NCT03601442

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 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.

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Interventions

CTL019BIOLOGICAL
CTL019

Study Locations

FacilityCityStateCountry
Banner MDACCGilbertArizonaUnited States
University of Arizona Cancer CenterPhoenixArizonaUnited States
Banner University of Arizona Medical CenterPhoenixArizonaUnited States
Phoenix Children's HospitalPhoenixArizonaUnited States
Phoenix Childrens HospitalPhoenixArizonaUnited States
Banner Uni Medical Center TucsonTucsonArizonaUnited States
City of Hope National Medical Center Hematology&HematCellTransplantDuarteCaliforniaUnited States
City of HopeDuarteCaliforniaUnited States
Children's Hospital Los Angeles CRFB002H2301Los AngelesCaliforniaUnited States
Children's Hospital Los AngelesLos AngelesCaliforniaUnited States
Childrens Hospital Los AngelesLos AngelesCaliforniaUnited States
Mattel Childrens Hospital UCLALos AngelesCaliforniaUnited States
University of California at Los Angeles UCLALos AngelesCaliforniaUnited States
Lucile Packard Children s Hospital Stanford UniversityPalo AltoCaliforniaUnited States
Lucile Packard Childrens HospitalPalo AltoCaliforniaUnited States
Stanford University Medical CenterPalo AltoCaliforniaUnited States
UC San DiegoSan DiegoCaliforniaUnited States
University of California at San Diego, Moores Cancer Ctr UCSDSan DiegoCaliforniaUnited States
Rady Children s Hospital Dept of OncologySan DiegoCaliforniaUnited States
Rady Childrens HospitalSan DiegoCaliforniaUnited States
Ucsf Benioff Childrens Hospital Pediatric Hematology OncologySan FranciscoCaliforniaUnited States
University of Califronia San FranciscoSan FranciscoCaliforniaUnited States
University of California, Los AngelesSanta MonicaCaliforniaUnited States
Stanford HealthcareStanfordCaliforniaUnited States
Children's Hospital ColoradoDenverColoradoUnited States
Yale Cancer CenterNew HavenConnecticutUnited States
University of Miami HospitalMiamiFloridaUnited States
JHMI All Children s HospitalSt. PetersburgFloridaUnited States
Emory University School of Medicine Emory University (12)AtlantaGeorgiaUnited States
Emory University School of Medicine/Winship Cancer Institute Winship Cancer CenterAtlantaGeorgiaUnited States
Emory University School of Medicine/Winship Cancer InstituteAtlantaGeorgiaUnited States
Children's Healthcare of Atlanta Cellular Therapies LabAtlantaGeorgiaUnited States
Northside HospitalAtlantaGeorgiaUnited States
Ann and Robert H Lurie Childrens Hospital of ChicagoChicagoIllinoisUnited States
NorthwesternChicagoIllinoisUnited States
University of Illinois at ChicagoChicagoIllinoisUnited States
University of CHicago Comer Children's Hospital RegulatoryChicagoIllinoisUnited States
University of ChicagoChicagoIllinoisUnited States
Healthwatch Plaza Research AssociatesLouisvilleKentuckyUnited States
University of Maryland Medical Center UMMCBaltimoreMarylandUnited States
University of Maryland Medical CenterBaltimoreMarylandUnited States
University of MarylandBaltimoreMarylandUnited States
Johns Hopkins Outpatient CenterBaltimoreMarylandUnited States
Johns Hopkins University HospitalBaltimoreMarylandUnited States
Tufts Medical CenterBostonMassachusettsUnited States
Massachusetts General Hospital Cancer CenterBostonMassachusettsUnited States
Massachusetts General Hospital DF/HCC institutionsBostonMassachusettsUnited States
Massachusetts General HospitalBostonMassachusettsUnited States
MGH Cancer Center MGH Cancer CenterBostonMassachusettsUnited States
MGH Cancer CenterBostonMassachusettsUnited States
Dana Farber Cancer Institute Dana Farber Cancer InstituteBostonMassachusettsUnited States
Dana Farber Cancer InstituteBostonMassachusettsUnited States
Dana-Farber Cancer InstituteBostonMassachusettsUnited States
University of Michigan IRBAnn ArborMichiganUnited States
University of Michigan Medical CenterAnn ArborMichiganUnited States
University of Michigan Health SystemAnn ArborMichiganUnited States
Karmanos Cancer InstituteDetroitMichiganUnited States
Moffitt Cancer CenterDetroitMichiganUnited States
Wayne State University - Karmanos Cancer InstituteDetroitMichiganUnited States
Henry Ford Hospital Henry FordDetroitMichiganUnited States
University of Minnesota Masonic Childrens HospitalMinneapolisMinnesotaUnited States
University of MinnesotaMinneapolisMinnesotaUnited States
Mayo CLinicRochesterMinnesotaUnited States
WUSTL Jewish BarnesSt LouisMissouriUnited States
Hackensack University Medical Center Hackensack UMCHackensackNew JerseyUnited States
Hackensack University Medical Center Onc DeptHackensackNew JerseyUnited States
Robert Wood Johnson Medical SchoolNew BrunswickNew JerseyUnited States
Rutgers Cancer Institute of New JerseyNew BrunswickNew JerseyUnited States
Roswell Park Cancer Institute RosewellBuffaloNew YorkUnited States
Roswell Park Cancer InstituteBuffaloNew YorkUnited States
Memorial Sloan KetteringNew YorkNew YorkUnited States
Memorial Sloan Kettering Cancer Center MSKCCNew YorkNew YorkUnited States
Memorial Sloan Kettering Cancer Center OncologyNew YorkNew YorkUnited States
Columbia University Medical Center New York Presbyterian CUMC Research PharmacyNew YorkNew YorkUnited States
Columbia University Medical Center New York Presbyterian Neuroendocrine UnitNew YorkNew YorkUnited States
Memorial Sloan Kettering Cancer Center MSKCC (9)New YorkNew YorkUnited States
Memorial Sloan Kettering Cancer CenterNew YorkNew YorkUnited States
University of North Carolina Chapel Hill Physician Office BuildingChapel HillNorth CarolinaUnited States
University of North Carolina Health SystemChapel HillNorth CarolinaUnited States
Atrium HeathCharlotteNorth CarolinaUnited States
Duke University Medical Center Dept. of DUMC (4)DurhamNorth CarolinaUnited States
Duke University Medical CenterDurhamNorth CarolinaUnited States
Cincinnati Children s Hospital Medical CenterCincinnatiOhioUnited States
Cincinnati Childrens HospitalCincinnatiOhioUnited States
Oncology Hematology Care Inc Drug ShipmentCincinnatiOhioUnited States
University Hospitals Cleveland Medical Center Univ. Hospitals of ClevelandClevelandOhioUnited States
Nationwide Childrens Hospital CenterColumbusOhioUnited States
OSU Wexner MC James CHColumbusOhioUnited States
The Ohio State University Hospitals Clinic The Ohio State UniversityColumbusOhioUnited States
The Ohio State University Hospitals ClinicColumbusOhioUnited States
The Ohio State University RegulatoryColumbusOhioUnited States
The Ohio State University Comprehensive Cancer Center Ohio State UMC James Cancer CtColumbusOhioUnited States
Hematology Oncology Center, Inc.ElyriaOhioUnited States
Oregon Health Sciences UniversityPortlandOregonUnited States
Oregon Health and Science UniversityPortlandOregonUnited States
OHSUPortlandOregonUnited States
Oregon Health and Science UniversityPortlandOregonUnited States
Childrens Hospital of Philadelphia CTRB 3006PhiladelphiaPennsylvaniaUnited States
Hospital of the University of PennsylvaniaPhiladelphiaPennsylvaniaUnited States
Children's Hospital of Philadelphia Children's Hospital Of Phil(2)PhiladelphiaPennsylvaniaUnited States
Children s Hospital of Philadelphia Patient TreatmentPhiladelphiaPennsylvaniaUnited States
Children s Hospital of PhiladelphiaPhiladelphiaPennsylvaniaUnited States
University of PennsylvaniaPhiladelphiaPennsylvaniaUnited States
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvaniaUnited States
The Childrens Hospital of Philadelphia Children's Hosp PhiladelphiaPhiladelphiaPennsylvaniaUnited States
The Childrens Hospital of Philadelphia Pediatric Oncology/Stem Cell TPhiladelphiaPennsylvaniaUnited States
The Childrens Hospital of Philadelphia RegulatoryPhiladelphiaPennsylvaniaUnited States
University of Pennsylvania Health System CERL080AUS90PhiladelphiaPennsylvaniaUnited States
Pennsylvania Oncology/Hemotology Dept.ofPenn. Onc./Hem.PhiladelphiaPennsylvaniaUnited States
Thomas Jefferson University HospitalPhiladelphiaPennsylvaniaUnited States
Fox Chase Cancer CenterPhiladelphiaPennsylvaniaUnited States
University of Pittsburgh Cancer InstitutePittsburghPennsylvaniaUnited States
Medical University of South Carolina MUSCCharlestonSouth CarolinaUnited States
Prisma Health Cancer InstituteGreenvilleSouth CarolinaUnited States
Avera McKennan Hospital and University Health CenterSioux FallsSouth DakotaUnited States
Methodist University Hospital Blood and Marrow TransplantMemphisTennesseeUnited States
Texas Cancer Center ( Medical City Dallas Hospital) TX Cancer CenterDallasTexasUnited States
Univof Texas Southwestern Medical Center, Dept of PediatricsDallasTexasUnited States
U of TX Southwestern Medical Center - SimmonsCompCancerCtr SatelliteDallasTexasUnited States
UT Southwestern Medical Center Pediatric Hematology/OncDallasTexasUnited States
UT Southwestern Medical Center UT SW Medical Ctr of DallasDallasTexasUnited States
Cook Children'sFort WorthTexasUnited States
Texas Children's Hospital Baylor College of MedicineHoustonTexasUnited States
Baylor College of MedicineHoustonTexasUnited States
Houston Methodist Cancer Center Methodist Cancer Center (2)HoustonTexasUnited States
Houston Methodist HospitalHoustonTexasUnited States
MD Anderson Cancer Center/University of Texas MDACCHoustonTexasUnited States
MD Anderson Cancer Center/University of Texas StudyCoordinator:CTKI258A2102HoustonTexasUnited States
MD Anderson Cancer CenterHoustonTexasUnited States
Methodist Hospital / Methodist Cancer Center Houston Methodist HospitalHoustonTexasUnited States
Methodist Healthcare SystemSan AntonioTexasUnited States
Methodist HospitalSan AntonioTexasUnited States
University of Utah / Huntsman Cancer Institute Huntsman Cancer CenteSalt Lake CityUtahUnited States
Primary Childrens Medical Center OncologySalt Lake CityUtahUnited States
LDS HospitalSalt Lake CityUtahUnited States
University of Virginia Health Systems UVACharlottesvilleVirginiaUnited States
VCU Health Systems, MCVRichmondVirginiaUnited States
Fred Hutchinson Cancer Research Center Dept. of FHCRCSeattleWashingtonUnited States
University of Wisconsin Hospital and ClinicsMadisonWisconsinUnited States
University of Wisconsin Hospital and Clinics Hematopoietic Stem Cell LabMadisonWisconsinUnited States
University of Wisconsin Hospital and ClinicsMadisonWisconsinUnited States
University Wisconsin Children's HospitalMadisonWisconsinUnited States
Childrens Hospital of WisconsinMilwaukeeWisconsinUnited States
Medical College of Wisconsin Med College of WI (29)MilwaukeeWisconsinUnited States
Novartis Investigative SiteMurdochWestern AustraliaAustralia
Novartis Investigative SiteTorontoOntarioCanada
Novartis Investigative SiteMontrealQuebecCanada

Official Trial Information

View on ClinicalTrials.gov

Data sourced from ClinicalTrials.gov. Last updated: April 14, 2026