A Study of GDC-0199 (ABT-199) in Combination With Obinutuzumab in Patients With Chronic Lymphocytic Leukemia



Status:Recruiting
Conditions:Blood Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 65
Updated:2/8/2015
Start Date:November 2012
End Date:November 2016
Contact:Reference Study ID Number: GP28331 www.roche.com/about_roche/roche_worldwide.htm
Email:global.rochegenentechtrials@roche.com
Phone:888-662-6728 (U.S. Only)

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A Phase Ib Multicenter Dose-Finding And Safety Study Of GDC-0199 And Obinutuzumab in Patients With Relapsed Or Refractory Or Previously Untreated Chronic Lymphocytic Leukemia

This multi-center, open-label, dose-finding study will evaluate the safety and
pharmacokinetics of GDC-0199 (ABT-199) administered in combination with obinutuzumab to
patients with relapsed/refractory or previously untreated chronic lymphocytic leukemia. The
anticipated time on study treatment is 6 months.

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Inclusion Criteria:

- Diagnosis of relapsing/refractory or previously untreated chronic lymphocytic
leukemia

- Eastern Cooperative Oncology Group (ECOG) performance score of >/=1

- Adequate bone marrow function

- Adequate renal and hepatic function

Exclusion Criteria:

- Patient received an allogeneic stem cell transplant

- Infection with human immunodeficiency virus, hepatitis B, or hepatitis C

- Uncontrolled autoimmune hemolytic anemia or thrombocytopenia

- Investigational or anti-cancer therapy within 14 days of study start

- History of significant renal, neurologic, psychiatric, endocrinologic, metabolic,
immunologic, cardiovascular, or hepatic disease
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