A Phase 2 Multicenter Study Evaluating Subjects With Relapsed/Refractory Mantle Cell Lymphoma



Status:Recruiting
Conditions:Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/3/2019
Start Date:November 2015
End Date:January 2035
Contact:Medical Information
Email:medinfo@kitepharma.com
Phone:1-844-454-5483(1-844-454-KITE)

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A Phase 2 Multicenter Study Evaluating the Efficacy of KTE-X19 in Subjects With Relapsed/Refractory Mantle Cell Lymphoma (ZUMA-2)

Study KTE-C19-102 is a phase 2, multicenter, open-label study evaluating the efficacy of
KTE-X19 in subjects with Relapsed/Refractory MCL


Key Inclusion Criteria:

Up to 5 prior regimens for mantle cell lymphoma (MCL). Prior therapy must have included:

- Anthracycline or bendamustine-containing chemotherapy and

- Anti-CD20 monoclonal antibody therapy and

- Ibrutinib or acalabrutinib

At least 1 measurable lesion

Platelet count ≥ 75,000/uL

Creatinine clearance (as estimated by Cockcroft Gault) > 60 mL/min

Cardiac ejection fraction ≥ 50%, no evidence of pericardial effusion as determined by an
echocardiogram (ECHO), and no clinically significant electrocardiogram (ECG) findings

Baseline oxygen saturation >92% on room air.

Key Exclusion Criteria:

- Known history of infection with HIV or hepatitis B (HBsAG positive) or hepatitis C
virus (anti-HCV positive). A history of hepatitis B or hepatitis C is permitted if the
viral load is undetectable per standard serological and genetic testing

- History of a seizure disorder, cerebrovascular ischemia/hemorrhage, dementia,
cerebellar disease, cerebral edema, posterior reversible encephalopathy syndrome, or
any autoimmune disease with central nervous system (CNS) involvement

- Presence of fungal, bacterial, viral, or other infection that is uncontrolled or
requiring IV antimicrobials for management.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
We found this trial at
26
sites
5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
University of Chicago One of the world's premier academic and research institutions, the University of...
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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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Miami, Florida 33124
(305) 284-2211
Principal Investigator: Amer Beitinjaneh
University of Miami A private research university with more than 15,000 students from around the...
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Miami, FL
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Principal Investigator: Olalekan Oluwole, MD
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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Nashville, TN
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601 Elmwood Avenue
Rochester, New York 14642
(585) 275-2100
Univ of Rochester Medical Center One of the nation's top academic medical centers, the University...
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Rochester, NY
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1365 Clifton Rd NE
Atlanta, Georgia 30322
(404) 778-1900
Winship Cancer Institute at Emory University Winship Cancer Institute of Emory University is Georgia
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Atlanta, GA
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Bordeaux,
Principal Investigator: Noel Miliped, Prof. MD
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Bordeaux,
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Boston, MA
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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Cleveland, OH
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Columbus, Ohio 43202
Principal Investigator: Samantha M. Jaglowski, MD, MPH
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Dallas, TX
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Denver, Colorado 80218
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Duarte, California 91010
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Phone: 919-681-4769
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Gilbert, Arizona 85234
Principal Investigator: Javier Munoz, MD, FACP
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Gilbert, AZ
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30 Prospect Ave
Hackensack, New Jersey 07601
(201) 996-2000
Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
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1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
Principal Investigator: Michael (Luhua) Wang, MD
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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Los Angeles, California 90095
Principal Investigator: John Timmerman, MD
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Maywood, Illinois 60153
Principal Investigator: Patrick Stiff, MD
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Maywood, IL
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3322 West End Avenue
Nashville, Tennessee 37203
(615)329-SCRI (7274)
Sarah Cannon Research Institute Sarah Cannon Research Institute (SCRI) is a global strategic research organization...
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Philadelphia, Pennsylvania 19111
Principal Investigator: Henry Fung, MD
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Portland, OR
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San Antonio, Texas 78229
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Seattle, Washington 98104
Phone: 206-215-2338
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Seattle, WA
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450 Serra Mall
Stanford, California 94305
(650) 723-2300
Principal Investigator: David Miklos, MD, PhD
Stanford University Stanford University, located between San Francisco and San Jose in the heart of...
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Tampa, Florida 33612
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