Acute myeloid leukemia (AML) is an aggressive and rare cancer of myeloid cells (white blood cells responsible for fighting infection). The successful treatment of AML depends on which subtype of AML the patient has and how old the patient is at diagnosis. Venetoclax is a drug that kills cancer cells by blocking a protein (part of a cell) that allows cancer cells to stay alive. The aim of the study is to investigate the safety and efficacy of venetoclax and azacitidine compared to Best Supportive Care (BSC) in patients with AML after allogeneic stem cell transplantation.
Aim of the study
The study examines patients with AML after allogeneic stem cell transplantation. We are conducting this study to evaluate the safety and efficacy of venetoclax in combination with azacitidine
Who can take part?
Patients with AML according to the criteria of the World Health Organization (WHO). In addition, an allogeneic stem cell transplant must either be planned or have been performed within the last 14 days.
Procedure
The study has two parts: In part 1, the best dose of venetoclax and/or azacitidine was determined. Part 1 is now closed to new patients. In part 2, the effect of venetoclax/azacitidine together with supportive therapy is compared with supportive therapy alone. The study comprises a 14-day screening phase followed by treatment for 24 cycles with venetoclax in combination with azacitidine (6 cycles) or supportive therapy.
Compensation
None
Original study name
A randomized, open-label phase 3 study to evaluate the safety and efficacy of venetoclax in combination with azacitidine after allogeneic stem cell transplantation in patients with acute myeloid leukemia (AML)
BASEC number
2019-02129
Financial support from
AbbVie