A Study of Venetoclax in Combination With Obinutuzumab in Participants With Chronic Lymphocytic Leukemia
Completed · Phase 1
Conditions studied: Lymphocytic Leukemia, Chronic
In brief
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).
Key facts
- Study ID
- NCT01685892
- Run by
- Genentech, Inc.
- People needed
- 82
- Starts
- 2012-11-29
- Expected to finish
- 2019-08-23
- Last updated by the study team
- 2020-01-10
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Diagnosis of relapsing/refractory or previously untreated chronic lymphocytic leukemia
- Eastern Cooperative Oncology Group (ECOG) performance score of less than or equal to (</=) 1
- 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
You may not qualify if…
- 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
Where it is running
- UCSD Moores Cancer Center — La Jolla, California, United States
- Colorado Blood Cancer Institute (CBCI) at Presbyterian/ St. Luke's Medical Center — Denver, Colorado, United States
- Weill Cornell Medical College-New York Presbyterian Hospital — New York, New York, United States
- Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States
- Oncology Associates of Oregon — Springfield, Oregon, United States
- SCRI-Tennessee Oncology — Nashville, Tennessee, United States
- The Methodist Hospital Research Institute; Academic Office of Clinical Trials — Houston, Texas, United States
- St James University Hospital — Leeds, United Kingdom
- Leicester Royal Infirmary NHS Trust — Leicester, United Kingdom
- Barts and The London School of Medicine and Dentistry; Queen Mary, University of London — London, United Kingdom
Full record on ClinicalTrials.gov
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