A Study to Compare the Efficacy and Safety of Obinutuzumab + Venetoclax (GDC-0199) Versus Obinutuzumab + Chlorambucil in Participants With Chronic Lymphocytic Leukemia
Status: | Active, not recruiting |
---|---|
Conditions: | Blood Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 2/23/2019 |
Start Date: | December 31, 2014 |
End Date: | September 1, 2021 |
A Prospective, Open-Label, Multicenter Randomized Phase III Trial to Compare The Efficacy and Safety of A Combined Regimen of Obinutuzumab and Venetoclax (GDC-0199/ABT-199) Versus Obinutuzumab and Chlorambucil in Previously Untreated Patients With CLL and Coexisting Medical Conditions
This open-label, multicenter, randomized Phase III study is designed to compare the efficacy
and safety of a combined regimen of obinutuzumab and venetoclax versus obinutuzumab +
chlorambucil in participants with chronic lymphocytic leukemia (CLL) and coexisting medical
conditions. The anticipated time on study treatment will be approximately one year and the
follow-up period will be up to 5 years.
and safety of a combined regimen of obinutuzumab and venetoclax versus obinutuzumab +
chlorambucil in participants with chronic lymphocytic leukemia (CLL) and coexisting medical
conditions. The anticipated time on study treatment will be approximately one year and the
follow-up period will be up to 5 years.
Inclusion Criteria:
- Documented previously untreated CLL according to the International Workshop on Chronic
Lymphocytic Leukemia (IWCLL) criteria
- CLL requiring treatment according to IWCLL criteria
- Total Cumulative Illness Rating Scale (CIRS score) greater than (>) 6
- Adequate marrow function independent of growth factor or transfusion support within 2
weeks of screening as per protocol, unless cytopenia is due to marrow involvement of
CLL
- Adequate liver function
- Life expectancy > 6 months
- Agreement to use highly effective contraceptive methods per protocol
Exclusion Criteria:
- Transformation of CLL to aggressive Non-Hodgkin's lymphoma (Richter's transformation
or pro-lymphocytic leukemia)
- Known central nervous system involvement
- Participants with a history of confirmed progressive multifocal leukoencephalopathy
(PML)
- An individual organ/ system impairment score of 4 as assessed by the CIRS definition
limiting the ability to receive the treatment regimen of this trial with the exception
of eyes, ears, nose, throat organ system
- Participants with uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia
- Inadequate renal function
- History of prior malignancy, except for conditions as listed in the protocol if
patients have recovered from the acute side effects incurred as a result of previous
therapy
- Use of investigational agents or concurrent anti-cancer treatment within the last 4
weeks of registration
- Participants with active bacterial, viral, or fungal infection requiring systemic
treatment within the last two months prior to registration
- History of severe allergic or anaphylactic reactions to humanized or murine monoclonal
antibodies or known sensitivity or allergy to murine products
- Hypersensitivity to chlorambucil, obinutuzumab, or venetoclax or to any of the
excipients
- Pregnant women and nursing mothers
- Positive test results for chronic hepatitis B virus (HBV) infection (defined as
positive hepatitis B surface antigen [HBsAg] serology) or positive test result for
hepatitis C (hepatitis C virus [HCV] antibody serology testing)
- Participants with known infection with human immunodeficiency virus (HIV) or human
T-cell leukemia virus-1 (HTLV-1)
- Requires the use of warfarin, marcumar, or phenprocoumon
- Received agents known to be strong and moderate Cytochrome P450 3A inhibitors or
inducers within 7 days prior to the first dose of study drug
We found this trial at
15
sites
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Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
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Ingalls Memorial Hospital As the area's only independent not-for-profit healthcare system, Ingalls has the ability...
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535 Barnhill Dr
Indianapolis, Indiana 46202
Indianapolis, Indiana 46202
(888) 600-4822
Indiana University Melvin and Bren Simon Cancer Center At the IU Simon Cancer Center, more...
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