Managed Access Program (MAP) to provide access to CTL019, for acute lymphoblasticleukemia (ALL) or diffuse large b-cell lymphoma (DLBCL) patients with out ofspecification leukapheresis product and/or manufactured tisagenlecleucel out ofspecification for commercial release.
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.
Biological: CTL019
CTL019
Other Name: tisagenlecleucel,Kymriah
Inclusion Criteria:
Patients eligible for inclusion in this Treatment Plan have to meet all of the following
criteria:
1. Patients must be treated at a healthcare facility that has been certified /qualified
by Novartis to dispense and administer tisagenlecleucel in line with the
tisagenlecleucel Risk Evaluation and Mitigation Strategy (REMS) in the United States
(US) or the local Risk Management Plan (RMP).
- Note that tisagenlecleucel treatment should be initiated under the direction of
and supervised by a HCP experienced in the treatment of hematological malignancies
and trained for administration and management of patients treated with
tisagenlecleucel. The healthcare facility must have tocilizumab for use in the event
of cytokine release syndrome and emergency equipment per patient prior to infusion
on site and ensure timely access to additional doses of tocilizumab; for detailed
requirements refer to the approved local label.
2. Patients must be prescribed tisagenlecleucel in line with the locally approved
indications (for the precise indication statements see approved local product
label). These may include:
- pediatric and young adult patients up to and (including) 25 years of age with
refractory/relapsed (r/r) acute lymphoblastic leukemia (B-ALL)
- adult patients with r/r diffuse large B-cell lymphoma (DLBCL)
3. Informed consent must be obtained prior to treatment
4. The incoming apheresis material and/or the final manufactured product is out of
specification due to failure to meet acceptance or release specifications
Exclusion Criteria:
Patients eligible for this Treatment Plan must not meet any of the following criteria:
1. Contraindications as per the approved local label or the IB.
Banner MDACC
Gilbert 5295903, Arizona 5551752, United States
University of Arizona Cancer Center
Phoenix 5308655, Arizona 5551752, United States
Banner University of Arizona Medical Center
Phoenix 5308655, Arizona 5551752, United States
Phoenix Children's Hospital
Phoenix 5308655, Arizona 5551752, United States
Phoenix Childrens Hospital
Phoenix 5308655, Arizona 5551752, United States
Banner Uni Medical Center Tucson
Tucson 5318313, Arizona 5551752, United States
City of Hope National Medical Center Hematology&HematCellTransplant
Duarte 5344147, California 5332921, United States
City of Hope
Duarte 5344147, California 5332921, United States
Children's Hospital Los Angeles CRFB002H2301
Los Angeles 5368361, California 5332921, United States
Children's Hospital Los Angeles
Los Angeles 5368361, California 5332921, United States
Childrens Hospital Los Angeles
Los Angeles 5368361, California 5332921, United States
Mattel Childrens Hospital UCLA
Los Angeles 5368361, California 5332921, United States
University of California at Los Angeles UCLA
Los Angeles 5368361, California 5332921, United States
Lucile Packard Children s Hospital Stanford University
Palo Alto 5380748, California 5332921, United States
Lucile Packard Childrens Hospital
Palo Alto 5380748, California 5332921, United States
Stanford University Medical Center
Palo Alto 5380748, California 5332921, United States
UC San Diego
San Diego 5391811, California 5332921, United States
University of California at San Diego, Moores Cancer Ctr UCSD
San Diego 5391811, California 5332921, United States
Rady Children s Hospital Dept of Oncology
San Diego 5391811, California 5332921, United States
Rady Childrens Hospital
San Diego 5391811, California 5332921, United States
Ucsf Benioff Childrens Hospital Pediatric Hematology Oncology
San Francisco 5391959, California 5332921, United States
University of Califronia San Francisco
San Francisco 5391959, California 5332921, United States
University of California, Los Angeles
Santa Monica 5393212, California 5332921, United States
Stanford Healthcare
Stanford 5398563, California 5332921, United States
Children's Hospital Colorado
Denver 5419384, Colorado 5417618, United States
Yale Cancer Center
New Haven 4839366, Connecticut 4831725, United States
University of Miami Hospital
Miami 4164138, Florida 4155751, United States
JHMI All Children s Hospital
St. Petersburg 4171563, Florida 4155751, United States
Emory University School of Medicine Emory University (12)
Atlanta 4180439, Georgia 4197000, United States
Emory University School of Medicine/Winship Cancer Institute Winship Cancer Center
Atlanta 4180439, Georgia 4197000, United States
Emory University School of Medicine/Winship Cancer Institute
Atlanta 4180439, Georgia 4197000, United States
Children's Healthcare of Atlanta Cellular Therapies Lab
Atlanta 4180439, Georgia 4197000, United States
Northside Hospital
Atlanta 4180439, Georgia 4197000, United States
Ann and Robert H Lurie Childrens Hospital of Chicago
Chicago 4887398, Illinois 4896861, United States
Northwestern
Chicago 4887398, Illinois 4896861, United States
University of Illinois at Chicago
Chicago 4887398, Illinois 4896861, United States
University of CHicago Comer Children's Hospital Regulatory
Chicago 4887398, Illinois 4896861, United States
University of Chicago
Chicago 4887398, Illinois 4896861, United States
Healthwatch Plaza Research Associates
Louisville 4299276, Kentucky 6254925, United States
University of Maryland Medical Center UMMC
Baltimore 4347778, Maryland 4361885, United States
University of Maryland Medical Center
Baltimore 4347778, Maryland 4361885, United States
University of Maryland
Baltimore 4347778, Maryland 4361885, United States
Johns Hopkins Outpatient Center
Baltimore 4347778, Maryland 4361885, United States
Johns Hopkins University Hospital
Baltimore 4347778, Maryland 4361885, United States
Tufts Medical Center
Boston 4930956, Massachusetts 6254926, United States
Massachusetts General Hospital Cancer Center
Boston 4930956, Massachusetts 6254926, United States
Massachusetts General Hospital DF/HCC institutions
Boston 4930956, Massachusetts 6254926, United States
Massachusetts General Hospital
Boston 4930956, Massachusetts 6254926, United States
MGH Cancer Center MGH Cancer Center
Boston 4930956, Massachusetts 6254926, United States
MGH Cancer Center
Boston 4930956, Massachusetts 6254926, United States
Dana Farber Cancer Institute Dana Farber Cancer Institute
Boston 4930956, Massachusetts 6254926, United States
Dana Farber Cancer Institute
Boston 4930956, Massachusetts 6254926, United States
Dana-Farber Cancer Institute
Boston 4930956, Massachusetts 6254926, United States
University of Michigan IRB
Ann Arbor 4984247, Michigan 5001836, United States
University of Michigan Medical Center
Ann Arbor 4984247, Michigan 5001836, United States
University of Michigan Health System
Ann Arbor 4984247, Michigan 5001836, United States
Karmanos Cancer Institute
Detroit 4990729, Michigan 5001836, United States
Moffitt Cancer Center
Detroit 4990729, Michigan 5001836, United States
Wayne State University - Karmanos Cancer Institute
Detroit 4990729, Michigan 5001836, United States
Henry Ford Hospital Henry Ford
Detroit 4990729, Michigan 5001836, United States
University of Minnesota Masonic Childrens Hospital
Minneapolis 5037649, Minnesota 5037779, United States
University of Minnesota
Minneapolis 5037649, Minnesota 5037779, United States
Mayo CLinic
Rochester 5043473, Minnesota 5037779, United States
WUSTL Jewish Barnes
St Louis 4407066, Missouri 4398678, United States
Hackensack University Medical Center Hackensack UMC
Hackensack 5098706, New Jersey 5101760, United States
Hackensack University Medical Center Onc Dept
Hackensack 5098706, New Jersey 5101760, United States
Robert Wood Johnson Medical School
New Brunswick 5101717, New Jersey 5101760, United States
Rutgers Cancer Institute of New Jersey
New Brunswick 5101717, New Jersey 5101760, United States
Roswell Park Cancer Institute Rosewell
Buffalo 5110629, New York 5128638, United States
Roswell Park Cancer Institute
Buffalo 5110629, New York 5128638, United States
Memorial Sloan Kettering
New York 5128581, New York 5128638, United States
Memorial Sloan Kettering Cancer Center MSKCC
New York 5128581, New York 5128638, United States
Memorial Sloan Kettering Cancer Center Oncology
New York 5128581, New York 5128638, United States
Columbia University Medical Center New York Presbyterian CUMC Research Pharmacy
New York 5128581, New York 5128638, United States
Columbia University Medical Center New York Presbyterian Neuroendocrine Unit
New York 5128581, New York 5128638, United States
Memorial Sloan Kettering Cancer Center MSKCC (9)
New York 5128581, New York 5128638, United States
Memorial Sloan Kettering Cancer Center
New York 5128581, New York 5128638, United States
University of North Carolina Chapel Hill Physician Office Building
Chapel Hill 4460162, North Carolina 4482348, United States
University of North Carolina Health System
Chapel Hill 4460162, North Carolina 4482348, United States
Atrium Heath
Charlotte 4460243, North Carolina 4482348, United States
Duke University Medical Center Dept. of DUMC (4)
Durham 4464368, North Carolina 4482348, United States
Duke University Medical Center
Durham 4464368, North Carolina 4482348, United States
Cincinnati Children s Hospital Medical Center
Cincinnati 4508722, Ohio 5165418, United States
Cincinnati Childrens Hospital
Cincinnati 4508722, Ohio 5165418, United States
Oncology Hematology Care Inc Drug Shipment
Cincinnati 4508722, Ohio 5165418, United States
University Hospitals Cleveland Medical Center Univ. Hospitals of Cleveland
Cleveland 5150529, Ohio 5165418, United States
Nationwide Childrens Hospital Center
Columbus 4509177, Ohio 5165418, United States
OSU Wexner MC James CH
Columbus 4509177, Ohio 5165418, United States
The Ohio State University Hospitals Clinic The Ohio State University
Columbus 4509177, Ohio 5165418, United States
The Ohio State University Hospitals Clinic
Columbus 4509177, Ohio 5165418, United States
The Ohio State University Regulatory
Columbus 4509177, Ohio 5165418, United States
The Ohio State University Comprehensive Cancer Center Ohio State UMC James Cancer Ct
Columbus 4509177, Ohio 5165418, United States
Hematology Oncology Center, Inc.
Elyria 5153207, Ohio 5165418, United States
Oregon Health Sciences University
Portland 5746545, Oregon 5744337, United States
Oregon Health and Science University
Portland 5746545, Oregon 5744337, United States
OHSU
Portland 5746545, Oregon 5744337, United States
Oregon Health and Science University
Portland 5746545, Oregon 5744337, United States
Childrens Hospital of Philadelphia CTRB 3006
Philadelphia 4560349, Pennsylvania 6254927, United States
Hospital of the University of Pennsylvania
Philadelphia 4560349, Pennsylvania 6254927, United States
Children's Hospital of Philadelphia Children's Hospital Of Phil(2)
Philadelphia 4560349, Pennsylvania 6254927, United States
Children s Hospital of Philadelphia Patient Treatment
Philadelphia 4560349, Pennsylvania 6254927, United States
Children s Hospital of Philadelphia
Philadelphia 4560349, Pennsylvania 6254927, United States
University of Pennsylvania
Philadelphia 4560349, Pennsylvania 6254927, United States
Children's Hospital of Philadelphia
Philadelphia 4560349, Pennsylvania 6254927, United States
The Childrens Hospital of Philadelphia Children's Hosp Philadelphia
Philadelphia 4560349, Pennsylvania 6254927, United States
The Childrens Hospital of Philadelphia Pediatric Oncology/Stem Cell T
Philadelphia 4560349, Pennsylvania 6254927, United States
The Childrens Hospital of Philadelphia Regulatory
Philadelphia 4560349, Pennsylvania 6254927, United States
University of Pennsylvania Health System CERL080AUS90
Philadelphia 4560349, Pennsylvania 6254927, United States
Pennsylvania Oncology/Hemotology Dept.ofPenn. Onc./Hem.
Philadelphia 4560349, Pennsylvania 6254927, United States
Thomas Jefferson University Hospital
Philadelphia 4560349, Pennsylvania 6254927, United States
Fox Chase Cancer Center
Philadelphia 4560349, Pennsylvania 6254927, United States
University of Pittsburgh Cancer Institute
Pittsburgh 5206379, Pennsylvania 6254927, United States
Medical University of South Carolina MUSC
Charleston 4574324, South Carolina 4597040, United States
Prisma Health Cancer Institute
Greenville 4580543, South Carolina 4597040, United States
Avera McKennan Hospital and University Health Center
Sioux Falls 5231851, South Dakota 5769223, United States
Methodist University Hospital Blood and Marrow Transplant
Memphis 4641239, Tennessee 4662168, United States
Texas Cancer Center ( Medical City Dallas Hospital) TX Cancer Center
Dallas 4684888, Texas 4736286, United States
Univof Texas Southwestern Medical Center, Dept of Pediatrics
Dallas 4684888, Texas 4736286, United States
U of TX Southwestern Medical Center - SimmonsCompCancerCtr Satellite
Dallas 4684888, Texas 4736286, United States
UT Southwestern Medical Center Pediatric Hematology/Onc
Dallas 4684888, Texas 4736286, United States
UT Southwestern Medical Center UT SW Medical Ctr of Dallas
Dallas 4684888, Texas 4736286, United States
Cook Children's
Fort Worth 4691930, Texas 4736286, United States
Texas Children's Hospital Baylor College of Medicine
Houston 4699066, Texas 4736286, United States
Baylor College of Medicine
Houston 4699066, Texas 4736286, United States
Houston Methodist Cancer Center Methodist Cancer Center (2)
Houston 4699066, Texas 4736286, United States
Houston Methodist Hospital
Houston 4699066, Texas 4736286, United States
MD Anderson Cancer Center/University of Texas MDACC
Houston 4699066, Texas 4736286, United States
MD Anderson Cancer Center/University of Texas StudyCoordinator:CTKI258A2102
Houston 4699066, Texas 4736286, United States
MD Anderson Cancer Center
Houston 4699066, Texas 4736286, United States
Methodist Hospital / Methodist Cancer Center Houston Methodist Hospital
Houston 4699066, Texas 4736286, United States
Methodist Healthcare System
San Antonio 4726206, Texas 4736286, United States
Methodist Hospital
San Antonio 4726206, Texas 4736286, United States
University of Utah / Huntsman Cancer Institute Huntsman Cancer Cente
Salt Lake City 5780993, Utah 5549030, United States
Primary Childrens Medical Center Oncology
Salt Lake City 5780993, Utah 5549030, United States
LDS Hospital
Salt Lake City 5780993, Utah 5549030, United States
University of Virginia Health Systems UVA
Charlottesville 4752031, Virginia 6254928, United States
VCU Health Systems, MCV
Richmond 4781708, Virginia 6254928, United States
Fred Hutchinson Cancer Research Center Dept. of FHCRC
Seattle 5809844, Washington 5815135, United States
University of Wisconsin Hospital and Clinics
Madison 5261457, Wisconsin 5279468, United States
University of Wisconsin Hospital and Clinics Hematopoietic Stem Cell Lab
Madison 5261457, Wisconsin 5279468, United States
University of Wisconsin Hospital and Clinics
Madison 5261457, Wisconsin 5279468, United States
University Wisconsin Children's Hospital
Madison 5261457, Wisconsin 5279468, United States
Childrens Hospital of Wisconsin
Milwaukee 5263045, Wisconsin 5279468, United States
Medical College of Wisconsin Med College of WI (29)
Milwaukee 5263045, Wisconsin 5279468, United States
Novartis Investigative Site
Murdoch 8349091, Western Australia 2058645, Australia
Novartis Investigative Site
Toronto 6167865, Ontario 6093943, Canada
Novartis Investigative Site
Montreal 6077243, Quebec 6115047, Canada
MAP requests are initiated by a licensed physician.https:// www.novart is.com/healthcare-professionals/managed-access-programs
1-888-669-6682
novartis.email@novartis.com
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