drugset / Trial / NCT04942730
Benadamustine, Fludarabine and Busulfan Conditioning in Recipients of Haploidentical Stem Cell Transplantation (FluBuBe)
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2021-01-21
- Primary completion
- 2024-04-30
- Completion
- 2024-04-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bendamustine | Small molecule | 130 mg/m2 | Intravenous |
| Background | Busulfan | Small molecule | 1 mg/kg | Oral |
| Background | Cyclophosphamide | Other / unclassified | 50 mg/kg | Intravenous |
| Background | Fludarabine | Small molecule | 30 mg/m2 | Intravenous |
| Background | Mycophenolate Mofetil | Small molecule | 45 mg/kg | Intravenous |
| Background | Tacrolimus | Small molecule | 0.03 mg/kg | Intravenous |