A Study of Venetoclax in Combination With Obinutuzumab in Participants With Chronic Lymphocytic Leukemia



Status:Active, not recruiting
Conditions:Blood Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/8/2019
Start Date:November 29, 2012
End Date:March 30, 2019

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A Phase Ib Multicenter Dose-Finding and Safety Study of Venetoclax and Obinutuzumab in Patients With Relapsed or Refractory or Previously Untreated Chronic Lymphocytic Leukemia

This multi-center, open-label, dose-finding study will evaluate the safety and
pharmacokinetics as well as the preliminary efficacy of venetoclax (GDC-0199; ABT-199)
administered in combination with obinutuzumab to participants with relapsed/refractory or
previously untreated chronic lymphocytic leukemia (CLL). The study is comprised of two stages
for each participant population: a dose-finding stage and a safety-expansion stage. The
dose-finding stage will explore multiple doses of venetoclax to be used in combination with a
fixed dose of obinutuzumab. The dose-finding stage will also explore two schedules for drug
administration, Schedule A (venetoclax introduced before obinutuzumab) and Schedule B
(venetoclax introduced after obinutuzumab).


Inclusion Criteria:

- Diagnosis of relapsing/refractory or previously untreated chronic lymphocytic leukemia

- Eastern Cooperative Oncology Group (ECOG) performance score of less than or equal to
(
- Adequate bone marrow function

- Adequate coagulation, renal and hepatic function

- For all participants, agreement to remain abstinent or use contraceptive methods that
result in a failure rate of less than (<) 1% per year during the treatment period and
for at least 90 days (30 days for women) after the last dose of venetoclax or 18
months after the last dose of obinutuzumab, whichever is longer

Exclusion Criteria:

- Participants who have undergone allogenic stem cell transplant are ineligible unless
they meet the following criteria, a) participants who are off all immunosuppressive
therapy, b) participants who have no signs and/or symptoms of acute or chronic graft
versus host disease, or c) participants must have appropriate hematology counts

- Infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C

- Uncontrolled autoimmune hemolytic anemia or thrombocytopenia

- Investigational or anti-cancer therapy within 5 half-lives prior to the first dose of
study drug

- History of significant renal, neurologic, psychiatric, endocrinologic, metabolic,
immunologic, cardiovascular, or hepatic disease
We found this trial at
12
sites
Buffalo, New York 14263
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Columbus, OH
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Denver, CO
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Houston, Texas 77030
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Houston, TX
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Houston, TX
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La Jolla, California 92093
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La Jolla, CA
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Leeds,
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Morgantown, West Virginia 26506
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Morgantown, WV
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Nashville, Tennessee 37203
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Nashville, TN
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New York, NY
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Sarasota, Florida 34232
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Sarasota, FL
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Springfield, Oregon 97477
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Springfield, OR
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