An Expanded Access, Open-Label Study of Obinutuzumab (GA101) Plus Chlorambucil in Patients With Previously Untreated Chronic Lymphocytic Leukemia

Completed · Phase 2

Conditions studied: Chronic Lymphocytic Leukemia

In brief

This is a multicenter, open-label, single-arm, expanded access treatment study designed to provide obinutuzumab to patients with previously untreated Chronic Lymphocytic Leukemia (CLL) in combination with chlorambucil and to evaluate the safety and efficacy of obinutuzumab administered in combination with chlorambucil. This study will enroll patients with previously untreated CD20-positive CLL requiring treatment according to the IWCLL guidelines (Hallek et al 2008), as assessed by the investigator.

Key facts

Study ID

NCT01868893

Run by

Genentech, Inc.

People needed

20

Starts

2013-08-01

Expected to finish

2014-01-01

Last updated by the study team

2017-04-17

Who can join

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

You may qualify if…

• Confirmed diagnosis of CD20-positive CLL (per IWCLL guidelines, Hallek et al 2008)
• Previously untreated CLL requiring treatment according to the IWCLL guidelines (Hallek et al 2008), as assessed by the investigator
• Adequate baseline bone marrow function unless it due to underlying CLL disease No previous treatment for CLL by chemotherapy, radiotherapy, or immunotherapy
• Patients who are not appropriate to receive more intensive chemotherapy in the judgment of the investigator
• Life expectancy of > 6 months

You may not qualify if…

• Treatment with any other investigational agent or participation in another clinical trial within 28 days prior to the start of Cycle 1
• Transformation of CLL to aggressive B-cell malignancy History of severe allergic or anaphylactic reactions to monoclonal antibody therapy
• Known hypersensitivity to chlorambucil or any of its excipients
• History of other malignancy that could affect compliance with the protocol or interpretation of results Known active bacterial, viral, fungal, mycobacterial, or other infection (excluding fungal infections of nail beds) or any major episode of infection requiring treatment with IV antibiotics or hospitalization (related to the completion of the course of antibiotics) within 4 weeks before the start of Cycle 1
• Major surgery (within 4 weeks prior to the start of Cycle 1), other than for diagnosis
• Known infection with human immunodeficiency virus (HIV) or Human T-Cell Leukemia Virus 1 (HTLV-1) seropositive status
• Positive hepatitis serology
• Women who are pregnant or lactating
• Fertile men or women of childbearing potential unless 1) surgically sterile or 2) using an adequate measure of contraception such as oral contraceptives, intrauterine device, or barrier method of contraception in conjunction with spermicidal jelly
• Effective contraception is required while receiving obinutuzumab. For women, effective contraception is required to continue for >= 12 months after the last dose of obinutuzumab. For men, effective contraception is required to continue for 6 months after the last dose of chlorambucil treatment.
• Vaccination with a live vaccine a minimum of 28 days prior to the start of Cycle 1

Where it is running

• Clearview Cancer Institute — Huntsville, Alabama, United States
• Highlands Oncology Group — Rogers, Arkansas, United States
• University of California San Diego — La Jolla, California, United States
• Bay Area Cancer Research Group, LLC — Pleasant Hill, California, United States
• Cancer Center of Central Conn. — Southington, Connecticut, United States
• Peachtree Hematology & Oncology Consultants, Pc — Atlanta, Georgia, United States
• Northwest Georgia Oncology Centers PC - Marietta — Marietta, Georgia, United States
• Kootenai Cancer Center — Coeur d'Alene, Idaho, United States
• Illinois Cancer Care, P.C. - Galesburg — Galesburg, Illinois, United States
• Joliet Oncology Hematology Associates, Ltd. — Joliet, Illinois, United States
• Illinois Cancer Care — Peoria, Illinois, United States
• Center for Cancer Care — Goshen, Indiana, United States
• Indiana University Melvin and Bren Simon Cancer Center — Indianapolis, Indiana, United States
• Horizon Oncology Research, Inc. — Lafayette, Indiana, United States
• San Juan Oncology Associates — Farmington, New Mexico, United States
• Mark H. Zangmeister Center — Columbus, Ohio, United States
• Charleston Hematology Oncology — Charleston, South Carolina, United States
• Northwest Medical Specialties — Tacoma, Washington, United States
• Vince Lombardi Cancer Clinic Pharmacy — Green Bay, Wisconsin, United States

Full record on ClinicalTrials.gov

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