Phase 3 Study of Azacitidine and Venetoclax as Maintenance Therapy for Younger Adults With Favorable-Risk Acute Myeloid Leukemia in First Remission After Chemotherapy

What this Trial Is About

Researchers are evaluating whether azacitidine combined with venetoclax as maintenance therapy can improve relapse-free survival for younger adults aged 18 to 64 with favorable-risk acute myeloid leukemia AML who have remained in their first complete remission after intensive consolidation chemotherapy. This phase III trial aims to compare the effects of this combination therapy against observation and supportive care during remission. The study is sponsored by The First Affiliated Hospital of Soochow University and includes participants who have completed remission induction and consolidation therapy and are not immediate candidates for stem cell transplant. Participants in the treatment group will receive azacitidine by subcutaneous injection once daily on days 1 through 5 and venetoclax by mouth once daily on days 1 through 14 of each 28-day cycle. This will continue for a total of 8 cycles. The comparison group will receive observation and supportive care to manage any complications during remission. There is no blinding, and participants are randomly assigned to one of the two groups. During the trial, researchers will monitor relapse-free survival from the date of complete remission to relapse or death for up to about three years. They will also assess secondary outcomes such as minimal residual disease negative conversion, duration of complete remission, overall survival, event-free survival, and the occurrence of adverse events. Participants will undergo disease monitoring and supportive care as needed. The study is expected to continue until June 2030, with regular follow-up visits to assess health and treatment outcomes.

AZA + Venetoclax as Maintenance Therapy in Younger Adults With AML in First Remission