Phase 2 Study of Adaptive Treatment for Acute Myeloid Leukemia Using Selinexor, Azacitidine, and Venetoclax Based on Day 14 MRD Results

What this Trial Is About

Researchers are studying an adaptive treatment approach for adults with newly diagnosed acute myeloid leukemia AML who are not suitable for intensive chemotherapy. This phase 2, prospective, single-arm, multi-center clinical trial evaluates the safety and effectiveness of combining selinexor with azacitidine and venetoclax based on measurable residual disease MRD results taken on day 14 of the first treatment cycle. Participants receive azacitidine at 75 mgm2 on days 1 through 7 and venetoclax starting at 100 mg on day 1, increasing to 200 mg on day 2 and 400 mg daily from days 3 to 28, in 28-day cycles. On cycle 1 day 14, MRD is assessed patients who test negative continue azacitidine and venetoclax alone, while those who test positive add selinexor 60 mg on days 15 and 22. Patients may receive transplants once complete remission is achieved or continue treatment until disease progression or unacceptable side effects occur. During the study, participants undergo regular evaluations including MRD testing, survival assessments, and response monitoring for up to approximately four years. The primary outcome is the percentage of participants achieving composite complete remission within about two years. The study also monitors overall survival, overall response rate, MRD negativity rates, and recurrence-free survival. Treatment safety and tolerability are closely observed throughout the trial period.

Adaptive Treatment for Acute Myeloid Leukemia Based on D14 MRD Results