drugset / Trial / NCT03435848

Efficacy and Safety of BST-236 in Newly Diagnosed Acute Myeloid Leukemia Patients, Unfit for Standard Induction Therapy

NCT03435848 ↗

Phase 2 Completed 66 enrolled BioSight Ltd.
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

EvaluationDrugModalityDoseRoute
Subject aspacytarabine Small molecule 2500 mg/m2 Intravenous
Subject aspacytarabine Small molecule 4500 mg/m2 Intravenous