CTL019 Out of Specification MAP for ALL or DLBCL Patients

February 7, 2024 updated by: Novartis Pharmaceuticals

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®)

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.

Study Overview

Status

Available

Conditions

Intervention / Treatment

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.

Study Type

Expanded Access

Expanded Access Type

  • 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
      • Saint 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
      • Saint 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)

Accepts Healthy Volunteers

No

Description

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.

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

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)

February 8, 2024

Last Update Submitted That Met QC Criteria

February 7, 2024

Last Verified

February 1, 2024

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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Locations

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