Status:
COMPLETED
An Expanded Access, Open-Label Study of Obinutuzumab (GA101) Plus Chlorambucil in Patients With Previously Untreated Chronic Lymphocytic Leukemia
Lead Sponsor:
Genentech, Inc.
Conditions:
Chronic Lymphocytic Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01868893
Start Date
August 1 2013
End Date
January 1 2014
Last Update
April 17 2017
Active Locations (19)
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1
Clearview Cancer Institute
Huntsville, Alabama, United States, 35805
2
Highlands Oncology Group
Rogers, Arkansas, United States, 72758
3
University of California San Diego
La Jolla, California, United States, 92093
4
Bay Area Cancer Research Group, LLC
Pleasant Hill, California, United States, 94523