drugset / Trial / NCT03256071
Low Dose Decitabine + Modified BUCY Conditioning Regimen for High Risk Acute Myeloid Leukemia Undergoing Allo-HSCT
Phase 2/3
Unknown
90 enrolled
The First Affiliated Hospital of Soochow University
Jiangsu University · collabSoutheast University, China · collabThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · collabXuzhou Medical University · collab
RandomizedParallel-groupDouble-blindTreatment
Summary
The purpose of this prospective, open-label, randomized multicenter study is to evaluate the safety and efficacy of low dose decitabine in combination with modified BUCY vs modified BUCY as a myeloablative conditioning regimen for high-risk patients with acute myeloid leukemia (AML) undergoing allogeneic hematopoietic stem cell transplantation (Allo-HSCT).
Timeline
- Start
- 2017-09
- Primary completion
- 2020-09
- Completion
- 2021-09
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 | 1.8 g | — |
| Background | Cytarabine | Small molecule | 2 g | — |
| Background | Cytarabine | Small molecule | 4 g | — |
| Background | Semustine | Small molecule | 250 mg/m2 | — |