Spots Global Cancer Trial Database for CTL019 Out of Specification MAP for ALL or DLBCL Patients
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Trial Identification
Brief Title: CTL019 Out of Specification MAP for ALL or DLBCL Patients
Official Title: Managed Access Program (MAP) Cohort Treatment Plan CCTL019B2003I to Provide Access for Patients With Out of Specification Leukapheresis Product and/or Out of Specification Manufactured Tisagenlecleucel (CTL019; Kymriah®)
Study ID: NCT03601442
Interventions
Study Description
Brief Summary: Managed Access Program (MAP) to provide access to CTL019, for acute lymphoblastic leukemia (ALL) or diffuse large b-cell lymphoma (DLBCL) patients with out of specification leukapheresis product and/or manufactured tisagenlecleucel out of specification for commercial release.
Detailed Description: The purpose of this Managed Access Program (MAP) Treatment Plan is to provide access to CTL019, for acute lymphoblastic leukemia (ALL) or diffuse large b-cell lymphoma (DLBCL) patients with out of specification leukapheresis product and/or manufactured tisagenlecleucel out of specification for commercial release where no overwhelming safety concerns has been identified for manufacture and release of the out of specification product.
Eligibility
Minimum Age: 1 Day
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Banner MDACC, Gilbert, Arizona, United States
University of Arizona Cancer Center, Phoenix, Arizona, United States
Banner University of Arizona Medical Center, Phoenix, Arizona, United States
Phoenix Children's Hospital, Phoenix, Arizona, United States
Phoenix Childrens Hospital, Phoenix, Arizona, United States
Banner Uni Medical Center Tucson, Tucson, Arizona, United States
City of Hope National Medical Center Hematology&HematCellTransplant, Duarte, California, United States
City of Hope, Duarte, California, United States
Children's Hospital Los Angeles CRFB002H2301, Los Angeles, California, United States
Children's Hospital Los Angeles, Los Angeles, California, United States
Childrens Hospital Los Angeles, Los Angeles, California, United States
Mattel Childrens Hospital UCLA, Los Angeles, California, United States
University of California at Los Angeles UCLA, Los Angeles, California, United States
Lucile Packard Children s Hospital Stanford University, Palo Alto, California, United States
Lucile Packard Childrens Hospital, Palo Alto, California, United States
Stanford University Medical Center, Palo Alto, California, United States
UC San Diego, San Diego, California, United States
University of California at San Diego, Moores Cancer Ctr UCSD, San Diego, California, United States
Rady Children s Hospital Dept of Oncology, San Diego, California, United States
Rady Childrens Hospital, San Diego, California, United States
Ucsf Benioff Childrens Hospital Pediatric Hematology Oncology, San Francisco, California, United States
University of Califronia San Francisco, San Francisco, California, United States
University of California, Los Angeles, Santa Monica, California, United States
Stanford Healthcare, Stanford, California, United States
Children's Hospital Colorado, Denver, Colorado, United States
Yale Cancer Center, New Haven, Connecticut, United States
University of Miami Hospital, Miami, Florida, United States
JHMI All Children s Hospital, Saint Petersburg, Florida, United States
Emory University School of Medicine Emory University (12), Atlanta, Georgia, United States
Emory University School of Medicine/Winship Cancer Institute Winship Cancer Center, Atlanta, Georgia, United States
Emory University School of Medicine/Winship Cancer Institute, Atlanta, Georgia, United States
Children's Healthcare of Atlanta Cellular Therapies Lab, Atlanta, Georgia, United States
Northside Hospital, Atlanta, Georgia, United States
Ann and Robert H Lurie Childrens Hospital of Chicago, Chicago, Illinois, United States
Northwestern, Chicago, Illinois, United States
University of Illinois at Chicago, Chicago, Illinois, United States
University of CHicago Comer Children's Hospital Regulatory, Chicago, Illinois, United States
University of Chicago, Chicago, Illinois, United States
Healthwatch Plaza Research Associates, Louisville, Kentucky, United States
University of Maryland Medical Center UMMC, Baltimore, Maryland, United States
University of Maryland Medical Center, Baltimore, Maryland, United States
University of Maryland, Baltimore, Maryland, United States
Johns Hopkins Outpatient Center, Baltimore, Maryland, United States
Johns Hopkins University Hospital, Baltimore, Maryland, United States
Tufts Medical Center, Boston, Massachusetts, United States
Massachusetts General Hospital Cancer Center, Boston, Massachusetts, United States
Massachusetts General Hospital DF/HCC institutions, Boston, Massachusetts, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
MGH Cancer Center MGH Cancer Center, Boston, Massachusetts, United States
MGH Cancer Center, Boston, Massachusetts, United States
Dana Farber Cancer Institute Dana Farber Cancer Institute, Boston, Massachusetts, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
University of Michigan IRB, Ann Arbor, Michigan, United States
University of Michigan Medical Center, Ann Arbor, Michigan, United States
University of Michigan Health System, Ann Arbor, Michigan, United States
Karmanos Cancer Institute, Detroit, Michigan, United States
Moffitt Cancer Center, Detroit, Michigan, United States
Wayne State University - Karmanos Cancer Institute, Detroit, Michigan, United States
Henry Ford Hospital Henry Ford, Detroit, Michigan, United States
University of Minnesota Masonic Childrens Hospital, Minneapolis, Minnesota, United States
University of Minnesota, Minneapolis, Minnesota, United States
Mayo CLinic, Rochester, Minnesota, United States
WUSTL Jewish Barnes, Saint Louis, Missouri, United States
Hackensack University Medical Center Hackensack UMC, Hackensack, New Jersey, United States
Hackensack University Medical Center Onc Dept, Hackensack, New Jersey, United States
Robert Wood Johnson Medical School, New Brunswick, New Jersey, United States
Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
Roswell Park Cancer Institute Rosewell, Buffalo, New York, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
Memorial Sloan Kettering, New York, New York, United States
Memorial Sloan Kettering Cancer Center MSKCC, New York, New York, United States
Memorial Sloan Kettering Cancer Center Oncology, New York, New York, United States
Columbia University Medical Center New York Presbyterian CUMC Research Pharmacy, New York, New York, United States
Columbia University Medical Center New York Presbyterian Neuroendocrine Unit, New York, New York, United States
Memorial Sloan Kettering Cancer Center MSKCC (9), New York, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
University of North Carolina Chapel Hill Physician Office Building, Chapel Hill, North Carolina, United States
University of North Carolina Health System, Chapel Hill, North Carolina, United States
Atrium Heath, Charlotte, North Carolina, United States
Duke University Medical Center Dept. of DUMC (4), Durham, North Carolina, United States
Duke University Medical Center, Durham, North Carolina, United States
Cincinnati Children s Hospital Medical Center, Cincinnati, Ohio, United States
Cincinnati Childrens Hospital, Cincinnati, Ohio, United States
Oncology Hematology Care Inc Drug Shipment, Cincinnati, Ohio, United States
University Hospitals Cleveland Medical Center Univ. Hospitals of Cleveland, Cleveland, Ohio, United States
Nationwide Childrens Hospital Center, Columbus, Ohio, United States
OSU Wexner MC James CH, Columbus, Ohio, United States
The Ohio State University Hospitals Clinic The Ohio State University, Columbus, Ohio, United States
The Ohio State University Hospitals Clinic, Columbus, Ohio, United States
The Ohio State University Regulatory, Columbus, Ohio, United States
The Ohio State University Comprehensive Cancer Center Ohio State UMC James Cancer Ct, Columbus, Ohio, United States
Hematology Oncology Center, Inc., Elyria, Ohio, United States
Oregon Health Sciences University, Portland, Oregon, United States
Oregon Health and Science University, Portland, Oregon, United States
OHSU, Portland, Oregon, United States
Oregon Health and Science University, Portland, Oregon, United States
Childrens Hospital of Philadelphia CTRB 3006, Philadelphia, Pennsylvania, United States
Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, United States
Children's Hospital of Philadelphia Children's Hospital Of Phil(2), Philadelphia, Pennsylvania, United States
Children s Hospital of Philadelphia Patient Treatment, Philadelphia, Pennsylvania, United States
Children s Hospital of Philadelphia, Philadelphia, Pennsylvania, United States
University of Pennsylvania, Philadelphia, Pennsylvania, United States
Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States
The Childrens Hospital of Philadelphia Children's Hosp Philadelphia, Philadelphia, Pennsylvania, United States
The Childrens Hospital of Philadelphia Pediatric Oncology/Stem Cell T, Philadelphia, Pennsylvania, United States
The Childrens Hospital of Philadelphia Regulatory, Philadelphia, Pennsylvania, United States
University of Pennsylvania Health System CERL080AUS90, Philadelphia, Pennsylvania, United States
Pennsylvania Oncology/Hemotology Dept.ofPenn. Onc./Hem., Philadelphia, Pennsylvania, United States
Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
University of Pittsburgh Cancer Institute, Pittsburgh, Pennsylvania, United States
Medical University of South Carolina MUSC, Charleston, South Carolina, United States
Prisma Health Cancer Institute, Greenville, South Carolina, United States
Avera McKennan Hospital and University Health Center, Sioux Falls, South Dakota, United States
Methodist University Hospital Blood and Marrow Transplant, Memphis, Tennessee, United States
Texas Cancer Center ( Medical City Dallas Hospital) TX Cancer Center, Dallas, Texas, United States
Univof Texas Southwestern Medical Center, Dept of Pediatrics, Dallas, Texas, United States
U of TX Southwestern Medical Center - SimmonsCompCancerCtr Satellite, Dallas, Texas, United States
UT Southwestern Medical Center Pediatric Hematology/Onc, Dallas, Texas, United States
UT Southwestern Medical Center UT SW Medical Ctr of Dallas, Dallas, Texas, United States
Cook Children's, Fort Worth, Texas, United States
Texas Children's Hospital Baylor College of Medicine, Houston, Texas, United States
Baylor College of Medicine, Houston, Texas, United States
Houston Methodist Cancer Center Methodist Cancer Center (2), Houston, Texas, United States
Houston Methodist Hospital, Houston, Texas, United States
MD Anderson Cancer Center/University of Texas MDACC, Houston, Texas, United States
MD Anderson Cancer Center/University of Texas StudyCoordinator:CTKI258A2102, Houston, Texas, United States
MD Anderson Cancer Center, Houston, Texas, United States
Methodist Hospital / Methodist Cancer Center Houston Methodist Hospital, Houston, Texas, United States
Methodist Healthcare System, San Antonio, Texas, United States
Methodist Hospital, San Antonio, Texas, United States
University of Utah / Huntsman Cancer Institute Huntsman Cancer Cente, Salt Lake City, Utah, United States
Primary Childrens Medical Center Oncology, Salt Lake City, Utah, United States
LDS Hospital, Salt Lake City, Utah, United States
University of Virginia Health Systems UVA, Charlottesville, Virginia, United States
VCU Health Systems, MCV, Richmond, Virginia, United States
Fred Hutchinson Cancer Research Center Dept. of FHCRC, Seattle, Washington, United States
University of Wisconsin Hospital and Clinics, Madison, Wisconsin, United States
University of Wisconsin Hospital and Clinics Hematopoietic Stem Cell Lab, Madison, Wisconsin, United States
University of Wisconsin Hospital and Clinics, Madison, Wisconsin, United States
University Wisconsin Children's Hospital, Madison, Wisconsin, United States
Childrens Hospital of Wisconsin, Milwaukee, Wisconsin, United States
Medical College of Wisconsin Med College of WI (29), Milwaukee, Wisconsin, United States
Novartis Investigative Site, Murdoch, Western Australia, Australia
Novartis Investigative Site, Toronto, Ontario, Canada
Novartis Investigative Site, Montreal, Quebec, Canada
Contact Details
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