Phase II Study of Cobicistat-Boosted Venetoclax with Azacitidine in Adults 18 and Older with Newly Diagnosed Acute Myeloid Leukemia Not Suitable for Intensive Chemotherapy

What this Trial Is About

Researchers are studying a treatment approach for older adults with acute myeloid leukemia AML who are not suitable for intensive chemotherapy. The study focuses on combining the drug venetoclax with azacitidine, and investigates whether adding cobicistat, a drug that increases venetoclax exposure, can allow for lower venetoclax doses to reduce treatment costs. This is a Phase II trial led by Stichting Hemato-Oncologie voor Volwassenen Nederland, addressing the challenge of treating older, unfit AML patients with fewer side effects and financial burden. Participants receive azacitidine and venetoclax from the first treatment cycle until relapse. Cobicistat is introduced during the run-in phase starting from cycle 2 and during the extension phase starting from cycle 1, aiming to boost venetoclax levels. The study includes a run-in phase with 20 patients and an extension phase, both following this treatment scheme. The trial is single-arm and non-randomized, designed to evaluate pharmacokinetic equivalence and overall survival among other outcomes. Throughout the study, participants will undergo regular monitoring to assess drug levels, treatment response, safety, and side effects for up to 48 months. Researchers will measure remission rates, survival rates, genetic changes, adverse events, and medication adherence. Data on cost savings and treatment effects will also be collected. Patients will be assessed for kidney and liver function, and their progress will be carefully followed to understand the impact of the cobicistat-boosted venetoclax treatment combined with azacitidine.

A Trial to Assess Cobicistat Boosted Venetoclax in Combination With Azacitidine in Adult Patients With Newly Diagnosed AML