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

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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.


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
Tampa, Florida 33612
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Atlanta, Georgia 30322
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Atlanta, GA
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4102 Galvan
Buenos Aires, C1431
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Buenos Aires,
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Cherry Hill, New Jersey
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Cherry Hill, NJ
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2799 W Grand Blvd
Detroit, Michigan 48202
(313) 916-2600
Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
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Detroit, MI
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Duarte, California 91010
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Duarte, CA
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477 North El Camino Real
Encinitas, California 92024
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Encinitas, CA
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477 North El Camino Real
Encinitas, California 92024
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Encinitas, CA
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Gilbert, Arizona 85234
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Gilbert, AZ
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1 Ingalls Dr
Harvey, Illinois 60426
(708) 333-2300
Ingalls Memorial Hospital As the area's only independent not-for-profit healthcare system, Ingalls has the ability...
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Harvey, IL
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535 Barnhill Dr
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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Indianapolis, IN
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9500 Gilman Drive
La Jolla, California 92093
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La Jolla, CA
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Lubbock, Texas 79410
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Lubbock, TX
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101 Nicolls Road
New York, New York 10021
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New York, NY
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12630 Monte Vista Road
Poway, California 92064
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Poway, CA
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