Study of Ibrutinib Combined With Venetoclax in Subjects With Mantle Cell Lymphoma (SYMPATICO)



Status:Recruiting
Conditions:Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/3/2019
Start Date:May 12, 2017
End Date:September 2022
Contact:Divya Chari
Email:medinfo@pcyc.com
Phone:+1-855-427-8846

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Phase 3 Study of Ibrutinib in Combination With Venetoclax in Subjects With Mantle Cell Lymphoma

This Phase 3 multinational, randomized, double-blind study is designed to compare the
efficacy and safety of the combination of ibrutinib and venetoclax vs. ibrutinib and placebo
in subjects with MCL.


Inclusion Criteria:

- Pathologically confirmed MCL (in tumor tissue), with documentation of either
overexpression of cyclin D1 in association with other relevant markers (eg, CD19,
CD20, PAX5, CD5) or evidence of t(11;14) as assessed by cytogenetics, fluorescent in
situ hybridization (FISH), or polymerase chain reaction (PCR)

- At least 1 measurable site of disease on cross-sectional imaging (CT/PET)

- At least 1, but no more than 5, prior treatment regimens for MCL

- Failure to achieve at least partial response (PR) with, or documented disease
progression after, the most recent treatment regimen

- Subjects must have adequate fresh or paraffin embedded tissue

Exclusion Criteria:

- History or current evidence of central nervous system lymphoma

- Concurrent enrollment in another therapeutic investigational study or prior therapy
with ibrutinib or other BTK inhibitors

- Prior treatment with venetoclax or other BCL2 inhibitors
We found this trial at
18
sites
Louisville, Kentucky 40207
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Louisville, KY
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4100 John R
Detroit, Michigan 48201
800-527-6266
Barbara Ann Karmanos Cancer Institute Karmanos is based in southeast Michigan, in midtown Detroit, and...
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Detroit, MI
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24 Sturtevant St
Orlando, Florida 32806
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Orlando, FL
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Charlotte, North Carolina 28211
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Charlotte, NC
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Chattanooga, Tennessee 37404
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Chattanooga, TN
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Duarte, California 91010
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Duarte, CA
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Durham, NC
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92 2nd St
Hackensack, New Jersey 07601
(201) 996-5900
John Theurer Cancer Center at the Hackensack University Medical Center The mission of the John...
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Hackensack, NJ
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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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1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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Houston, TX
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Kansas City, MO
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11234 Anderson St
Loma Linda, California 92354
(909) 558-4000
Loma Linda University Medical Center An outgrowth of the original Sanitarium on the hill in...
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Loma Linda, CA
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Los Angeles, California 90095
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Los Angeles, CA
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101 Nicolls Road
New York, New York 11794
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New York, NY
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1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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New York, NY
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Seattle, Washington 98104
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Seattle, WA
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Tucson, AZ
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Westwood, KS
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