drugset / Trial / NCT03435848
Efficacy and Safety of BST-236 in Newly Diagnosed Acute Myeloid Leukemia Patients, Unfit for Standard Induction Therapy
NaSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to assesses the benefit, safety, and pharmacokinetics (PK) of BST-236 in patients with newly-diagnosed Acute Myeloid Leukemia (AML) who are not eligible for standard induction chemotherapy due to advanced age or comorbidities. The Complete Remission (CR) rate following treatment with BST-236 will be compared to the CR rate reported in historical data in a similar population.
Timeline
- Start
- 2018-08-14
- Primary completion
- 2023-03-16
- Completion
- 2023-03-16
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | aspacytarabine | Small molecule | 2500 mg/m2 | Intravenous |
| Subject | aspacytarabine | Small molecule | 4500 mg/m2 | Intravenous |