Chronic Lymphocytic Leukemia Clinical Trial
A Study of Venetoclax in Combination With Bendamustine + Rituximab or Bendamustine + Obinutuzumab in Participants With Relapsed/Refractory or Previously Untreated Chronic Lymphocytic Leukemia (CLL)
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) leukemia-cll/" >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.
Eligibility Criteria
Inclusion Criteria:
Diagnosis of relapsing/refractory or previously untreated CLL
Eastern Cooperative Oncology Group (ECOG) performance score of less than equal to (=) 1
Adequate bone marrow function
Adequate coagulation, renal and hepatic function
Hematological values within the limits independent of growth factor support or transfusion unless cytopenia is caused by the underlying disease, i.e., no evidence of additional bone marrow dysfunction (e.g., myelodysplastic syndrome, hypoplastic bone marrow)
Exclusion Criteria:
Participants received an allogeneic stem cell transplant
Known human immunodeficiency virus (HIV) positivity
Uncontrolled autoimmune hemolytic anemia or thrombocytopenia
Positive test results for chronic hepatitis B infection and hepatitis C virus (HCV)
Received any anti-cancer therapy including chemotherapy or radiotherapy, steroid therapy for anti-neoplastic intent, and investigational therapy, including targeted small molecule agents within 28 days prior to the first dose of study drug or has not recovered to less than Grade 2 clinically significant adverse effect(s)/toxicity(s) of the previous therapy
Significant history of renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, cardiovascular, or hepatic disease
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There are 12 Locations for this study
La Jolla California, 92093, United States
Harvey Illinois, 60426, United States
Detroit Michigan, 48201, United States
Yakima Washington, 98902, United States
Lille , 59037, France
Montpellier , 34295, France
Pierre Benite , 69495, France
Rouen , 76038, France
Freiburg , 79106, Germany
Köln , 50924, Germany
München , 80804, Germany
Ulm , 89081, Germany
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