NCT06477549

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 220 (estimated)
• Sponsor: St. Petersburg State Pavlov Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Acute Lymphoblastic Leukemia
• Acute Myeloid Leukemia
• Biphenotypic Acute Leukemia
• Lymphoblastic Lymphoma
• Myeloproliferative Neoplasm
• Myelodysplastic Syndromes

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-06-21
• Primary completion: 2028-06-01
• Completion: 2029-06-01
• First posted: 2024-06-27
• Last updated: 2024-06-27

Locations

1 site across 1 country: Russia