Study of BST-236 and Venetoclax in patients with acute myeloid leukemia unfit for intensive induction Chemotherapy

The research company BioSight Ltd is conducting the clinical trial A Phase I/II Dose Escalation and Expansion Study of BST-236 Plus Venetoclax in Patients With Unfit Newly Diagnosed AML.

An open label multi centre study to assess the safety and efficacy of BST-236 in combination with venetoclax in adult patients unfit for standard therapy with newly diagnosed Acute Myeloid Leukemia (AML) Part 1 of the study will define the maximal tolerate dose of the combination treatment, while part 2 will expend the chosen dose, to assesses efficacy and safety of this combination.

All patients will receive 2 induction courses with both BST-236 and venetoclax, responding patients will then be followed with up to 3 maintenance courses with BST-236 alone. Patients will be followed for 1 year in the study and additional 1 year in post study follow-up

It is planned to include 80 participants.

Actual study start date is August 17, 2022. The researchers expect to complete the study by December 1, 2025.

One primary outcome measure is Dose limiting toxicity and maximal tolerated dose for part 2.

Further details can be found here https://ichgcp.net/clinical-trials-registry/NCT05503355.