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®)
Brief Summary

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.

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.

Available
Intermediate-size Population
Acute Lymphoblastic Leukemia (ALL)
Diffuse Large B-cell Lymphoma (DLBCL)

Biological: CTL019

CTL019
Other Name: tisagenlecleucel,Kymriah

Eligibility Criteria

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.

Eligibility Gender
All
Eligibility Age
Minimum: 1 Day ~ Maximum: 25 Years
Countries
Australia
Canada
United States
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

Contacts

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

Novartis Pharmaceuticals
NCT Number
Keywords
Acute Lymphoblastic Leukemia
ALL
Pediatric
Diffuse Large b-cell Lymphoma
DLBCL
Adult
Relapse
refractory
CTL019
tisagenlecleucel
Kymriah
CART19
CART
CAR T cells
Chimeric antigen receptor
Manufacturing
Expanded Access
Out of Specification
MeSH Terms
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Tisagenlecleucel