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.

View Eligibility Criteria

Eligibility 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

Study is for people with:

Chronic Lymphocytic Leukemia

Phase:

Phase 1

Estimated Enrollment:

84

Study ID:

NCT01671904

Recruitment Status:

Completed

Sponsor:

Genentech, Inc.

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There are 12 Locations for this study

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University of California San Diego Medical Center
La Jolla California, 92093, United States
Ingalls Hospital; Cancer Clinical Trials
Harvey Illinois, 60426, United States
Karmanos Cancer Institute
Detroit Michigan, 48201, United States
North Star Lodge
Yakima Washington, 98902, United States
Hopital Claude Huriez
Lille , 59037, France
Hopital Saint Eloi
Montpellier , 34295, France
Centre Hospitalier Lyon Sud
Pierre Benite , 69495, France
Centre Henri Becquerel
Rouen , 76038, France
Apotheke des Universitätsklinikums Freiburg
Freiburg , 79106, Germany
Universitatsklinik Koln
Köln , 50924, Germany
Klinikum Schwabing
München , 80804, Germany
Universtitätsklinikum Ulm; Klinik für Innere Medizin III
Ulm , 89081, Germany

How clear is this clinincal trial information?

Study is for people with:

Chronic Lymphocytic Leukemia

Phase:

Phase 1

Estimated Enrollment:

84

Study ID:

NCT01671904

Recruitment Status:

Completed

Sponsor:


Genentech, Inc.

How clear is this clinincal trial information?

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