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
Philadelphia, Pennsylvania 19111
Principal Investigator: Henry Fung, MD
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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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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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Bordeaux,
Principal Investigator: Noel Miliped, Prof. MD
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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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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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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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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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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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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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