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
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.

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.

Available
Intermediate-size Population
Acute Lymphoblastic Leukemia (ALL)
Diffuse Large B-cell Lymphoma (DLBCL)

Biological: CTL019
CTL019
Other Name: tisagenlecleucel
Other Name: Kymriah

Eligibility Criteria

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

Eligibility Gender
All
Eligibility Age
Maximum: 25 Years
Countries
Australia
Canada
United States
Locations

Banner MDACC
Gilbert, Arizona, 85234

Available

Contact: 480-256-3333

Investigator: Sajad Khazal

University of Arizona Cancer Center
Phoenix, Arizona, 85004

Available

Contact: 602-406-8262

Banner University of Arizona Medical Center
Phoenix, Arizona, 85006

Available

Contact: 520-626-3576

Investigator: Emmanuel Katsanis

Phoenix Children's Hospital
Phoenix, Arizona, 85016

Available

Contact: 602-546-0985

Phoenix Childrens Hospital
Phoenix, Arizona, 85016

Available

Contact: 602-546-0895

Banner Uni Medical Center Tucson
Tucson, Arizona, 85724

Available

Investigator: Emmanuel Katsanis

City of Hope National Medical Center Hematology&HematCellTransplant
Duarte, California, 91010 3000

Available

Contact: 626-256-4673

63469

Investigator: Leslie Popplewell

City of Hope
Duarte, California, 91010

Available

Contact: 626-930-5452

Children's Hospital Los Angeles CRFB002H2301
Los Angeles, California, 90027

Available

Contact: 323-361-8552

Investigator: Michael Pulsipher

Children's Hospital Los Angeles
Los Angeles, California, 90027

Available

Contact: 323-660-2450

Investigator: Michael Pulsipher

Childrens Hospital Los Angeles
Los Angeles, California, 90027

Available

Contact: 323-660-2450

Investigator: Michael Pulsipher

Mattel Childrens Hospital UCLA
Los Angeles, California, 90095

Available

Investigator: James Chng

University of California at Los Angeles UCLA
Los Angeles, California, 90095

Available

Contact: 310-206-2436

Investigator: Josh Sasine

Lucile Packard Children s Hospital Stanford University
Palo Alto, California, 94304

Available

Contact: 650-723-4000

Investigator: Liora Schultz

Lucile Packard Childrens Hospital
Palo Alto, California, 94304

Available

Contact: 650-736-0388

Investigator: Liora Schultz

Stanford University Medical Center
Palo Alto, California, 94304

Available

Investigator: Liora Schultz

Rady Children s Hospital Dept of Oncology
San Diego, California, 92123

Available

Contact: 858-966-5118

Investigator: Deborah Schiff

Rady Childrens Hospital
San Diego, California, 92123

Available

Contact: 858-966-7785

University of Califronia San Francisco
San Francisco, California, 94143

Available

Contact: 415-353-2305

Investigator: Charalambos Andreadis

University of California, Los Angeles
Santa Monica, California, 90904

Available

Contact: 310-582-4069

Investigator: Christopher Seet

Stanford Healthcare
Stanford, California, 94304

Available

Children's Hospital Colorado
Denver, Colorado, 80218

Available

Yale Cancer Center
New Haven, Connecticut, 06520

Available

Contact: 203-200-4363

University of Miami Hospital
Miami, Florida, 33136

Available

Advent Health
Orlando, Florida, 32804

Available

Investigator: Juan Carlos Varela
Contact: 407-543-4000

1203655

JHMI All Children s Hospital
Saint Petersburg, Florida, 33701

Available

Contact: 727-767-4150

Investigator: Gauri Sunkersett

Emory University School of Medicine Emory University (12)
Atlanta, Georgia, 30322

Available

Contact: 404-778-2214

Investigator: Pamela Allen

Emory University School of Medicine/Winship Cancer Institute Winship Cancer Center
Atlanta, Georgia, 30322

Available

Investigator: Jonathon Cohen

Emory University School of Medicine/Winship Cancer Institute
Atlanta, Georgia, 30322

Available

Contact: 404-778-5747

Investigator: Amelia Langston

Children's Healthcare of Atlanta Cellular Therapies Lab
Atlanta, Georgia, 30342

Available

Contact: 404-785-1721

Investigator: Muna Qayed

Northside Hospital
Atlanta, Georgia, 30342

Available

Contact: 404-851-5926

Augusta University Research Institution
Augusta, Georgia, 30192

Available

Contact: 706-721-6875

Investigator: Vasmi Kota

Ann and Robert H Lurie Childrens Hospital of Chicago
Chicago, Illinois, 60611

Available

Contact: 312-227-4779

Northwestern
Chicago, Illinois, 60611

Available

Contact: 312-695-6737

Investigator: Reem Karmali

University of Illinois at Chicago
Chicago, Illinois, 60612

Available

Contact: 312-355-1470

Investigator: Peter Riedell

University of CHicago Comer Children's Hospital Regulatory
Chicago, Illinois, 60637-1470

Available

Investigator: John Cunningham

University of Chicago
Chicago, Illinois, 60637

Available

Investigator: Peter Riedell

Healthwatch Plaza Research Associates
Louisville, Kentucky, 40217

Available

Contact: 502-634-3090

Investigator: Rayne Rouce

University of Maryland Medical Center UMMC
Baltimore, Maryland, 21201

Available

Contact: 410-328-8610

Investigator: Aaron Rapoport

University of Maryland Medical Center
Baltimore, Maryland, 21201

Available

Contact: 410-328-4394

Investigator: Nancy Hardy

University of Maryland
Baltimore, Maryland, 21201

Available

Investigator: Saurabh Dahiya

Johns Hopkins Outpatient Center
Baltimore, Maryland, 21287

Available

Investigator: Patrick Brown

Johns Hopkins University Hospital
Baltimore, Maryland, 21287

Available

Contact: 410-955-6776

Investigator: Patrick Brown

Tufts Medical Center
Boston, Massachusetts, 02111

Available

Contact: 617-636-7462

Investigator: Andreas Klein

Massachusetts General Hospital DF/HCC institutions
Boston, Massachusetts, 02114

Available

Contact: 617-726-8743

Investigator: Matthew Frigault

Massachusetts General Hospital
Boston, Massachusetts, 02114

Available

Contact: 617-726-8228

Investigator: Matthew Frigault

MGH Cancer Center MGH Cancer Center
Boston, Massachusetts, 02114

Available

Contact: 617-643-3715

Investigator: Matthew Frigault

MGH Cancer Center
Boston, Massachusetts, 02114

Available

Contact: 617-724-0786

Investigator: Matthew Frigault

Dana Farber Cancer Institute Dana Farber Cancer Institute
Boston, Massachusetts, 02215

Available

Contact: 617-632-5607

Investigator: Steven Margossian

Dana Farber Cancer Institute
Boston, Massachusetts, 02215

Available

Contact: 617-632-4272

Investigator: Steven Margossian

Dana-Farber Cancer Institute
Boston, Massachusetts, 02215

Available

Contact: 617-632-4295

Investigator: Caron Jacobson

University of Michigan IRB
Ann Arbor, Michigan, 48109-2800

Available

Investigator: Gregory Yanik

University of Michigan Medical Center
Ann Arbor, Michigan, 48109-5848

Available

Investigator: Mark Vander Lugt

University of Michigan Health System
Ann Arbor, Michigan, 48109

Available

Contact: 734-936-5504

Investigator: Monalisa Ghosh

Karmanos Cancer Institute
Detroit, Michigan, 48201

Available

Contact: 313-576-8994

Investigator: Abinav Deol

Moffitt Cancer Center
Detroit, Michigan, 48201

Available

Contact: 313-576-8712

Investigator: Julio Chavez

Wayne State University - Karmanos Cancer Institute
Detroit, Michigan, 48201

Available

Henry Ford Hospital Henry Ford
Detroit, Michigan, 48202 2689

Available

Contact: 313-916-8862

Investigator: Edward Peres

University of Minnesota Masonic Childrens Hospital
Minneapolis, Minnesota, 55455

Available

Contact: 612-624-9193

Investigator: Heather Stefanski

University of Minnesota
Minneapolis, Minnesota, 55455

Available

Contact: 612-625-9125

Investigator: Fiona He

Mayo CLinic
Rochester, Minnesota, 55905

Available

Contact: 507-284-2505

Investigator: Mohamed Kharfan Dabaja

WUSTL Jewish Barnes
Saint Louis, Missouri, 63110

Available

Investigator: Armin Ghobadi

Hackensack University Medical Center Hackensack UMC
Hackensack, New Jersey, 07601

Available

Contact: 201-615-7251

Investigator: Michele Donato

Hackensack University Medical Center Onc Dept
Hackensack, New Jersey, 07601

Available

Contact: 551-996-8849

Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08901

Available

Investigator: Andrew Evens

Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903

Available

Contact: 732-235-6031

Roswell Park Cancer Institute Rosewell
Buffalo, New York, 14263

Available

Contact: 716-845-4886

Investigator: Mathew Barth

Roswell Park Cancer Institute
Buffalo, New York, 14263

Available

Contact: 716-845-4485

Investigator: Philip McCarthy

Memorial Sloan Kettering
New York, New York, 10017

Available

Memorial Sloan Kettering Cancer Center MSKCC
New York, New York, 10021

Available

Contact: 646-227-2131

Investigator: Lia Palomba

Memorial Sloan Kettering Cancer Center Oncology
New York, New York, 10021

Available

Contact: 212-639-3859

Investigator: Craig Sauter

Columbia University Medical Center New York Presbyterian CUMC Research Pharmacy
New York, New York, 10032

Available

Contact: 646-317-4850

Investigator: Prakash Satwani

Columbia University Medical Center New York Presbyterian Neuroendocrine Unit
New York, New York, 10032

Available

Contact: 212-305-4921

Investigator: Prakash Satwani

Memorial Sloan Kettering Cancer Center MSKCC (9)
New York, New York, 10065

Available

Contact: 646-888-0992

Investigator: Craig Sauter

Memorial Sloan Kettering Cancer Center
New York, New York, 10065

Available

Investigator: Michael Scordo

University of North Carolina Chapel Hill Physician Office Building
Chapel Hill, North Carolina, 27514

Available

Contact: 919-843-5497

Duke University Medical Center
Durham, North Carolina, 27710

Available

Cincinnati Children s Hospital Medical Center
Cincinnati, Ohio, 45229-3039

Available

Contact: 800-344-2462

Investigator: Christine Phillips

Cincinnati Childrens Hospital
Cincinnati, Ohio, 45229

Available

Contact: 513-636-0606

Investigator: Christine Phillips

Oncology Hematology Care Inc Drug Shipment
Cincinnati, Ohio, 45242

Available

Contact: 513-751-2273

University Hospitals Cleveland Medical Center Univ. Hospitals of Cleveland
Cleveland, Ohio, 44106-5028

Available

Contact: 216-844-7164

Investigator: Kirsten Boughan

Nationwide Childrens Hospital Center
Columbus, Ohio, 43205

Available

Investigator: Rajinder Bajwa

OSU Wexner MC James CH
Columbus, Ohio, 43210

Available

Investigator: Jonathan Brammer

The Ohio State University Regulatory
Columbus, Ohio, 43210

Available

Contact: 614-366-0542

Investigator: Samantha Jaglowski

The Ohio State University Comprehensive Cancer Center Ohio State UMC James Cancer Ct
Columbus, Ohio, 43221

Available

Contact: 614-688-6563

Investigator: Samantha Jaglowski

Hematology Oncology Center, Inc.
Elyria, Ohio, 44035

Available

Contact: 440-324-0425

Investigator: Theodore Laetsch

Oregon Health Sciences University
Portland, Oregon, 97201

Available

Contact: 503-494-5431

Oregon Health and Science University
Portland, Oregon, 97239-3098

Available

Contact: 503-494-5893

OHSU
Portland, Oregon, 97239

Available

Contact: 503-494-0896

Oregon Health and Science University
Portland, Oregon, 97239

Available

Contact: 503-418-2294

Investigator: Brandon Hayes-Lattin

Childrens Hospital of Philadelphia CTRB 3006
Philadelphia, Pennsylvania, 19104 4399

Available

Contact: 215-590-5476

Investigator: Stephan Grupp

Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104-4283

Available

Contact: 215-662-6394

Investigator: Stephen Schuster

Children s Hospital of Philadelphia Patient Treatment
Philadelphia, Pennsylvania, 19104-4399

Available

Contact: 267-426-9338

Investigator: Stephan Grupp

Children s Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104-4399

Available

Investigator: Stephan Grupp

University of Pennsylvania
Philadelphia, Pennsylvania, 19104-6149

Available

Contact: 215-898-0208

Investigator: Stephen Schuster

Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104

Available

Contact: 215-590-9959

Investigator: Stephan Grupp

The Childrens Hospital of Philadelphia Children's Hosp Philadelphia
Philadelphia, Pennsylvania, 19104

Available

Contact: 215-590-7399

Investigator: Lisa Wray

The Childrens Hospital of Philadelphia Pediatric Oncology/Stem Cell T
Philadelphia, Pennsylvania, 19104

Available

Contact: 267-426-7252

Investigator: Stephan Grupp

The Childrens Hospital of Philadelphia Regulatory
Philadelphia, Pennsylvania, 19104

Available

Contact: 215-590-4029

Investigator: Shannon Maude

University of Pennsylvania Health System CERL080AUS90
Philadelphia, Pennsylvania, 19104

Available

Contact: 215-615-0773

Investigator: Stephen Schuster

Pennsylvania Oncology/Hemotology Dept.ofPenn. Onc./Hem.
Philadelphia, Pennsylvania, 19106

Available

Contact: 215-829-6306

138

Investigator: Stephen Schuster

Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107

Available

Investigator: Hess Bryan

University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, 15232

Available

Contact: 412-623-2393

Medical University of South Carolina MUSC
Charleston, South Carolina, 29425

Available

Investigator: Jennifer Jaroscak

Avera McKennan Hospital and University Health Center
Sioux Falls, South Dakota, 57105

Available

Investigator: Vinod Parameswaran

Methodist University Hospital Blood and Marrow Transplant
Memphis, Tennessee, 38104

Available

Investigator: Yasser A Khaled

Texas Cancer Center ( Medical City Dallas Hospital) TX Cancer Center
Dallas, Texas, 75230

Available

Univof Texas Southwestern Medical Center, Dept of Pediatrics
Dallas, Texas, 75235

Available

Investigator: Samuel John

U of TX Southwestern Medical Center - SimmonsCompCancerCtr Satellite
Dallas, Texas, 75390

Available

Contact: 214-648-1854

Investigator: Theodore Laetsch

UT Southwestern Medical Center UT SW Medical Ctr of Dallas
Dallas, Texas, 75390

Available

Contact: 214-456-6742

Investigator: Theodore Laetsch

Texas Children's Hospital Baylor College of Medicine
Houston, Texas, 77030-2399

Available

Contact: 832-822-4585

Investigator: Rayne Rouce

Baylor College of Medicine
Houston, Texas, 77030

Available

Contact: 713-790-7850

Investigator: Rayne Rouce

Houston Methodist Cancer Center Methodist Cancer Center (2)
Houston, Texas, 77030

Available

Investigator: George Carrum

Houston Methodist Hospital
Houston, Texas, 77030

Available

Contact: 832-470-8643

Investigator: Carlos A Ramos

MD Anderson Cancer Center/University of Texas MDACC
Houston, Texas, 77030

Available

MD Anderson Cancer Center/University of Texas StudyCoordinator:CTKI258A2102
Houston, Texas, 77030

Available

Contact: 713-792-1046

Investigator: Sajad Khazal

MD Anderson Cancer Center
Houston, Texas, 77030

Available

Investigator: Jason Westin

Methodist Hospital / Methodist Cancer Center Houston Methodist Hospital
Houston, Texas, 77030

Available

Investigator: Premal Lulla

Methodist Healthcare System
San Antonio, Texas, 78229

Available

Contact: 210-575-3064

Investigator: Yasser A Khaled

Methodist Hospital
San Antonio, Texas, 78229

Available

Contact: 210-575-3817

Investigator: Paul Shaughnessy

University of Utah / Huntsman Cancer Institute Huntsman Cancer Center
Salt Lake City, Utah, 84103

Available

Contact: 801-581-6363

Investigator: Catherine Lee

Primary Childrens Medical Center Oncology
Salt Lake City, Utah, 84113

Available

Investigator: David Shyr

LDS Hospital
Salt Lake City, Utah, 84132

Available

Contact: 801-581-7715

University of Virginia Health Systems UVA
Charlottesville, Virginia, 22908-0334

Available

Contact: 434-243-8588

Investigator: Indumathy Varadarajan

VCU Health Systems, MCV
Richmond, Virginia, 23298

Available

Investigator: Gary Simmons

Fred Hutchinson Cancer Research Center Dept. of FHCRC
Seattle, Washington, 98109

Available

Contact: 206-667-5836

Investigator: David Maloney

University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53705-3611

Available

Contact: 608-265-6410

Investigator: Mark B Juckett

University of Wisconsin Hospital and Clinics Hematopoietic Stem Cell Lab
Madison, Wisconsin, 53792

Available

Contact: 608-263-5003

Investigator: Vaishalee Kenkre

University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792

Available

Contact: 608-263-4900

University Wisconsin Children's Hospital
Madison, Wisconsin, 53792

Available

Contact: 608-265-6020

Investigator: Vaishalee Kenkre

Childrens Hospital of Wisconsin
Milwaukee, Wisconsin, 53226

Available

Investigator: Julie Talano

Medical College of Wisconsin Med College of WI (29)
Milwaukee, Wisconsin, 53226

Available

Contact: 414-805-4603

Investigator: Julie Talano

Contacts

Novartis Pharmaceuticals
1-888-669-6682
novartis.email@novartis.com

Novartis Pharmaceuticals
+41613241111

Novartis Pharmaceuticals
NCT Number
Keywords
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
MeSH Terms
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Intervention Name
CTL019