About this trial
The primary objective is to define the safety and tolerability of AB8939 in patients with AML by determining the dose-limiting toxicities, the maximum tolerated dose, and the recommended dose for dose expansion study.
Eligibility criteria
Qualifiers
Patients with documented diagnosis of acute myeloid leukemia (AML) based on the last version of the World Health Organization classification and eligible to second or third line of treatment.
Patients with documented diagnosis of refractory melyodisplastic syndrome in second or third line of treatment, and with high risk at prognosis based on the IPSS-R scoring system.
ECOG performance status ≤ 1
Patients are able to understand, sign, and date the written informed consent form at screening visit prior to any protocol-specific procedures
Disqualifiers
Patients eligible to a standard of care
Patients eligible to hematopoietic stem cell transplantation (HSCT) at the time of inclusion
Patients diagnosed with acute promyelocytic leukemia (M3)
Patients with clinically active CNS leukemia
Trial design
Treatments tested in this trial
- AB8939
- Venetoclax