Evaluating Selinexor with Azacitidine and Venetoclax for Adults with Untreated Acute Myeloid Leukemia Not Eligible for Intensive Chemotherapy

What this Trial Is About

This research aims to evaluate the safety and effectiveness of combining selinexor with azacitidine and venetoclax in adults newly diagnosed with acute myeloid leukemia AML who have not received prior treatment. The study is a prospective, single-arm, multi-center clinical trial focusing on patients who are either ineligible for or refuse intensive chemotherapy. It is designed to gather data on how well this combination works and its safety profile in this patient group. Participants will receive selinexor orally at 60 mg on days 3, 10, and 17 azacitidine intravenously at 75 mgm2 on days 1-3, 8-9, and 15-16 and venetoclax orally starting at 100 mg on day 1, increasing to 200 mg on day 2, and 400 mg on days 3-14 within each 28-day treatment cycle. Those who achieve complete remission may undergo a transplant at any time, while others will continue treatment until the disease progresses or unacceptable side effects occur. During the study, participants will be closely monitored for treatment response and safety through assessments including remission rates up to about two years. Secondary measures include overall survival, response rates, minimal residual disease negativity, and recurrence-free survival over approximately four years. The total participation time varies based on individual outcomes, with ongoing evaluations to track effectiveness and side effects throughout the study period.

A Study of Selinexor in Combination With Azacitidine and Venetoclax (SAV Regimen) in Treatment Naïve Participants With Acute Myeloid Leukemia