Study of Avapritinib with Azacitidine and Venetoclax for Relapsed Acute Myeloid Leukemia After Stem Cell Transplant

What this Trial Is About

Researchers are evaluating the safety and effectiveness of avapritinib combined with azacitidine and venetoclax in treating patients with recurrent acute myeloid leukemia AML who have specific genetic mutations C-KIT mutation with RUNX1RUNX1T1 or CBFBMYH11 after undergoing allogeneic hematopoietic stem cell transplantation. This is a single-center, prospective, single-arm exploratory clinical study focused on this patient group. The treatment is divided into two periods induction and consolidation. During induction, patients receive 1-2 cycles of avapritinib 100 mg daily for 14 days, azacitidine 35 mgm2 intravenously for 5 days, and venetoclax 100 mg daily for 14 days in a 28-day cycle, followed by evaluation of treatment response. Patients who achieve complete remission proceed to consolidation therapy, which involves avapritinib monotherapy 100 mg daily for four 28-day cycles. Participants will undergo evaluations after each induction cycle to assess treatment response, including measuring overall response rate at 2 months. Further assessments after consolidation therapy and safety monitoring for up to 2 years are included. The study involves clinical exams, laboratory tests, and monitoring of organ function to understand the treatment effects and safety over time. Total participation duration covers induction, consolidation, and safety follow-up periods.

Avapritinib Combined With Azacitidine and Venetoclax in the Treatment of Relapsed AML After Allo-HSCT