drugset / Trial / NCT03852407
Allogeneic Hematopoietic Cell Transplantation From HLA-matched Donor After Flu-Mel-PTCy Versus Flu-Mel-ATG Reduced-intensity Conditioning
RandomizedParallel-groupOpen-labelTreatment
Summary
The present project aims at comparing two conditioning regimens (FM-PTCy vs FM-ATG). The hypothesis is that one or the two regimens will lead to a 2-year cGRFS rate improvement from 30% (the cGRFS rate with FM without ATG/PTCy) to 45% (Pick-a-winner phase 2 randomized study).
Timeline
- Start
- 2019-02-04
- Primary completion
- 2033-11-01
- Completion
- 2038-11-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cyclophosphamide | Other / unclassified | 50 mg/kg | — |
| Subject | Thymoglobulin | Protein / enzyme biologic | 2.5 mg/kg | — |
| Background | Fludarabine | Small molecule | 30 mg/m2 | Intravenous |
| Background | Melphalan | Small molecule | 100 mg/m2 | — |