CTL019 Out of Specification MAP for ALL or DLBCL Patients
Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Available
CT.gov ID
NCT03601442
Collaborator
(none)
146
Study Details
Study Description
Brief Summary
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 or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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 Design
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
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
Ages Eligible for Study:
1 Day
to 25 Years
Sexes Eligible for Study:
All
Accepts Healthy 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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Banner MDACC | Gilbert | Arizona | United States | 85234 |
| 2 | University of Arizona Cancer Center | Phoenix | Arizona | United States | 85004 |
| 3 | Banner University of Arizona Medical Center | Phoenix | Arizona | United States | 85006 |
| 4 | Phoenix Children's Hospital | Phoenix | Arizona | United States | 85016 |
| 5 | Phoenix Childrens Hospital | Phoenix | Arizona | United States | 85016 |
| 6 | Banner Uni Medical Center Tucson | Tucson | Arizona | United States | 85724 |
| 7 | City of Hope National Medical Center Hematology&HematCellTransplant | Duarte | California | United States | 91010 3000 |
| 8 | City of Hope | Duarte | California | United States | 91010 |
| 9 | Children's Hospital Los Angeles CRFB002H2301 | Los Angeles | California | United States | 90027 |
| 10 | Children's Hospital Los Angeles | Los Angeles | California | United States | 90027 |
| 11 | Childrens Hospital Los Angeles | Los Angeles | California | United States | 90027 |
| 12 | Mattel Childrens Hospital UCLA | Los Angeles | California | United States | 90095 |
| 13 | University of California at Los Angeles UCLA | Los Angeles | California | United States | 90095 |
| 14 | Lucile Packard Children s Hospital Stanford University | Palo Alto | California | United States | 94304 |
| 15 | Lucile Packard Childrens Hospital | Palo Alto | California | United States | 94304 |
| 16 | Stanford University Medical Center | Palo Alto | California | United States | 94304 |
| 17 | UC San Diego | San Diego | California | United States | 92093-0979 |
| 18 | University of California at San Diego, Moores Cancer Ctr UCSD | San Diego | California | United States | 92103 |
| 19 | Rady Children s Hospital Dept of Oncology | San Diego | California | United States | 92123 |
| 20 | Rady Childrens Hospital | San Diego | California | United States | 92123 |
| 21 | Ucsf Benioff Childrens Hospital Pediatric Hematology Oncology | San Francisco | California | United States | 94143 |
| 22 | University of Califronia San Francisco | San Francisco | California | United States | 94143 |
| 23 | University of California, Los Angeles | Santa Monica | California | United States | 90904 |
| 24 | Stanford Healthcare | Stanford | California | United States | 94304 |
| 25 | Children's Hospital Colorado | Denver | Colorado | United States | 80218 |
| 26 | Yale Cancer Center | New Haven | Connecticut | United States | 06520 |
| 27 | University of Miami Hospital | Miami | Florida | United States | 33136 |
| 28 | JHMI All Children s Hospital | Saint Petersburg | Florida | United States | 33701 |
| 29 | Emory University School of Medicine Emory University (12) | Atlanta | Georgia | United States | 30322 |
| 30 | Emory University School of Medicine/Winship Cancer Institute Winship Cancer Center | Atlanta | Georgia | United States | 30322 |
| 31 | Emory University School of Medicine/Winship Cancer Institute | Atlanta | Georgia | United States | 30322 |
| 32 | Children's Healthcare of Atlanta Cellular Therapies Lab | Atlanta | Georgia | United States | 30342 |
| 33 | Northside Hospital | Atlanta | Georgia | United States | 30342 |
| 34 | Ann and Robert H Lurie Childrens Hospital of Chicago | Chicago | Illinois | United States | 60611 |
| 35 | Northwestern | Chicago | Illinois | United States | 60611 |
| 36 | University of Illinois at Chicago | Chicago | Illinois | United States | 60612 |
| 37 | University of CHicago Comer Children's Hospital Regulatory | Chicago | Illinois | United States | 60637-1470 |
| 38 | University of Chicago | Chicago | Illinois | United States | 60637 |
| 39 | Healthwatch Plaza Research Associates | Louisville | Kentucky | United States | 40217 |
| 40 | University of Maryland Medical Center UMMC | Baltimore | Maryland | United States | 21201 |
| 41 | University of Maryland Medical Center | Baltimore | Maryland | United States | 21201 |
| 42 | University of Maryland | Baltimore | Maryland | United States | 21201 |
| 43 | Johns Hopkins Outpatient Center | Baltimore | Maryland | United States | 21287 |
| 44 | Johns Hopkins University Hospital | Baltimore | Maryland | United States | 21287 |
| 45 | Tufts Medical Center | Boston | Massachusetts | United States | 02111 |
| 46 | Massachusetts General Hospital Cancer Center | Boston | Massachusetts | United States | 02114 |
| 47 | Massachusetts General Hospital DF/HCC institutions | Boston | Massachusetts | United States | 02114 |
| 48 | Massachusetts General Hospital | Boston | Massachusetts | United States | 02114 |
| 49 | MGH Cancer Center MGH Cancer Center | Boston | Massachusetts | United States | 02114 |
| 50 | MGH Cancer Center | Boston | Massachusetts | United States | 02114 |
| 51 | Dana Farber Cancer Institute Dana Farber Cancer Institute | Boston | Massachusetts | United States | 02215 |
| 52 | Dana Farber Cancer Institute | Boston | Massachusetts | United States | 02215 |
| 53 | Dana-Farber Cancer Institute | Boston | Massachusetts | United States | 02215 |
| 54 | University of Michigan IRB | Ann Arbor | Michigan | United States | 48109-2800 |
| 55 | University of Michigan Medical Center | Ann Arbor | Michigan | United States | 48109-5848 |
| 56 | University of Michigan Health System | Ann Arbor | Michigan | United States | 48109 |
| 57 | Karmanos Cancer Institute | Detroit | Michigan | United States | 48201 |
| 58 | Moffitt Cancer Center | Detroit | Michigan | United States | 48201 |
| 59 | Wayne State University - Karmanos Cancer Institute | Detroit | Michigan | United States | 48201 |
| 60 | Henry Ford Hospital Henry Ford | Detroit | Michigan | United States | 48202 2689 |
| 61 | University of Minnesota Masonic Childrens Hospital | Minneapolis | Minnesota | United States | 55455 |
| 62 | University of Minnesota | Minneapolis | Minnesota | United States | 55455 |
| 63 | Mayo CLinic | Rochester | Minnesota | United States | 55905 |
| 64 | WUSTL Jewish Barnes | Saint Louis | Missouri | United States | 63110 |
| 65 | Hackensack University Medical Center Hackensack UMC | Hackensack | New Jersey | United States | 07601 |
| 66 | Hackensack University Medical Center Onc Dept | Hackensack | New Jersey | United States | 07601 |
| 67 | Robert Wood Johnson Medical School | New Brunswick | New Jersey | United States | 08901 |
| 68 | Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | United States | 08903 |
| 69 | Roswell Park Cancer Institute Rosewell | Buffalo | New York | United States | 14263 |
| 70 | Roswell Park Cancer Institute | Buffalo | New York | United States | 14263 |
| 71 | Memorial Sloan Kettering | New York | New York | United States | 10017 |
| 72 | Memorial Sloan Kettering Cancer Center MSKCC | New York | New York | United States | 10021 |
| 73 | Memorial Sloan Kettering Cancer Center Oncology | New York | New York | United States | 10021 |
| 74 | Columbia University Medical Center New York Presbyterian CUMC Research Pharmacy | New York | New York | United States | 10032 |
| 75 | Columbia University Medical Center New York Presbyterian Neuroendocrine Unit | New York | New York | United States | 10032 |
| 76 | Memorial Sloan Kettering Cancer Center MSKCC (9) | New York | New York | United States | 10065 |
| 77 | Memorial Sloan Kettering Cancer Center | New York | New York | United States | 10065 |
| 78 | University of North Carolina Chapel Hill Physician Office Building | Chapel Hill | North Carolina | United States | 27514 |
| 79 | University of North Carolina Health System | Chapel Hill | North Carolina | United States | 27599 |
| 80 | Atrium Heath | Charlotte | North Carolina | United States | 28203 |
| 81 | Duke University Medical Center Dept. of DUMC (4) | Durham | North Carolina | United States | 27710 |
| 82 | Duke University Medical Center | Durham | North Carolina | United States | 27710 |
| 83 | Cincinnati Children s Hospital Medical Center | Cincinnati | Ohio | United States | 45229-3039 |
| 84 | Cincinnati Childrens Hospital | Cincinnati | Ohio | United States | 45229 |
| 85 | Oncology Hematology Care Inc Drug Shipment | Cincinnati | Ohio | United States | 45242 |
| 86 | University Hospitals Cleveland Medical Center Univ. Hospitals of Cleveland | Cleveland | Ohio | United States | 44106-5028 |
| 87 | Nationwide Childrens Hospital Center | Columbus | Ohio | United States | 43205 |
| 88 | OSU Wexner MC James CH | Columbus | Ohio | United States | 43210 |
| 89 | The Ohio State University Hospitals Clinic The Ohio State University | Columbus | Ohio | United States | 43210 |
| 90 | The Ohio State University Hospitals Clinic | Columbus | Ohio | United States | 43210 |
| 91 | The Ohio State University Regulatory | Columbus | Ohio | United States | 43210 |
| 92 | The Ohio State University Comprehensive Cancer Center Ohio State UMC James Cancer Ct | Columbus | Ohio | United States | 43221 |
| 93 | Hematology Oncology Center, Inc. | Elyria | Ohio | United States | 44035 |
| 94 | Oregon Health Sciences University | Portland | Oregon | United States | 97201 |
| 95 | Oregon Health and Science University | Portland | Oregon | United States | 97239-3098 |
| 96 | OHSU | Portland | Oregon | United States | 97239 |
| 97 | Oregon Health and Science University | Portland | Oregon | United States | 97239 |
| 98 | Childrens Hospital of Philadelphia CTRB 3006 | Philadelphia | Pennsylvania | United States | 19104 4399 |
| 99 | Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | United States | 19104-4283 |
| 100 | Children's Hospital of Philadelphia Children's Hospital Of Phil(2) | Philadelphia | Pennsylvania | United States | 19104-4318 |
| 101 | Children s Hospital of Philadelphia Patient Treatment | Philadelphia | Pennsylvania | United States | 19104-4399 |
| 102 | Children s Hospital of Philadelphia | Philadelphia | Pennsylvania | United States | 19104-4399 |
| 103 | University of Pennsylvania | Philadelphia | Pennsylvania | United States | 19104-6149 |
| 104 | Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | United States | 19104 |
| 105 | The Childrens Hospital of Philadelphia Children's Hosp Philadelphia | Philadelphia | Pennsylvania | United States | 19104 |
| 106 | The Childrens Hospital of Philadelphia Pediatric Oncology/Stem Cell T | Philadelphia | Pennsylvania | United States | 19104 |
| 107 | The Childrens Hospital of Philadelphia Regulatory | Philadelphia | Pennsylvania | United States | 19104 |
| 108 | University of Pennsylvania Health System CERL080AUS90 | Philadelphia | Pennsylvania | United States | 19104 |
| 109 | Pennsylvania Oncology/Hemotology Dept.ofPenn. Onc./Hem. | Philadelphia | Pennsylvania | United States | 19106 |
| 110 | Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | United States | 19107 |
| 111 | Fox Chase Cancer Center | Philadelphia | Pennsylvania | United States | 19111 |
| 112 | University of Pittsburgh Cancer Institute | Pittsburgh | Pennsylvania | United States | 15232 |
| 113 | Medical University of South Carolina MUSC | Charleston | South Carolina | United States | 29425 |
| 114 | Prisma Health Cancer Institute | Greenville | South Carolina | United States | 29601 |
| 115 | Avera McKennan Hospital and University Health Center | Sioux Falls | South Dakota | United States | 57105 |
| 116 | Methodist University Hospital Blood and Marrow Transplant | Memphis | Tennessee | United States | 38104 |
| 117 | Texas Cancer Center ( Medical City Dallas Hospital) TX Cancer Center | Dallas | Texas | United States | 75230 |
| 118 | Univof Texas Southwestern Medical Center, Dept of Pediatrics | Dallas | Texas | United States | 75235 |
| 119 | U of TX Southwestern Medical Center - SimmonsCompCancerCtr Satellite | Dallas | Texas | United States | 75390 |
| 120 | UT Southwestern Medical Center Pediatric Hematology/Onc | Dallas | Texas | United States | 75390 |
| 121 | UT Southwestern Medical Center UT SW Medical Ctr of Dallas | Dallas | Texas | United States | 75390 |
| 122 | Texas Children's Hospital Baylor College of Medicine | Houston | Texas | United States | 77030-2399 |
| 123 | Baylor College of Medicine | Houston | Texas | United States | 77030 |
| 124 | Houston Methodist Cancer Center Methodist Cancer Center (2) | Houston | Texas | United States | 77030 |
| 125 | Houston Methodist Hospital | Houston | Texas | United States | 77030 |
| 126 | MD Anderson Cancer Center/University of Texas MDACC | Houston | Texas | United States | 77030 |
| 127 | MD Anderson Cancer Center/University of Texas StudyCoordinator:CTKI258A2102 | Houston | Texas | United States | 77030 |
| 128 | MD Anderson Cancer Center | Houston | Texas | United States | 77030 |
| 129 | Methodist Hospital / Methodist Cancer Center Houston Methodist Hospital | Houston | Texas | United States | 77030 |
| 130 | Methodist Healthcare System | San Antonio | Texas | United States | 78229 |
| 131 | Methodist Hospital | San Antonio | Texas | United States | 78229 |
| 132 | University of Utah / Huntsman Cancer Institute Huntsman Cancer Center | Salt Lake City | Utah | United States | 84103 |
| 133 | Primary Childrens Medical Center Oncology | Salt Lake City | Utah | United States | 84113 |
| 134 | LDS Hospital | Salt Lake City | Utah | United States | 84132 |
| 135 | University of Virginia Health Systems UVA | Charlottesville | Virginia | United States | 22908-0334 |
| 136 | VCU Health Systems, MCV | Richmond | Virginia | United States | 23298 |
| 137 | Fred Hutchinson Cancer Research Center Dept. of FHCRC | Seattle | Washington | United States | 98109 |
| 138 | University of Wisconsin Hospital and Clinics | Madison | Wisconsin | United States | 53705-3611 |
| 139 | University of Wisconsin Hospital and Clinics Hematopoietic Stem Cell Lab | Madison | Wisconsin | United States | 53792 |
| 140 | University of Wisconsin Hospital and Clinics | Madison | Wisconsin | United States | 53792 |
| 141 | University Wisconsin Children's Hospital | Madison | Wisconsin | United States | 53792 |
| 142 | Childrens Hospital of Wisconsin | Milwaukee | Wisconsin | United States | 53226 |
| 143 | Medical College of Wisconsin Med College of WI (29) | Milwaukee | Wisconsin | United States | 53226 |
| 144 | Novartis Investigative Site | Murdoch | Western Australia | Australia | 6150 |
| 145 | Novartis Investigative Site | Toronto | Ontario | Canada | M5G 1X8 |
| 146 | Novartis Investigative Site | Montreal | Quebec | Canada | H1T 2M4 |
Sponsors and Collaborators
- Novartis Pharmaceuticals
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT03601442
Other Study ID Numbers:
- CCTL019B2003I
First Posted:
Jul 26, 2018
Last Update Posted:
Oct 29, 2021
Last Verified:
Oct 1, 2021
Keywords provided by Novartis Pharmaceuticals
Additional relevant MeSH terms: