drugset / Trial / NCT01496547
Sequential Intensive Chemotherapy Followed by RIC for Refractory and Relapse AML
NaSingle-groupOpen-labelTreatment
Summary
Patients with refractory and relapse leukemia had poor outcome even with allogeneic stem cell transplantation. In our previous retrospective study, the overall survival is 14.6+/-8.8% while 90% patients eventually relapsed with marrow ablative conditioning mostly standard iv-Bu-Cy or Cy-TBI. The accumulated TRM is 29.5+/-11.5%. Thus our data suggested that the conventional transplantation approach may not be able to overcome the refractory disease. A new strategy to combined a low dose regimen following intensive chemotherapy for tumor reduction seems to be effect in both relapsed. high-risk and refractory AML or ALL. In this study, we focus on a new treatment strategy for particular refractory AML patients.
Timeline
- Start
- 2011-01
- Primary completion
- 2018-02-28
- Completion
- 2018-06-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Busulfan | Small molecule | 3.2 mg/kg | Intravenous |
| Subject | Cytarabine | Small molecule | 2000 mg/m2 | — |
| Subject | Fludarabine | Small molecule | 35 mg/m2 | — |
| Subject | Idarubicin | Small molecule | 12 mg/m2 | — |