Decitabine Plus mBU/CY Preconditioning for Relapse/Refractory Acute Leukemia
Summary
Allogeneic haematopoietic stem cell transplantation (allo-HSCT) remains one of the currently available curative therapies for acute leukemia (AL). Leukemia relapse is one of the mainly causes of transplant failure. We reported previously that patients with relapse or refractory AL were at very high risk of relapse post allo-HSCT, with cumulative relapse rate of 50-80%. Decitabine has been demonstrated efficacy in the treatment of patients with recurrent or refractory leukemia and myelodysplastic syndrome. It was reported that the combination of decitabine, with busulfan and cyclophosphamide as a preparative regimen for allo-HSCT using HLA-matching donors was safe and effective. In this prospective, single-arm clinical trial, we aimed to examine the efficacy of combining decitabine with modified busulfan and cyclophosphamide (mBU/CY) as a preparative regimen for allo-HSCT in recurrent and refractory AL patients.
Timeline
- Start
- 2018-12-01
- Primary completion
- 2021-12-31
- Completion
- 2023-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Decitabine | Small molecule | 200 mg/m2 | Intravenous |
| Background | Busulfan | Small molecule | 3.2 mg/kg | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | 1.8 g | Intravenous |
| Background | Cytarabine | Small molecule | 2 g | Intravenous |
| Background | Cytarabine | Small molecule | 4 g | Intravenous |
| Background | Hydroxyurea | Other / unclassified | 80 mg/kg | Oral |
| Background | Semustine | Small molecule | 250 mg/m2 | Oral |
| Background | Thymoglobulin | Protein / enzyme biologic | 2.5 mg/kg | Intravenous |