A Study of Venetoclax in Combination With Obinutuzumab in Participants With Chronic Lymphocytic Leukemia

• Status: Completed
• Trial end date: 2019-08-23
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Genentech, Inc.
• Collaborator: AbbVie (prior sponsor, Abbott)
• Treatments: Obinutuzumab; Venetoclax

Criteria

Inclusion Criteria:

• Diagnosis of relapsing/refractory or previously untreated chronic lymphocytic leukemia

• Eastern Cooperative Oncology Group (ECOG) performance score of less than or equal to (
• Adequate bone marrow function

• Adequate coagulation, renal and hepatic function

• For all participants, agreement to remain abstinent or use contraceptive methods that result in a failure rate of less than (<) 1% per year during the treatment period and for at least 90 days (30 days for women) after the last dose of venetoclax or 18 months after the last dose of obinutuzumab, whichever is longer

Exclusion Criteria:

• Participants who have undergone allogenic stem cell transplant are ineligible unless they meet the following criteria, a) participants who are off all immunosuppressive therapy, b) participants who have no signs and/or symptoms of acute or chronic graft versus host disease, or c) participants must have appropriate hematology counts

• Infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C

• Uncontrolled autoimmune hemolytic anemia or thrombocytopenia

• Investigational or anti-cancer therapy within 5 half-lives prior to the first dose of study drug

• History of significant renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, cardiovascular, or hepatic disease