Trials / Completed

CompletedNCT04942730

Benadamustine, Fludarabine and Busulfan Conditioning in Recipients of Haploidentical Stem Cell Transplantation (FluBuBe)

Status: Completed
Phase: Phase 2
Study type: Interventional
Enrollment: 50 (actual)

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 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 10-20% of graft failures. Fludarabine and busulfan conditioning is the most commonly used approach for a variety of disease. Furthermore combination of fludarabine and bendamustine was sufficient to facilitate engraftment in patients with chronic lymphocytic leukemia and lymphomas. The aim of the study is to evaluate whether addition of bendamustine to fladarabine and busulfan conditioning reduces the risk of primary graft failure after haploidentical allograft.

Conditions

Interventions

Type	Name	Description
DRUG	Fludarabine	30 mg/m2/day iv x 6 days, days -7 through -2 of HSCT
DRUG	Bendamustine Hydrochloride	130 mg/m2 iv x 2 days, Days -7 through -6 of HSCT
DRUG	Busulfan	1 mg/kg po qid x 3 days, Days -5 through -3
DRUG	Cyclophosphamide	50 mg/kg iv x 2 days, Days +3 through +4
DRUG	Mycophenolate Mofetil	45 mg/kg/day, maximum 3 g/day, iv or po x 30 days, Days +5 through +35
DRUG	Tacrolimus 5Mg Cap	0.03 mg/kg/day iv or po, Days +5 through +100 with with further correction by concentration. Target concentration 5-15 ng/ml.

Timeline

Start date: 2021-01-21
Primary completion: 2024-04-30
Completion: 2024-04-30
First posted: 2021-06-28
Last updated: 2024-05-07

Locations

1 site across 1 country: Russia

Source: ClinicalTrials.gov record NCT04942730. Inclusion in this directory is not an endorsement.