drugset / Trial / NCT04123392
Decitabine + BUCY vs BUCY Conditioning Regimen for TP53+ Myeloid Tumors Undergoing Allo-HSCT
Phase 2/3
Unknown
196 enrolled
Nanfang Hospital, Southern Medical University
Peking 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 have demonstrated that allogeneic hematopoietic stem cell transplantation (allo-HSCT) could be a valuable treatment choice for TP53+ myeloid tumors, such as acute myeloid leukemia and myelodysplastic syndrome. 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 TP53+ myeloid tumors undergoing allo-HSCT are evaluated.
Timeline
- Start
- 2019-10
- Primary completion
- 2022-09
- Completion
- 2023-09
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 | — |