drugset / Trial / NCT05477589
Studying Conditioning Regimen In Pediatric Transplantation - AML , SCRIPT-AML
RandomizedFactorialOpen-labelTreatment
Summary
It is a randomized phase 3 study comparing two conditioning regimens in children with Acute Myeloid Leukemia, AML, undergoing allogenic stem cell transplantation. The primary aim is to investigate if a conditioning regimen containing one alkylator (Bu) combined with two antimetabolites (Clo and Flu) results in superior 2-year acute grade III to IV-free, chronic non-limited GvHD-free, relapse free survival than a conditioning regimen combining three alkylating agents (BuCyMel)
Timeline
- Start
- 2022-06-07
- Primary completion
- 2029-12-31
- Completion
- 2031-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Clofarabine | Other / unclassified | — | — |
| Comparator | Cyclophosphamide | Other / unclassified | — | — |
| Subject | Fludarabine | Small molecule | — | — |
| Comparator | Melphalan | Small molecule | — | — |
| Background | Busulfan | Small molecule | — | — |