Spots Global Cancer Trial Database for A Study of Venetoclax in Combination With Obinutuzumab in Participants With Chronic Lymphocytic Leukemia
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Trial Identification
Brief Title: A Study of Venetoclax in Combination With Obinutuzumab in Participants With Chronic Lymphocytic Leukemia
Official Title: A Phase Ib Multicenter Dose-Finding and Safety Study of Venetoclax and Obinutuzumab in Patients With Relapsed or Refractory or Previously Untreated Chronic Lymphocytic Leukemia
Study ID: NCT01685892
Conditions
Study Description
Brief 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).
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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
Contact Details
Name: Clinical Trials
Affiliation: Genentech, Inc.
Role: STUDY_DIRECTOR
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