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) |
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
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
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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University of Chicago One of the world's premier academic and research institutions, the University of...
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Barbara Ann Karmanos Cancer Institute Karmanos is based in southeast Michigan, in midtown Detroit, and...
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University of Miami A private research university with more than 15,000 students from around the...
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1211 Medical Center Dr
Nashville, Tennessee 37232
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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Univ of Rochester Medical Center One of the nation's top academic medical centers, the University...
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1365 Clifton Rd NE
Atlanta, Georgia 30322
Atlanta, Georgia 30322
(404) 778-1900
Winship Cancer Institute at Emory University Winship Cancer Institute of Emory University is Georgia
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Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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Columbus, Ohio 43202
Principal Investigator: Samantha M. Jaglowski, MD, MPH
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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
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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3322 West End Avenue
Nashville, Tennessee 37203
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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450 Serra Mall
Stanford, California 94305
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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