drugset / Trial / NCT02671708
IDA+BUCY vs BUCY Conditioning Regimen for Intermediate-risk AML Undergoing Auto-HSCT
Phase 2/3
Completed
153 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
Autologous hematopoietic stem cell transplantation (Auto-HSCT) is an effective alternative to allogeneic HSCT for intermediate-risk acute myeloid leukemia (AML) without HLA-matched donors. At present, the best conditioning regimen for AML undergoing auto-HSCT remains in discussion. In this study, the safety and efficacy of IDA+BUCY and BUCY myeloablative conditioning regimens in intermediate-risk AML undergoing auto-HSCT are evaluated.
Timeline
- Start
- 2016-01
- Primary completion
- 2019-02-28
- Completion
- 2020-02-28
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Busulfan | Small molecule | 3.2 mg/kg | — |
| Subject | Cyclophosphamide | Other / unclassified | 60 mg/kg | — |
| Subject | Idarubicin | Small molecule | 15 mg/m2 | — |