Phase II trial of venetoclax in combination with azacitidine as maintenance therapy for acute lymphoblastic leukemia following allogeneic stem cell transplantation
Phase II trial showed venetoclax and azacitidine maintenance improves relapse-free survival in acute lymphoblastic leukemia, indicating a well-tolerated treatment option.
Key Points
To evaluate the safety and efficacy of venetoclax in combination with azacitidine as maintenance therapy following allogeneic stem cell transplantation in acute lymphoblastic leukemia patients.
Phase II trial with high-risk acute lymphoblastic leukemia patients post-allogeneic stem cell transplantation.
Participants were in complete remission without detectable measurable residual disease at enrollment.
Treatment involved up to 12 cycles of venetoclax and azacitidine.
Primary endpoints included relapse-free survival and safety.
77.8% relapse-free survival at 1 year and 2 years after treatment initiation.
Overall survival was 85.7% at 1 year and 2 years.
Common grade 3–4 adverse events included anemia and neutropenia, with no treatment-related infections.