MD Anderson trial of azacitidine plus venetoclax maintenance in AML stopped for low enrollment
The phase II study, sponsored by MD Anderson with NCI and Genentech as collaborators, was terminated after failing to reach enrollment targets, according to its ClinicalTrials.gov record.
A phase II trial testing azacitidine combined with venetoclax as maintenance therapy for patients with acute myeloid leukemia (AML) in remission has been marked terminated, with the reason listed as less than 75% participation.1 The trial, registered as NCT04062266, was last updated on October 16, 2026, with a primary completion and study completion date listed as October 12, 2026.
The study was led by M.D. Anderson Cancer Center, with the National Cancer Institute (NCI) and Genentech, Inc. listed as collaborators.1 It began on September 13, 2019.
The design called for patients to receive azacitidine subcutaneously or intravenously over 1 hour daily on days 1 through 5, and venetoclax orally daily on days 1 through 14, with treatment repeating every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity.1
The primary objective was to assess relapse-free survival of patients with acute myeloid leukemia treated with azacitidine combined with venetoclax as maintenance therapy after achieving remission.1 Secondary objectives included assessment of overall survival, event-free survival, duration of remission, toxicity, and minimal residual disease dynamics.
Enrollment reached 36 participants (actual)1, according to the design section of the registry listing. The trial was conducted at a single site, M D Anderson Cancer Center in Houston, Texas, United States.1
Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.