Clinical Trial - NCT03601442

CTL019 Out of Specification MAP for ALL or DLBCL Patients

Available

Sponsor: Novartis Pharmaceuticals

Collaborators:

Information provided by (Responsible party): Sponsor

ClinicalTrials.gov Identifier: NCT03601442

Protocol Info

Short Description: CTL019 Out of Specification MAP for ALL or DLBCL Patients
Long Description: 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
MGH Status: Open
Sponsor: Novartis
Disease Program: Cellular

Next Steps


If you are interested in this protocol or in other treatment options at Massachusetts General Hospital, please Request a Consultation.




Purpose

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.
Condition Title Intervention Phase
Acute Lymphoblastic Leukemia (ALL) Diffuse Large B-cell Lymphoma (DLBCL) CTL019
Study Type Expanded Access
Official Title Managed Access Program (MAP) to Provide Access to CTL019, for ALL or DLBCL Patients With Out of Specification Leukapheresis Product and/or Manufactured Tisagenlecleucel Out of Specification for Commercial Release

Primary Outcome Measures


Secondary Outcome Measures

Estimated Enrollment:
Study Start Date:
Estimated Study Completion Date:
Estimated Primary Completion Date:

Eligibility

Ages Eligible for Study: N/A

Genders Eligible for Study: All

Accepts Healthly Volunteers: No

Inclusion Criteria:

  • Written informed consent must be obtained prior to any screening procedures or treatment assignment.
  • Has a patient specific batch of CTL019 which is out of specification either due to out of specification incoming apheresis or final product not meeting commercial release.
  • Not excluded from commercial manufacturing under the prescribing guidelines for their country
  • Out of specification material has not been deemed to pose an undue safety risk to the patient
  • Is suffering from a serious or life-threatening disease or condition
  • Repeat leukapheresis is not feasible per the treating physician assessment
  • Does not have access to a comparable or satisfactory alternative treatment
  • Is not eligible for participation in any of the IMP's ongoing clinical trials or has recently completed a clinical trial that has been terminated and, after considering other options, the clinical team has determined that treatment is necessary and there are no other feasible alternatives for the patient
  • Meets any other relevant medical criteria for compassionate use of the investigational product
  • Is not being transferred from an ongoing clinical trial for which they are still eligible

Exclusion Criteria:

  • Product can be commercially manufactured per the specification of the country in which treatment will occur.
  • Patients who are able to repeat leukapheresis.
  • Evidence of CD19 negative disease
  • HIV positive patients
  • Patients with active replication of Hep B or active or latent Hep C
  • History of hypersensitivity to any drugs or metabolites of similar chemical classes as tisagenlecleucel.
  • Uncontrolled active infection or inflammation
  • History of unstable angina or MI within 6 months prior to screening
  • Any medical condition identified by the investigator that may impact the assessment of the safety or efficacy outcomes in relation to study treatment

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT03601442

Locations

  • United States, Alabama
    • Children's Hospital Alabama Birmingham, Alabama, United States, 35233
  • United States, Arizona
    • Phoenix Children's Hospital Phoenix, Arizona, United States, 85016
    • Mayo AZ Phoenix, Arizona, United States, 85054
    • Banner University Medical Center of Arizona -Tucson Tucson, Arizona, United States, 85724
  • United States, California
    • UCSD La Jolla, California, United States, 92093
    • CHLA Los Angeles, California, United States, 90027
    • UCLA Los Angeles, California, United States, 90095
    • Stanford University, Lucile Packard Children's Hospital Palo Alto, California, United States, 94304
    • Stanford Palo Alto, California, United States, 94304
    • Rady Childrens - UCSD San Diego, California, United States, 92123
  • United States, Colorado
    • University of Colorado - Children's Hospital Colorado Aurora, Colorado, United States, 80045
    • University of Colorado Aurora, Colorado, United States, 80045
  • United States, Connecticut
    • Yale New Haven, Connecticut, United States, 06511
  • United States, Delaware
    • Christiana Care Wilmington, Delaware, United States, 19801
  • United States, District of Columbia
    • Children's National Washington, District of Columbia, United States, 20010
  • United States, Florida
    • University of Miami Coral Gables, Florida, United States, 33146
    • Mayo Jacksonville, Florida, United States, 32224
    • Johns Hopkins - All Children's Hospital Saint Petersburg, Florida, United States, 33701
    • Moffitt Tampa, Florida, United States, 33612
  • United States, Georgia
    • Northside Hospital Atlanta Atlanta, Georgia, United States, 30042
    • CHOA Atlanta, Georgia, United States, 30322
    • Emory Atlanta, Georgia, United States, 30322
  • United States, Illinois
    • Lurie Children's Hospital of Chicago Chicago, Illinois, United States, 60611
    • RUSH Chicago, Illinois, United States, 60612
    • University of Chicago Chicago, Illinois, United States, 60637
  • United States, Indiana
    • Indiana University Health - Riley Hospital for Children - Indiana University Indianapolis, Indiana, United States, 46202
  • United States, Iowa
    • University of Iowa Iowa City, Iowa, United States, 52242
  • United States, Kansas
    • University of Kansas Kansas City, Kansas, United States, 66160
  • United States, Maryland
    • University of Maryland Baltimore, Maryland, United States, 21201
    • Johns Hopkins University Baltimore, Maryland, United States, 21287
  • United States, Massachusetts
    • Dana Farber Cancer Institute - DFCI/MGH/BWH/Boston Childrens Boston, Massachusetts, United States, 02494
    • Tufts Boston, Massachusetts, United States, 62111
  • United States, Michigan
    • University of Michigan Ann Arbor, Michigan, United States, 48109
    • Karmanos Detroit, Michigan, United States, 48201
    • Henry Ford Health System/University Hospital Detroit, Michigan, United States, 48202
    • Spectrum Health Grand Rapids, Michigan, United States, 49503
  • United States, Minnesota
    • University of Minnesota Minneapolis, Minnesota, United States, 55455
    • Mayo Rochester Rochester, Minnesota, United States, 55905
  • United States, Missouri
    • Children's Mercy Hospital Kansas City, Missouri, United States, 64108
    • University of St Louis SSM Health Cardinal Glennon Saint Louis, Missouri, United States, 63103
    • Washington University School of Medicine - Children's Hospital Saint Louis, Missouri, United States, 63110
    • Washington University School of Medicine - Jewish Barnes Saint Louis, Missouri, United States, 63110
  • United States, Nebraska
    • University of Nebraska Omaha, Nebraska, United States, 68198
  • United States, New Jersey
    • Hackensack University Hospital Hackensack, New Jersey, United States, 07601
    • CINJ/Rutgers New Brunswick, New Jersey, United States, 08901
  • United States, New York
    • Roswell Buffalo, New York, United States, 14203
    • Columbia University and New York and Presbyterian Hospital New York, New York, United States, 10032
    • Cornell New York, New York, United States, 10065
    • MSKCC New York, New York, United States, 10065
  • United States, North Carolina
    • UNC Chapel Hill, North Carolina, United States, 27599
    • Duke Durham, North Carolina, United States, 27705
  • United States, Ohio
    • Cincinnati Children's Hospital Cincinnati, Ohio, United States, 45229
    • Jewish Mercy Hospital Cincinnati, Ohio, United States, 45236
    • University Hospital - Case Western Reserve/Seidman Cancer Center Cleveland, Ohio, United States, 44106
    • University Hospital - Rainbow Babies Cleveland, Ohio, United States, 44106
    • Cleveland Clinic Cleveland, Ohio, United States, 44195
    • Nationwide Children's Columbus, Ohio, United States, 43205
    • The Ohio State University Columbus, Ohio, United States, 43210
  • United States, Oregon
    • OHSU Portland, Oregon, United States, 97239
  • United States, Pennsylvania
    • CHOP Philadelphia, Pennsylvania, United States, 19104
    • University of Pennsylvania Philadelphia, Pennsylvania, United States, 19104
    • University of Pittsburgh Medical Center - Children's Pittsburgh, Pennsylvania, United States, 15219
  • United States, South Carolina
    • Medical University of South Carolina Charleston, South Carolina, United States, 29425
  • United States, South Dakota
    • Avera McKennan Sioux Falls, South Dakota, United States, 57105
  • United States, Tennessee
    • Methodist Healthcare-Memphis Hospital Memphis, Tennessee, United States, 38174
    • Sarah Cannon Cancer Center - HCA/Tristar/Centennial Medical Center Nashville, Tennessee, United States, 37203
  • United States, Texas
    • St. David's South Medical Center Austin Texas Austin, Texas, United States, 78704
    • Medical City Dallas Texas Dallas, Texas, United States, 57230
    • UTSW Dallas, Texas, United States, 75390
    • Houston Methodist Hospital - Baylor College of Medicine Houston, Texas, United States, 77030
    • MDACC Houston, Texas, United States, 77030
    • TCH Houston, Texas, United States, 77030
    • Methodist San Antonio San Antonio, Texas, United States, 78229
  • United States, Utah
    • Huntsman Cancer Institute - University of Utah Salt Lake City, Utah, United States, 84112
  • United States, Virginia
    • University of Virginia Charlottesville, Virginia, United States, 22903
    • Virginia Commonwealth University Richmond, Virginia, United States, 23124
  • United States, Washington
    • Seattle Cancer Care Seattle, Washington, United States, 98109
  • United States, West Virginia
    • WVU Morgantown, West Virginia, United States, 26506
  • United States, Wisconsin
    • University of Wisconsin Hospital and Clinics Madison, Wisconsin, United States, 53792
    • Children's Hospital of Wisconsin Milwaukee, Wisconsin, United States, 53226
    • Medical College of Wisconsin - Froedtert Hospital Milwaukee, Wisconsin, United States, 53226
  • Canada, Ontario
    • Novartis Investigative Site Hamilton, Ontario, Canada, L8V 1C3

Sponsors and Collaborators

Novartis Pharmaceuticals

More Information

No publications provided

Responsible Party: Sponsor
ClinicalTrials.gov Identifier: NCT03601442
Other Study ID Numbers:
Study First Received:
Last Updated:
Health Authority:

Keywords provided by Novartis:

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

Additional relevant MeSH terms:

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Lymphoma, B-Cell

Lymphoma, Large B-Cell, Diffuse

Next Steps


If you are interested in this protocol or in other treatment options at Massachusetts General Hospital, please Request a Consultation.







ClinicalTrials.gov processed this data on April 09, 2020