Clinical Trial: A Study Evaluating Venetoclax in Subjects With Chronic Lymphocytic Leukemia Whose Cancer Has Come Back or Who Had No Response to Previous Cancer Treatments Including Subjects Missing Part of Their Chromosome 17, or TP53 Gene Mutation; or Who Received Prior Treatment With a B-Cell Receptor Inhibitor

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional




Official Title: Open-Label, Single Arm, Phase 3b, Multi-Center Study Evaluating the Impact of Venetoclax on the Quality of Life of Relapsed/Refractory Subjects With Chronic Lymphocytic Leukemia (CLL) Including Those

Brief Summary: The purpose of this open-label, single-arm study is to evaluate the impact of venetoclax on the quality of life of participants with chronic lymphocytic leukemia (CLL; a type of cancer affecting the blood and the bone marrow) including those with the 17p deletion or TP53 mutation (local lab assessed) OR in CLL participants who have received prior B-Cell Receptor Inhibitor (BCRi) therapy. The starting dose of venetoclax is 20 mg once daily. The dose must be gradually increased over a period of 5 weeks up to the daily dose of 400 mg. Participants may continue receiving venetoclax for up to 2 years. After the treatment period, participants may continue on into a 2-year follow-up period.