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
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...
Click here to add this to my saved trials
University of Chicago One of the world's premier academic and research institutions, the University of...
Click here to add this to my saved trials
Barbara Ann Karmanos Cancer Institute Karmanos is based in southeast Michigan, in midtown Detroit, and...
Click here to add this to my saved trials
University of Miami A private research university with more than 15,000 students from around the...
Click here to add this to my saved trials
Univ of Rochester Medical Center One of the nation's top academic medical centers, the University...
Click here to add this to my saved trials
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
Click here to add this to my saved trials
Click here to add this to my saved trials
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
Click here to add this to my saved trials
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
Click here to add this to my saved trials
Columbus, Ohio 43202
Principal Investigator: Samantha M. Jaglowski, MD, MPH
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
Click here to add this to my saved trials
Click here to add this to my saved trials
Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
Click here to add this to my saved trials
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...
Click here to add this to my saved trials
Los Angeles, California 90095
Principal Investigator: John Timmerman, MD
Click here to add this to my saved trials
Click here to add this to my saved trials
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...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
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...
Click here to add this to my saved trials
Click here to add this to my saved trials