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

Treatment groups

78 Participants
are divided into 2 treatment groups

Locations

10
France
Institut Paoli Calmettes Marseille France
Greece
National and Kapodistrian University of Athens NKUA · Department of Hematology and Bone marrow Transplantation Unit Athens Greece
Spain
General University Hospital of Alicantet (Hospital General Universitario Dr. Balmis de Alicante) Alicante Spain
Hospital San Pedro de Alcantara Cáceres Spain

Sponsors and collaborators

AB Science

Lead sponsor