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

Completed · Phase 1

Conditions studied: Chronic Lymphocytic Leukemia

In brief

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.

Key facts

Study ID

NCT01671904

Run by

Genentech, Inc.

People needed

84

Starts

2014-01-13

Expected to finish

2020-08-11

Last updated by the study team

2020-10-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• 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-Bénite, France
• Centre Henri Becquerel — Rouen, France
• Universitatsklinik Koln — Cologne, Germany
• Apotheke des Universitätsklinikums Freiburg — Freiburg im Breisgau, Germany
• Klinikum Schwabing — München, Germany
• Universtitätsklinikum Ulm; Klinik für Innere Medizin III — Ulm, Germany

Full record on ClinicalTrials.gov

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