A Study to Assess the Effect of Venetoclax on the Pharmacokinetics of Ethinyl Estradiol/Levonorgestrel in Female Subjects With Hematologic Malignancies

What this Trial Is About

Researchers are studying the effects of multiple doses of venetoclax on how the body processes ethinyl estradiol and levonorgestrel in female participants who have various types of blood cancers, specifically different subtypes of non-Hodgkin's lymphoma. This Phase 1 trial aims to understand the pharmacokinetics of these drugs when given together to help guide treatment decisions. Participants receiving clinical benefit without disease progression may continue venetoclax treatment in a separate extension study. The study involves administering ethinyl estradiol/levonorgestrel tablets on the first day of the first and third periods, while venetoclax tablets are given starting on the first day of the second period and then daily thereafter. This design allows researchers to evaluate the interaction between the drugs over approximately 59 days after the initial dose. The trial does not include masking or placebo controls. During the study, participants undergo monitoring to measure key drug parameters such as the time to reach maximum concentration (Tmax), maximum concentration (Cmax), half-life (t1/2), and overall drug exposure (AUC) for both venetoclax and ethinyl estradiol/levonorgestrel. These assessments help understand how the drugs behave in the body. Safety and disease status are also monitored, and participants may continue treatment in an extension phase if benefiting from the therapy. The total study duration includes follow-up up to about 59 days after the initial dose.

A Study to Assess the Effect of Venetoclax on Ethinyl Estradiol and Levonorgestrel in Female Participants With Different Hematological Malignancies