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, 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
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
Novartis Pharmaceuticals
+41613241111