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.
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.
Biological: CTL019
CTL019
Other Name: tisagenlecleucel
Other Name: Kymriah
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.
Banner MDACC
Gilbert, Arizona, 85234
Contact: 480-256-3333
Investigator: Sajad Khazal
University of Arizona Cancer Center
Phoenix, Arizona, 85004
Contact: 602-406-8262
Banner University of Arizona Medical Center
Phoenix, Arizona, 85006
Contact: 520-626-3576
Investigator: Emmanuel Katsanis
Phoenix Children's Hospital
Phoenix, Arizona, 85016
Contact: 602-546-0985
Investigator: Dana Salzberg
Phoenix Childrens Hospital
Phoenix, Arizona, 85016
Contact: 602-546-0895
Banner Uni Medical Center Tucson
Tucson, Arizona, 85724
Investigator: Emmanuel Katsanis
City of Hope National Medical Center Hematology&HematCellTransplant
Duarte, California, 91010 3000
Investigator: Leslie Popplewell
City of Hope
Duarte, California, 91010
Contact: 626-930-5452
Children's Hospital Los Angeles CRFB002H2301
Los Angeles, California, 90027
Contact: 323-361-8552
Investigator: Michael Pulsipher
Children's Hospital Los Angeles
Los Angeles, California, 90027
Contact: 323-660-2450
Investigator: Michael Pulsipher
Childrens Hospital Los Angeles
Los Angeles, California, 90027
Contact: 323-660-2450
Investigator: Michael Pulsipher
Mattel Childrens Hospital UCLA
Los Angeles, California, 90095
Investigator: James Chng
University of California at Los Angeles UCLA
Los Angeles, California, 90095
Contact: 310-206-2436
Investigator: Josh Sasine
Lucile Packard Children s Hospital Stanford University
Palo Alto, California, 94304
Contact: 650-723-4000
Investigator: Liora Schultz
Lucile Packard Childrens Hospital
Palo Alto, California, 94304
Contact: 650-736-0388
Investigator: Liora Schultz
Stanford University Medical Center
Palo Alto, California, 94304
Investigator: Liora Schultz
UC San Diego
San Diego, California, 92093-0979
Contact: 619-622-5731
Investigator: Dimitrios Tzachanis
University of California at San Diego, Moores Cancer Ctr UCSD
San Diego, California, 92103
Contact: 858-822-5369
Rady Children s Hospital Dept of Oncology
San Diego, California, 92123
Contact: 858-966-5118
Investigator: Deborah Schiff
Rady Childrens Hospital
San Diego, California, 92123
Contact: 858-966-7785
Investigator: Deborah Schiff
Ucsf Benioff Childrens Hospital Pediatric Hematology Oncology
San Francisco, California, 94143
Contact: 415-342-2762
Investigator: Michelle Hermiston
University of Califronia San Francisco
San Francisco, California, 94143
Contact: 415-353-2305
Investigator: Charalambos Andreadis
University of California, Los Angeles
Santa Monica, California, 90904
Contact: 310-582-4069
Investigator: Christopher Seet
Stanford Healthcare
Stanford, California, 94304
Children's Hospital Colorado
Denver, Colorado, 80218
Yale Cancer Center
New Haven, Connecticut, 06520
Contact: 203-200-4363
University of Miami Hospital
Miami, Florida, 33136
JHMI All Children s Hospital
Saint Petersburg, Florida, 33701
Contact: 727-767-4150
Investigator: Gauri Sunkersett
Emory University School of Medicine Emory University (12)
Atlanta, Georgia, 30322
Contact: 404-778-2214
Investigator: Pamela Allen
Emory University School of Medicine/Winship Cancer Institute Winship Cancer Center
Atlanta, Georgia, 30322
Investigator: Jonathon Cohen
Emory University School of Medicine/Winship Cancer Institute
Atlanta, Georgia, 30322
Contact: 404-778-5747
Investigator: Amelia Langston
Children's Healthcare of Atlanta Cellular Therapies Lab
Atlanta, Georgia, 30342
Contact: 404-785-1721
Investigator: Muna Qayed
Northside Hospital
Atlanta, Georgia, 30342
Contact: 404-851-5926
Ann and Robert H Lurie Childrens Hospital of Chicago
Chicago, Illinois, 60611
Contact: 312-227-4779
Northwestern
Chicago, Illinois, 60611
Contact: 312-695-6737
Investigator: Reem Karmali
University of Illinois at Chicago
Chicago, Illinois, 60612
Contact: 312-355-1470
Investigator: Peter Riedell
University of CHicago Comer Children's Hospital Regulatory
Chicago, Illinois, 60637-1470
Investigator: John Cunningham
University of Chicago
Chicago, Illinois, 60637
Investigator: Peter Riedell
Healthwatch Plaza Research Associates
Louisville, Kentucky, 40217
Contact: 502-634-3090
Investigator: Rayne Rouce
University of Maryland Medical Center UMMC
Baltimore, Maryland, 21201
Contact: 410-328-8610
Investigator: Aaron Rapoport
University of Maryland Medical Center
Baltimore, Maryland, 21201
Contact: 410-328-4394
Investigator: Nancy Hardy
University of Maryland
Baltimore, Maryland, 21201
Investigator: Saurabh Dahiya
Johns Hopkins Outpatient Center
Baltimore, Maryland, 21287
Investigator: Patrick Brown
Johns Hopkins University Hospital
Baltimore, Maryland, 21287
Contact: 410-955-6776
Investigator: Patrick Brown
Tufts Medical Center
Boston, Massachusetts, 02111
Contact: 617-636-7462
Investigator: Andreas Klein
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
Contact: 617-726-5765
Investigator: Matthew Frigault
Massachusetts General Hospital DF/HCC institutions
Boston, Massachusetts, 02114
Contact: 617-726-8743
Investigator: Matthew Frigault
Massachusetts General Hospital
Boston, Massachusetts, 02114
Contact: 617-726-8228
Investigator: Matthew Frigault
MGH Cancer Center MGH Cancer Center
Boston, Massachusetts, 02114
Contact: 617-643-3715
Investigator: Matthew Frigault
MGH Cancer Center
Boston, Massachusetts, 02114
Contact: 617-724-0786
Investigator: Matthew Frigault
Dana Farber Cancer Institute Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Contact: 617-632-5607
Investigator: Steven Margossian
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Contact: 617-632-4272
Investigator: Steven Margossian
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Contact: 617-632-4295
Investigator: Caron Jacobson
University of Michigan IRB
Ann Arbor, Michigan, 48109-2800
Investigator: Gregory Yanik
University of Michigan Medical Center
Ann Arbor, Michigan, 48109-5848
Investigator: Mark Vander Lugt
University of Michigan Health System
Ann Arbor, Michigan, 48109
Contact: 734-936-5504
Investigator: Monalisa Ghosh
Karmanos Cancer Institute
Detroit, Michigan, 48201
Contact: 313-576-8994
Investigator: Abinav Deol
Moffitt Cancer Center
Detroit, Michigan, 48201
Contact: 313-576-8712
Investigator: Julio Chavez
Wayne State University - Karmanos Cancer Institute
Detroit, Michigan, 48201
Henry Ford Hospital Henry Ford
Detroit, Michigan, 48202 2689
Contact: 313-916-8862
Investigator: Edward Peres
University of Minnesota Masonic Childrens Hospital
Minneapolis, Minnesota, 55455
Contact: 612-624-9193
Investigator: Heather Stefanski
University of Minnesota
Minneapolis, Minnesota, 55455
Contact: 612-625-9125
Investigator: Fiona He
Mayo CLinic
Rochester, Minnesota, 55905
Contact: 507-284-2505
Investigator: Mohamed Kharfan Dabaja
WUSTL Jewish Barnes
Saint Louis, Missouri, 63110
Investigator: Armin Ghobadi
Hackensack University Medical Center Hackensack UMC
Hackensack, New Jersey, 07601
Contact: 201-615-7251
Investigator: Michele Donato
Hackensack University Medical Center Onc Dept
Hackensack, New Jersey, 07601
Contact: 551-996-8849
Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08901
Investigator: Andrew Evens
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
Contact: 732-235-6031
Roswell Park Cancer Institute Rosewell
Buffalo, New York, 14263
Contact: 716-845-4886
Investigator: Mathew Barth
Roswell Park Cancer Institute
Buffalo, New York, 14263
Contact: 716-845-4485
Investigator: Philip McCarthy
Memorial Sloan Kettering
New York, New York, 10017
Memorial Sloan Kettering Cancer Center MSKCC
New York, New York, 10021
Contact: 646-227-2131
Investigator: Lia Palomba
Memorial Sloan Kettering Cancer Center Oncology
New York, New York, 10021
Contact: 212-639-3859
Investigator: Craig Sauter
Columbia University Medical Center New York Presbyterian CUMC Research Pharmacy
New York, New York, 10032
Contact: 646-317-4850
Investigator: Prakash Satwani
Columbia University Medical Center New York Presbyterian Neuroendocrine Unit
New York, New York, 10032
Contact: 212-305-4921
Investigator: Prakash Satwani
Memorial Sloan Kettering Cancer Center MSKCC (9)
New York, New York, 10065
Contact: 646-888-0992
Investigator: Craig Sauter
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Investigator: Michael Scordo
University of North Carolina Chapel Hill Physician Office Building
Chapel Hill, North Carolina, 27514
Contact: 919-843-5497
University of North Carolina Health System
Chapel Hill, North Carolina, 27599
Investigator: Natalie Sophia Grover
Atrium Heath
Charlotte, North Carolina, 28203
Investigator: Jeffrey Huo
Duke University Medical Center Dept. of DUMC (4)
Durham, North Carolina, 27710
Contact: 919-668-1043
Duke University Medical Center
Durham, North Carolina, 27710
Cincinnati Children s Hospital Medical Center
Cincinnati, Ohio, 45229-3039
Contact: 800-344-2462
Investigator: Christine Phillips
Cincinnati Childrens Hospital
Cincinnati, Ohio, 45229
Contact: 513-636-0606
Investigator: Christine Phillips
Oncology Hematology Care Inc Drug Shipment
Cincinnati, Ohio, 45242
Contact: 513-751-2273
University Hospitals Cleveland Medical Center Univ. Hospitals of Cleveland
Cleveland, Ohio, 44106-5028
Contact: 216-844-7164
Investigator: Kirsten Boughan
Nationwide Childrens Hospital Center
Columbus, Ohio, 43205
Investigator: Rajinder Bajwa
OSU Wexner MC James CH
Columbus, Ohio, 43210
Investigator: Jonathan Brammer
The Ohio State University Hospitals Clinic The Ohio State University
Columbus, Ohio, 43210
Investigator: Samantha Jaglowski
The Ohio State University Hospitals Clinic
Columbus, Ohio, 43210
Contact: 614-293-2887
Investigator: Samantha Jaglowski
The Ohio State University Regulatory
Columbus, Ohio, 43210
Contact: 614-366-0542
Investigator: Samantha Jaglowski
The Ohio State University Comprehensive Cancer Center Ohio State UMC James Cancer Ct
Columbus, Ohio, 43221
Contact: 614-688-6563
Investigator: Samantha Jaglowski
Hematology Oncology Center, Inc.
Elyria, Ohio, 44035
Contact: 440-324-0425
Investigator: Theodore Laetsch
Oregon Health Sciences University
Portland, Oregon, 97201
Contact: 503-494-5431
Oregon Health and Science University
Portland, Oregon, 97239-3098
Contact: 503-494-5893
OHSU
Portland, Oregon, 97239
Contact: 503-494-0896
Oregon Health and Science University
Portland, Oregon, 97239
Contact: 503-418-2294
Investigator: Brandon Hayes-Lattin Hayes-Lattin
Childrens Hospital of Philadelphia CTRB 3006
Philadelphia, Pennsylvania, 19104 4399
Contact: 215-590-5476
Investigator: Stephan Grupp
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104-4283
Contact: 215-662-6394
Investigator: Stephen Schuster
Children's Hospital of Philadelphia Children's Hospital Of Phil(2)
Philadelphia, Pennsylvania, 19104-4318
Contact: 267-425-3010
Investigator: Stephan Grupp
Children s Hospital of Philadelphia Patient Treatment
Philadelphia, Pennsylvania, 19104-4399
Contact: 267-426-9338
Investigator: Stephan Grupp
Children s Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104-4399
Investigator: Stephan Grupp
University of Pennsylvania
Philadelphia, Pennsylvania, 19104-6149
Contact: 215-898-0208
Investigator: Stephen Schuster
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Contact: 215-590-9959
Investigator: Stephan Grupp
The Childrens Hospital of Philadelphia Children's Hosp Philadelphia
Philadelphia, Pennsylvania, 19104
Contact: 215-590-7399
Investigator: Lisa Wray
The Childrens Hospital of Philadelphia Pediatric Oncology/Stem Cell T
Philadelphia, Pennsylvania, 19104
Contact: 267-426-7252
Investigator: Stephan Grupp
The Childrens Hospital of Philadelphia Regulatory
Philadelphia, Pennsylvania, 19104
Contact: 215-590-4029
Investigator: Shannon Maude
University of Pennsylvania Health System CERL080AUS90
Philadelphia, Pennsylvania, 19104
Contact: 215-615-0773
Investigator: Stephen Schuster
Pennsylvania Oncology/Hemotology Dept.ofPenn. Onc./Hem.
Philadelphia, Pennsylvania, 19106
Investigator: Stephen Schuster
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
Investigator: Hess Bryan
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Investigator: Henry C. Fung
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, 15232
Contact: 412-623-2393
Medical University of South Carolina MUSC
Charleston, South Carolina, 29425
Investigator: Jennifer Jaroscak
Prisma Health Cancer Institute
Greenville, South Carolina, 29601
Investigator: Suzanne Fanning
Avera McKennan Hospital and University Health Center
Sioux Falls, South Dakota, 57105
Investigator: Vinod Parameswaran
Methodist University Hospital Blood and Marrow Transplant
Memphis, Tennessee, 38104
Investigator: Yasser A Khaled
Texas Cancer Center ( Medical City Dallas Hospital) TX Cancer Center
Dallas, Texas, 75230
Univof Texas Southwestern Medical Center, Dept of Pediatrics
Dallas, Texas, 75235
Investigator: Samuel John
U of TX Southwestern Medical Center - SimmonsCompCancerCtr Satellite
Dallas, Texas, 75390
Contact: 214-648-1854
Investigator: Theodore Laetsch
UT Southwestern Medical Center Pediatric Hematology/Onc
Dallas, Texas, 75390
Contact: 214-648-8594
Investigator: Theodore Laetsch
UT Southwestern Medical Center UT SW Medical Ctr of Dallas
Dallas, Texas, 75390
Contact: 214-456-6742
Investigator: Theodore Laetsch
Cook Children's
Fort Worth, Texas, 76104
Investigator: Elizabeth Gordon
Investigator: Holly Pacenta, MD
Texas Children's Hospital Baylor College of Medicine
Houston, Texas, 77030-2399
Contact: 832-822-4585
Investigator: Rayne Rouce
Baylor College of Medicine
Houston, Texas, 77030
Contact: 713-790-7850
Investigator: Rayne Rouce
Houston Methodist Cancer Center Methodist Cancer Center (2)
Houston, Texas, 77030
Investigator: George Carrum
Houston Methodist Hospital
Houston, Texas, 77030
Contact: 832-470-8643
Investigator: Carlos A Ramos
MD Anderson Cancer Center/University of Texas MDACC
Houston, Texas, 77030
MD Anderson Cancer Center/University of Texas StudyCoordinator:CTKI258A2102
Houston, Texas, 77030
Contact: 713-792-1046
Investigator: Sajad Khazal
MD Anderson Cancer Center
Houston, Texas, 77030
Investigator: Jason Westin
Methodist Hospital / Methodist Cancer Center Houston Methodist Hospital
Houston, Texas, 77030
Investigator: Premal Lulla
Methodist Healthcare System
San Antonio, Texas, 78229
Contact: 210-575-3064
Investigator: Yasser A Khaled
Methodist Hospital
San Antonio, Texas, 78229
Contact: 210-575-3817
Investigator: Paul Shaughnessy
University of Utah / Huntsman Cancer Institute Huntsman Cancer Cente
Salt Lake City, Utah, 84103
Contact: 801-581-6363
Investigator: Catherine Lee
Primary Childrens Medical Center Oncology
Salt Lake City, Utah, 84113
Investigator: David Shyr
LDS Hospital
Salt Lake City, Utah, 84132
Contact: 801-581-7715
University of Virginia Health Systems UVA
Charlottesville, Virginia, 22908-0334
Contact: 434-243-8588
Investigator: Indumathy Varadarajan
VCU Health Systems, MCV
Richmond, Virginia, 23298
Investigator: Gary Simmons
Fred Hutchinson Cancer Research Center Dept. of FHCRC
Seattle, Washington, 98109
Contact: 206-667-5836
Investigator: David Maloney
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53705-3611
Contact: 608-265-6410
Investigator: Mark B Juckett
University of Wisconsin Hospital and Clinics Hematopoietic Stem Cell Lab
Madison, Wisconsin, 53792
Contact: 608-263-5003
Investigator: Vaishalee Kenkre
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792
Contact: 608-263-4900
University Wisconsin Children's Hospital
Madison, Wisconsin, 53792
Contact: 608-265-6020
Investigator: Vaishalee Kenkre
Childrens Hospital of Wisconsin
Milwaukee, Wisconsin, 53226
Investigator: Julie-An Talano
Medical College of Wisconsin Med College of WI (29)
Milwaukee, Wisconsin, 53226
Contact: 414-805-4603
Investigator: Julie-An Talano
Novartis Pharmaceuticals
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