Spots Global Cancer Trial Database for A Study of Venetoclax in Combination With Bendamustine + Rituximab or Bendamustine + Obinutuzumab in Participants With Relapsed/Refractory or Previously Untreated Chronic Lymphocytic Leukemia (CLL)
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Trial Identification
Brief Title: A Study of Venetoclax in Combination With Bendamustine + Rituximab or Bendamustine + Obinutuzumab in Participants With Relapsed/Refractory or Previously Untreated Chronic Lymphocytic Leukemia (CLL)
Official Title: A Phase IB, Open-Label Study Evaluating the Safety and Pharmacokinetics of Venetoclax (GDC-0199, ABT-199) in Combination With Bendamustine+Rituximab (BR) or Bendamustine+Obinutuzumab (BG) in Patients With Relapsed/Refractory or Previously Untreated Chronic Lymphocytic Leukemia
Study ID: NCT01671904
Conditions
Study Description
Brief Summary: This multi-center, open-label, dose-finding study will evaluate the safety and pharmacokinetics of venetoclax (GDC-0199, ABT-199) administered in combination with bendamustine and rituximab (BR) (MabThera/Rituxan) or bendamustine and obinutuzumab (BG) to participants with first-line (1L)/previously untreated or relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL). The study will explore two venetoclax combination regimens in participants with 1L CLL: BR+venetolax (V) and BG+V. Participants with R/R CLL will be administered BR+V.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of California San Diego Medical Center, La Jolla, California, United States
Ingalls Hospital; Cancer Clinical Trials, Harvey, Illinois, United States
Karmanos Cancer Institute, Detroit, Michigan, United States
North Star Lodge, Yakima, Washington, United States
Hopital Claude Huriez, Lille, , France
Hopital Saint Eloi, Montpellier, , France
Centre Hospitalier Lyon Sud, Pierre Benite, , France
Centre Henri Becquerel, Rouen, , France
Apotheke des Universitätsklinikums Freiburg, Freiburg, , Germany
Universitatsklinik Koln, Köln, , Germany
Klinikum Schwabing, München, , Germany
Universtitätsklinikum Ulm; Klinik für Innere Medizin III, Ulm, , Germany
Contact Details
Name: Clinical Trials
Affiliation: Genentech, Inc.
Role: STUDY_DIRECTOR
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