cancer (such as leukemia or myelodysplastic syndrome) that requires a stem cell transplant - Your disease is in remission (less than 5% cancer cells in bone marrow) - You have a half-matched (haploidentical) family donor available - You are 18 or older **You may NOT be eligible if...** - You have significant organ problems (heart, liver, kidney, or lung) - You have uncontrolled infection - The donor has antibodies that would attack your cells Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBendamustine Hydrochloride

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

DRUGRuxolitinib

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


Locations(1)

RM Gorbacheva Research Institute

Saint Petersburg, Russia

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NCT06477549


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