A Study of Venetoclax in Combination With Bendamustine + Rituximab or Bendamustine + Obinutuzumab in Participants With Relapsed/Refractory or Previously Untreated Chronic Lymphocytic Leukemia (CLL)

• Status: Completed
• Trial end date: 2020-08-11
• Target enrollment: 0
• Participant gender: All

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.

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

Details

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

Criteria

Inclusion Criteria:

• Diagnosis of relapsing/refractory or previously untreated CLL

• Eastern Cooperative Oncology Group (ECOG) performance score of less than equal to (
• 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