A Study of Venetoclax in Combination With Obinutuzumab in Participants With Chronic Lymphocytic Leukemia
Status:
Completed
Trial end date:
2019-08-23
Target enrollment:
Participant gender:
Summary
This multi-center, open-label, dose-finding study will evaluate the safety and
pharmacokinetics as well as the preliminary efficacy of venetoclax (GDC-0199; ABT-199)
administered in combination with obinutuzumab to participants with relapsed/refractory or
previously untreated chronic lymphocytic leukemia (CLL). The study is comprised of two stages
for each participant population: a dose-finding stage and a safety-expansion stage. The
dose-finding stage will explore multiple doses of venetoclax to be used in combination with a
fixed dose of obinutuzumab. The dose-finding stage will also explore two schedules for drug
administration, Schedule A (venetoclax introduced before obinutuzumab) and Schedule B
(venetoclax introduced after obinutuzumab).