Managed Access Programs for CTL019, Tisagenlecleucel

April 20, 2026 updated by: Novartis Pharmaceuticals
The purpose of this registration is to list Managed Access Programs (MAPs) related to CTL019, Tisagenlecleucel

Study Overview

Status

Available

Conditions

Intervention / Treatment

Detailed Description

CCTL019B2003I - Available - Managed Access Program (MAP) to provide access to patients with out-of-specification (OOS) leukapheresis product and/or OOS manufactured CTL019

CCTL019B2004I - Available - Managed Access Program (MAP) to provide access to reinfusion for approved indications

CCTL019A02001I - Available - Managed Access Program (MAP) to provide access to CLT019 in off-label indications

Study Type

Expanded Access

Expanded Access Type

  • Individual Patients
  • Intermediate-size Population

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Western Australia
      • Murdoch, Western Australia, Australia, 6150
        • Available
        • Novartis Investigative Site
  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 1X8
        • Available
        • Novartis Investigative Site
    • Quebec
      • Montreal, Quebec, Canada, H1T 2M4
        • Available
        • Novartis Investigative Site
  • United States
    • Arizona
      • Gilbert, Arizona, United States, 85234
        • Available
        • Banner MDACC
      • Phoenix, Arizona, United States, 85016
        • Available
        • Phoenix Children's Hospital
      • Phoenix, Arizona, United States, 85004
        • Available
        • University of Arizona Cancer Center
      • Phoenix, Arizona, United States, 85006
        • Available
        • Banner University of Arizona Medical Center
      • Phoenix, Arizona, United States, 85016
        • Available
        • Phoenix Childrens Hospital
      • Tucson, Arizona, United States, 85724
        • Available
        • Banner Uni Medical Center Tucson
    • California
      • Duarte, California, United States, 91010 3000
        • Available
        • City of Hope National Medical Center Hematology&HematCellTransplant
      • Duarte, California, United States, 91010
        • Available
        • City Of Hope
      • Los Angeles, California, United States, 90027
        • Available
        • Children's Hospital Los Angeles CRFB002H2301
      • Los Angeles, California, United States, 90027
        • Available
        • Children's Hospital Los Angeles
      • Los Angeles, California, United States, 90027
        • Available
        • Childrens Hospital Los Angeles
      • Los Angeles, California, United States, 90095
        • Available
        • Mattel Childrens Hospital UCLA
      • Los Angeles, California, United States, 90095
        • Available
        • University of California at Los Angeles UCLA
      • Palo Alto, California, United States, 94304
        • Available
        • Lucile Packard Children s Hospital Stanford University
      • Palo Alto, California, United States, 94304
        • Available
        • Lucile Packard Childrens Hospital
      • Palo Alto, California, United States, 94304
        • Available
        • Stanford University Medical Center
      • San Diego, California, United States, 92093-0979
        • Available
        • UC San Diego
      • San Diego, California, United States, 92103
        • Available
        • University of California at San Diego, Moores Cancer Ctr UCSD
      • San Diego, California, United States, 92123
        • Available
        • Rady Children s Hospital Dept of Oncology
      • San Diego, California, United States, 92123
        • Available
        • Rady Childrens Hospital
      • San Francisco, California, United States, 94143
        • Available
        • Ucsf Benioff Childrens Hospital Pediatric Hematology Oncology
      • San Francisco, California, United States, 94143
        • Available
        • University of Califronia San Francisco
      • Santa Monica, California, United States, 90904
        • Available
        • University of California, Los Angeles
      • Stanford, California, United States, 94304
        • Available
        • Stanford Healthcare
    • Colorado
      • Denver, Colorado, United States, 80218
        • Available
        • Children's Hospital Colorado
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Available
        • Yale Cancer Center
    • Florida
      • Miami, Florida, United States, 33136
        • Available
        • University of Miami Hospital
      • St. Petersburg, Florida, United States, 33701
        • Available
        • JHMI All Children s Hospital
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Available
        • Northside Hospital
      • Atlanta, Georgia, United States, 30322
        • Available
        • Emory University School of Medicine Emory University (12)
      • Atlanta, Georgia, United States, 30322
        • Available
        • Emory University School of Medicine/Winship Cancer Institute Winship Cancer Center
      • Atlanta, Georgia, United States, 30322
        • Available
        • Emory University School of Medicine/Winship Cancer Institute
      • Atlanta, Georgia, United States, 30342
        • Available
        • Children's Healthcare of Atlanta Cellular Therapies Lab
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Available
        • University of Chicago
      • Chicago, Illinois, United States, 60611
        • Available
        • Ann and Robert H Lurie Childrens Hospital of Chicago
      • Chicago, Illinois, United States, 60611
        • Available
        • Northwestern
      • Chicago, Illinois, United States, 60612
        • Available
        • University of Illinois at Chicago
      • Chicago, Illinois, United States, 60637-1470
        • Available
        • University of CHicago Comer Children's Hospital Regulatory
    • Kentucky
      • Louisville, Kentucky, United States, 40217
        • Available
        • Healthwatch Plaza Research Associates
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Available
        • University of Maryland Medical Center
      • Baltimore, Maryland, United States, 21201
        • Available
        • University of Maryland Medical Center UMMC
      • Baltimore, Maryland, United States, 21201
        • Available
        • University of Maryland
      • Baltimore, Maryland, United States, 21287
        • Available
        • Johns Hopkins Outpatient Center
      • Baltimore, Maryland, United States, 21287
        • Available
        • Johns Hopkins University Hospital
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Available
        • Massachusetts General Hospital
      • Boston, Massachusetts, United States, 02215
        • Available
        • Dana-Farber Cancer Institute
      • Boston, Massachusetts, United States, 02215
        • Available
        • Dana Farber Cancer Institute
      • Boston, Massachusetts, United States, 02111
        • Available
        • Tufts Medical Center
      • Boston, Massachusetts, United States, 02114
        • Available
        • Massachusetts General Hospital Cancer Center
      • Boston, Massachusetts, United States, 02114
        • Available
        • Massachusetts General Hospital DF/HCC institutions
      • Boston, Massachusetts, United States, 02114
        • Available
        • MGH Cancer Center MGH Cancer Center
      • Boston, Massachusetts, United States, 02114
        • Available
        • MGH Cancer Center
      • Boston, Massachusetts, United States, 02215
        • Available
        • Dana Farber Cancer Institute Dana Farber Cancer Institute
    • Michigan
      • Ann Arbor, Michigan, United States, 48109-2800
        • Available
        • University of Michigan IRB
      • Ann Arbor, Michigan, United States, 48109-5848
        • Available
        • University of Michigan Medical Center
      • Ann Arbor, Michigan, United States, 48109
        • Available
        • University of Michigan Health System
      • Detroit, Michigan, United States, 48201
        • Available
        • Karmanos Cancer Institute
      • Detroit, Michigan, United States, 48201
        • Available
        • Moffitt Cancer Center
      • Detroit, Michigan, United States, 48201
        • Available
        • Wayne State University - Karmanos Cancer Institute
      • Detroit, Michigan, United States, 48202 2689
        • Available
        • Henry Ford Hospital Henry Ford
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Available
        • University of Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Available
        • University of Minnesota Masonic Childrens Hospital
      • Rochester, Minnesota, United States, 55905
        • Available
        • Mayo Clinic
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Available
        • WUSTL Jewish Barnes
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Available
        • Hackensack University Medical Center Hackensack UMC
      • Hackensack, New Jersey, United States, 07601
        • Available
        • Hackensack University Medical Center Onc Dept
      • New Brunswick, New Jersey, United States, 08901
        • Available
        • Robert Wood Johnson Medical School
      • New Brunswick, New Jersey, United States, 08903
        • Available
        • Rutgers Cancer Institute of New Jersey
    • New York
      • Buffalo, New York, United States, 14263
        • Available
        • Roswell Park Cancer Institute Rosewell
      • Buffalo, New York, United States, 14263
        • Available
        • Roswell Park Cancer Institute
      • New York, New York, United States, 10065
        • Available
        • Memorial Sloan Kettering Cancer Center
      • New York, New York, United States, 10017
        • Available
        • Memorial Sloan Kettering
      • New York, New York, United States, 10021
        • Available
        • Memorial Sloan Kettering Cancer Center Mskcc
      • New York, New York, United States, 10021
        • Available
        • Memorial Sloan Kettering Cancer Center Oncology
      • New York, New York, United States, 10032
        • Available
        • Columbia University Medical Center New York Presbyterian CUMC Research Pharmacy
      • New York, New York, United States, 10032
        • Available
        • Columbia University Medical Center New York Presbyterian Neuroendocrine Unit
      • New York, New York, United States, 10065
        • Available
        • Memorial Sloan Kettering Cancer Center MSKCC (9)
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • Available
        • University of North Carolina Chapel Hill Physician Office Building
      • Chapel Hill, North Carolina, United States, 27599
        • Available
        • University of North Carolina Health System
      • Charlotte, North Carolina, United States, 28203
        • Available
        • Atrium Heath
      • Durham, North Carolina, United States, 27710
        • Available
        • Duke University Medical Center
      • Durham, North Carolina, United States, 27710
        • Available
        • Duke University Medical Center Dept. of DUMC (4)
    • Ohio
      • Cincinnati, Ohio, United States, 45229-3039
        • Available
        • Cincinnati Children s Hospital Medical Center
      • Cincinnati, Ohio, United States, 45229
        • Available
        • Cincinnati Childrens Hospital
      • Cincinnati, Ohio, United States, 45242
        • Available
        • Oncology Hematology Care Inc Drug Shipment
      • Cleveland, Ohio, United States, 44106-5028
        • Available
        • University Hospitals Cleveland Medical Center Univ. Hospitals of Cleveland
      • Columbus, Ohio, United States, 43205
        • Available
        • Nationwide Childrens Hospital Center
      • Columbus, Ohio, United States, 43210
        • Available
        • OSU Wexner MC James CH
      • Columbus, Ohio, United States, 43210
        • Available
        • The Ohio State University Hospitals Clinic The Ohio State University
      • Columbus, Ohio, United States, 43210
        • Available
        • The Ohio State University Hospitals Clinic
      • Columbus, Ohio, United States, 43210
        • Available
        • The Ohio State University Regulatory
      • Columbus, Ohio, United States, 43221
        • Available
        • The Ohio State University Comprehensive Cancer Center Ohio State UMC James Cancer Ct
      • Elyria, Ohio, United States, 44035
        • Available
        • Hematology Oncology Center, Inc.
    • Oregon
      • Portland, Oregon, United States, 97201
        • Available
        • Oregon Health Sciences University
      • Portland, Oregon, United States, 97239-3098
        • Available
        • Oregon Health and Science University
      • Portland, Oregon, United States, 97239
        • Available
        • OHSU
      • Portland, Oregon, United States, 97239
        • Available
        • Oregon Health and Science University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111
        • Available
        • Fox Chase Cancer Center
      • Philadelphia, Pennsylvania, United States, 19104
        • Available
        • Children's Hospital of Philadelphia
      • Philadelphia, Pennsylvania, United States, 19104 4399
        • Available
        • Childrens Hospital of Philadelphia CTRB 3006
      • Philadelphia, Pennsylvania, United States, 19104-4283
        • Available
        • Hospital of the University of Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104-4318
        • Available
        • Children's Hospital of Philadelphia Children's Hospital Of Phil(2)
      • Philadelphia, Pennsylvania, United States, 19104-4399
        • Available
        • Children s Hospital of Philadelphia Patient Treatment
      • Philadelphia, Pennsylvania, United States, 19104-4399
        • Available
        • Children s Hospital of Philadelphia
      • Philadelphia, Pennsylvania, United States, 19104-6149
        • Available
        • University of Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Available
        • The Childrens Hospital of Philadelphia Children's Hosp Philadelphia
      • Philadelphia, Pennsylvania, United States, 19104
        • Available
        • The Childrens Hospital of Philadelphia Pediatric Oncology/Stem Cell T
      • Philadelphia, Pennsylvania, United States, 19104
        • Available
        • The Childrens Hospital of Philadelphia Regulatory
      • Philadelphia, Pennsylvania, United States, 19104
        • Available
        • University of Pennsylvania Health System CERL080AUS90
      • Philadelphia, Pennsylvania, United States, 19106
        • Available
        • Pennsylvania Oncology/Hemotology Dept.ofPenn. Onc./Hem.
      • Philadelphia, Pennsylvania, United States, 19107
        • Available
        • Thomas Jefferson University Hospital
      • Pittsburgh, Pennsylvania, United States, 15232
        • Available
        • University of Pittsburgh Cancer Institute
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Available
        • Medical University of South Carolina MUSC
      • Greenville, South Carolina, United States, 29601
        • Available
        • Prisma Health Cancer Institute
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • Available
        • Avera McKennan Hospital and University Health Center
    • Tennessee
      • Memphis, Tennessee, United States, 38104
        • Available
        • Methodist University Hospital Blood and Marrow Transplant
    • Texas
      • Dallas, Texas, United States, 75230
        • Available
        • Texas Cancer Center ( Medical City Dallas Hospital) TX Cancer Center
      • Dallas, Texas, United States, 75235
        • Available
        • Univof Texas Southwestern Medical Center, Dept of Pediatrics
      • Dallas, Texas, United States, 75390
        • Available
        • U of TX Southwestern Medical Center - SimmonsCompCancerCtr Satellite
      • Dallas, Texas, United States, 75390
        • Available
        • UT Southwestern Medical Center Pediatric Hematology/Onc
      • Dallas, Texas, United States, 75390
        • Available
        • UT Southwestern Medical Center UT SW Medical Ctr of Dallas
      • Fort Worth, Texas, United States, 76104
        • Available
        • Cook Children's
      • Houston, Texas, United States, 77030
        • Available
        • MD Anderson Cancer Center
      • Houston, Texas, United States, 77030
        • Available
        • Baylor College of Medicine
      • Houston, Texas, United States, 77030-2399
        • Available
        • Texas Children's Hospital Baylor College of Medicine
      • Houston, Texas, United States, 77030
        • Available
        • Houston Methodist Cancer Center Methodist Cancer Center (2)
      • Houston, Texas, United States, 77030
        • Available
        • Houston Methodist Hospital
      • Houston, Texas, United States, 77030
        • Available
        • MD Anderson Cancer Center/University of Texas MDACC
      • Houston, Texas, United States, 77030
        • Available
        • MD Anderson Cancer Center/University of Texas StudyCoordinator:CTKI258A2102
      • Houston, Texas, United States, 77030
        • Available
        • Methodist Hospital / Methodist Cancer Center Houston Methodist Hospital
      • San Antonio, Texas, United States, 78229
        • Available
        • Methodist Healthcare System
      • San Antonio, Texas, United States, 78229
        • Available
        • Methodist Hospital
    • Utah
      • Salt Lake City, Utah, United States, 84103
        • Available
        • University of Utah / Huntsman Cancer Institute Huntsman Cancer Cente
      • Salt Lake City, Utah, United States, 84113
        • Available
        • Primary Childrens Medical Center Oncology
      • Salt Lake City, Utah, United States, 84132
        • Available
        • LDS Hospital
    • Virginia
      • Charlottesville, Virginia, United States, 22908-0334
        • Available
        • University of Virginia Health Systems UVA
      • Richmond, Virginia, United States, 23298
        • Available
        • VCU Health Systems, MCV
    • Washington
      • Seattle, Washington, United States, 98109
        • Available
        • Fred Hutchinson Cancer Research Center Dept. of FHCRC
    • Wisconsin
      • Madison, Wisconsin, United States, 53705-3611
        • Available
        • University of Wisconsin Hospital and Clinics
      • Madison, Wisconsin, United States, 53792
        • Available
        • University of Wisconsin Hospital and Clinics Hematopoietic Stem Cell Lab
      • Madison, Wisconsin, United States, 53792
        • Available
        • University of Wisconsin Hospital and Clinics
      • Madison, Wisconsin, United States, 53792
        • Available
        • University Wisconsin Children's Hospital
      • Milwaukee, Wisconsin, United States, 53226
        • Available
        • Childrens Hospital of Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Available
        • Medical College of Wisconsin Med College of WI (29)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 25 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

An independent request was received from a licensed physician. The patient has a serious or life-threatening disease or condition and there is no comparable or satisfactory alternative therapy available for diagnosis, monitoring, or treatment.

The patient is not eligible or able to enrol in a clinical trial or continue participation in such trial.

There is a potential patient benefit to justify the potential risk of the treatment use, and the potential risk is not unreasonable in the context of the disease or condition to be treated.

The patient must meet any other medical criteria established by the medical experts responsible for the product or by the health authority in the country of request (as applicable).

Provision of the product will not interfere with the initiation, conduct, or completion of a Novartis clinical trial or overall development program.

Managed Access provision is allowed per local laws/regulations.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Investigators

  • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

July 16, 2018

First Submitted That Met QC Criteria

July 16, 2018

First Posted (Actual)

July 26, 2018

Study Record Updates

Last Update Posted (Actual)

April 23, 2026

Last Update Submitted That Met QC Criteria

April 20, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCTL019B2003I

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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3
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