drugset / Trial / NCT03596892
Decitabine+BUCY vs BUCY Conditioning Regimen for MLL+ Acute Leukemia Undergoing Allo-HSCT
Phase 2/3
Unknown
122 enrolled
Nanfang Hospital, Southern Medical University
Guangzhou First People's Hospital · collabPeking University People's Hospital · collabSun Yat-Sen Memorial Hospital of Sun Yat-Sen University · collabThird Affiliated Hospital, Sun Yat-Sen University · collabZhujiang Hospital · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
Recent studies demonstrated that allogeneic hematopoietic stem cell transplantation (allo-HSCT) could be a valuable treatment choice for mixed-lineage-leukemia (MLL)-rearranged acute leukemia. Unfortunately, some patients relapsed after allo-HSCT. In this prospective randomized controlled study, the safety and efficacy of Decitabine + BUCY and BUCY myeloablative conditioning regimens in MLL+ acute leukemia undergoing allo-HSCT are evaluated.
Timeline
- Start
- 2018-07
- Primary completion
- 2021-06
- Completion
- 2022-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Decitabine | Small molecule | 20 mg/m2 | — |
| Background | Busulfan | Small molecule | 3.2 mg/kg | — |
| Background | Cyclophosphamide | Other / unclassified | 60 mg/kg | — |