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BST-236 Plus Venetoclax in Newly Diagnosed Unfit AML
NCT05503355Phase 2
Key facts
- Status
- Recruiting
- Start
- Aug 2022
- Primary completion
- Aug 2025
- Countries
- 1
- Sponsor
- BioSight
- Modality
- Small Molecules
- Drugs
- aspacytarabine
- Conditions
- acute myeloid leukemia (AML)
01
Overview
Phase 2, open-label, single-arm trial of aspacytarabine in acute myeloid leukemia (AML), sponsored by BioSight. Primary endpoints: Dose limiting toxicity at Day 42, Maximal Tolerated Dose at Day 42 and 1 more. Started Aug 2022; status: recruiting.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
BST-236 + Venetoclax
Experimental arm receiving BST-236 and Venetoclax induction followed by BST-236 maintenance.
03
Who it enrols
Adults with newly diagnosed AML (de-novo or secondary) who are unfit for standard induction chemotherapy, have not received prior AML treatment or specific prior MDS treatments (cytarabine, HMAs, venetoclax), and have adequate organ function.
04
Endpoints
Primary
Dose limiting toxicity
Maximal Tolerated Dose
Efficacy Assessment in Part 2
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