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

NCT ID: NCT01868893

Last Updated: 2017-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2014-01-31

Brief Summary

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.

Conditions

Chronic Lymphocytic Leukemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Obinutuzumab + Chlorambucil

Obinutuzumab was administered intravenously for 6 cycles (28-day cycles) as: 100 mg on Day 1, 900 mg on Day 2, and 1000 mg on Days 8 and 15 for Cycle 1; and 1000 mg on Day 1 of Cycles 2 to 6. Chlorambucil was administered orally at a dose of 0.5 mg/kg body weight on Days 1 and 15 for Cycles 1 through 6 (28-day cycles).

Group Type: EXPERIMENTAL

Obinutuzumab

Intervention Type: DRUG

Chlorambucil

Intervention Type: DRUG

Interventions

Obinutuzumab

Intervention Type: DRUG

Chlorambucil

Intervention Type: DRUG

Other Intervention Names

RO 5072759, GA101

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Genentech, Inc.

Locations

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

Countries

United States

Other Identifiers

ML28979

Identifier Type: -

Identifier Source: org_study_id