Acute Lymphoblastic Leukemia (ALL) Clinical Trial
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®)
| NCT number | NCT03601442 |
| Other study ID # | CCTL019B2003I |
| Secondary ID | |
| Status | Available |
| Phase | |
| First received | |
| Last updated |
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.
| Status | Available |
| Enrollment | 0 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 1 Day to 25 Years |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Australia | Novartis Investigative Site | Murdoch | Western Australia |
| Canada | Novartis Investigative Site | Montreal | Quebec |
| Canada | Novartis Investigative Site | Toronto | Ontario |
| United States | University of Michigan Health System | Ann Arbor | Michigan |
| United States | University of Michigan IRB | Ann Arbor | Michigan |
| United States | University of Michigan Medical Center | Ann Arbor | Michigan |
| United States | Children's Healthcare of Atlanta Cellular Therapies Lab | Atlanta | Georgia |
| United States | Emory University School of Medicine Emory University (12) | Atlanta | Georgia |
| United States | Emory University School of Medicine/Winship Cancer Institute | Atlanta | Georgia |
| United States | Emory University School of Medicine/Winship Cancer Institute Winship Cancer Center | Atlanta | Georgia |
| United States | Northside Hospital | Atlanta | Georgia |
| United States | Johns Hopkins Outpatient Center | Baltimore | Maryland |
| United States | Johns Hopkins University Hospital | Baltimore | Maryland |
| United States | University of Maryland | Baltimore | Maryland |
| United States | University of Maryland Medical Center | Baltimore | Maryland |
| United States | University of Maryland Medical Center UMMC | Baltimore | Maryland |
| United States | Dana Farber Cancer Institute | Boston | Massachusetts |
| United States | Dana Farber Cancer Institute Dana Farber Cancer Institute | Boston | Massachusetts |
| United States | Dana-Farber Cancer Institute | Boston | Massachusetts |
| United States | Massachusetts General Hospital | Boston | Massachusetts |
| United States | Massachusetts General Hospital Cancer Center | Boston | Massachusetts |
| United States | Massachusetts General Hospital DF/HCC institutions | Boston | Massachusetts |
| United States | MGH Cancer Center | Boston | Massachusetts |
| United States | MGH Cancer Center MGH Cancer Center | Boston | Massachusetts |
| United States | Tufts Medical Center | Boston | Massachusetts |
| United States | Roswell Park Cancer Institute | Buffalo | New York |
| United States | Roswell Park Cancer Institute Rosewell | Buffalo | 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 | Medical University of South Carolina MUSC | Charleston | South Carolina |
| United States | Atrium Heath | Charlotte | North Carolina |
| United States | University of Virginia Health Systems UVA | Charlottesville | Virginia |
| United States | Ann and Robert H Lurie Childrens Hospital of Chicago | Chicago | Illinois |
| United States | Northwestern | Chicago | Illinois |
| United States | University of Chicago | Chicago | Illinois |
| United States | University of CHicago Comer Children's Hospital Regulatory | Chicago | Illinois |
| United States | University of Illinois at Chicago | Chicago | Illinois |
| 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 Comprehensive Cancer Center Ohio State UMC James Cancer Ct | Columbus | Ohio |
| United States | The Ohio State University Hospitals Clinic | Columbus | Ohio |
| United States | The Ohio State University Hospitals Clinic The Ohio State University | Columbus | Ohio |
| United States | The Ohio State University Regulatory | Columbus | Ohio |
| United States | Texas Cancer Center ( Medical City Dallas Hospital) TX Cancer Center | Dallas | Texas |
| United States | U of TX Southwestern Medical Center - SimmonsCompCancerCtr Satellite | Dallas | Texas |
| United States | Univof Texas Southwestern Medical Center, Dept of Pediatrics | 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 | Children's Hospital Colorado | Denver | Colorado |
| United States | Henry Ford Hospital Henry Ford | Detroit | 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 | City of Hope | Duarte | California |
| United States | City of Hope National Medical Center Hematology&HematCellTransplant | Duarte | California |
| United States | Duke University Medical Center | Durham | North Carolina |
| United States | Duke University Medical Center Dept. of DUMC (4) | Durham | North Carolina |
| United States | Hematology Oncology Center, Inc. | Elyria | Ohio |
| United States | Cook Children's | Fort Worth | Texas |
| United States | Banner MDACC | Gilbert | Arizona |
| United States | Prisma Health Cancer Institute | Greenville | South Carolina |
| United States | Hackensack University Medical Center Hackensack UMC | Hackensack | New Jersey |
| United States | Hackensack University Medical Center Onc Dept | Hackensack | New Jersey |
| 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 | 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 | Methodist Hospital / Methodist Cancer Center Houston Methodist Hospital | Houston | Texas |
| United States | Texas Children's Hospital Baylor College of Medicine | Houston | Texas |
| United States | Children's Hospital Los Angeles | Los Angeles | California |
| United States | Children's Hospital Los Angeles CRFB002H2301 | 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 | Healthwatch Plaza Research Associates | Louisville | Kentucky |
| United States | University of Wisconsin Hospital and Clinics | Madison | Wisconsin |
| 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 Wisconsin Children's Hospital | Madison | Wisconsin |
| United States | Methodist University Hospital Blood and Marrow Transplant | Memphis | Tennessee |
| United States | University of Miami Hospital | Miami | Florida |
| United States | Childrens Hospital of Wisconsin | Milwaukee | Wisconsin |
| United States | Medical College of Wisconsin Med College of WI (29) | Milwaukee | Wisconsin |
| United States | University of Minnesota | Minneapolis | Minnesota |
| United States | University of Minnesota Masonic Childrens Hospital | Minneapolis | Minnesota |
| 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 | Yale Cancer Center | New Haven | Connecticut |
| 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 | New York | New York |
| United States | Memorial Sloan Kettering Cancer Center | New York | New York |
| United States | Memorial Sloan Kettering Cancer Center MSKCC | New York | New York |
| United States | Memorial Sloan Kettering Cancer Center MSKCC (9) | New York | New York |
| United States | Memorial Sloan Kettering Cancer Center Oncology | New York | New York |
| 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 | Children s Hospital of Philadelphia | Philadelphia | Pennsylvania |
| United States | Children s Hospital of Philadelphia Patient Treatment | Philadelphia | Pennsylvania |
| United States | Children's Hospital of Philadelphia | Philadelphia | Pennsylvania |
| United States | Children's Hospital of Philadelphia Children's Hospital Of Phil(2) | Philadelphia | Pennsylvania |
| United States | Childrens Hospital of Philadelphia CTRB 3006 | Philadelphia | Pennsylvania |
| United States | Fox Chase Cancer Center | Philadelphia | Pennsylvania |
| United States | Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania |
| United States | Pennsylvania Oncology/Hemotology Dept.ofPenn. Onc./Hem. | 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 | Thomas Jefferson University Hospital | Philadelphia | Pennsylvania |
| United States | University of Pennsylvania | Philadelphia | Pennsylvania |
| United States | University of Pennsylvania Health System CERL080AUS90 | Philadelphia | Pennsylvania |
| 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 | University of Arizona Cancer Center | Phoenix | Arizona |
| United States | University of Pittsburgh Cancer Institute | Pittsburgh | Pennsylvania |
| United States | OHSU | Portland | Oregon |
| United States | Oregon Health and Science University | Portland | Oregon |
| United States | Oregon Health and Science University | Portland | Oregon |
| United States | Oregon Health Sciences University | Portland | Oregon |
| United States | VCU Health Systems, MCV | Richmond | Virginia |
| United States | Mayo CLinic | Rochester | Minnesota |
| United States | WUSTL Jewish Barnes | Saint Louis | Missouri |
| United States | JHMI All Children s Hospital | Saint Petersburg | Florida |
| United States | LDS Hospital | Salt Lake City | Utah |
| United States | Primary Childrens Medical Center Oncology | Salt Lake City | Utah |
| United States | University of Utah / Huntsman Cancer Institute Huntsman Cancer Cente | Salt Lake City | Utah |
| United States | Methodist Healthcare System | San Antonio | Texas |
| United States | Methodist Hospital | San Antonio | Texas |
| United States | Rady Children s Hospital Dept of Oncology | San Diego | California |
| United States | Rady Childrens Hospital | San Diego | 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 | 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 | Fred Hutchinson Cancer Research Center Dept. of FHCRC | Seattle | Washington |
| United States | Avera McKennan Hospital and University Health Center | Sioux Falls | South Dakota |
| United States | Stanford Healthcare | Stanford | California |
| United States | Banner Uni Medical Center Tucson | Tucson | Arizona |
| Lead Sponsor | Collaborator |
|---|---|
| Novartis Pharmaceuticals |
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