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
Countries
Canada
United States
Locations

Children's Hospital Alabama
Birmingham, Alabama, 35233

Available

Phoenix Children's Hospital
Phoenix, Arizona, 85016

Available

Mayo AZ
Phoenix, Arizona, 85054

Available

Banner University Medical Center of Arizona -Tucson
Tucson, Arizona, 85724

Available

UCSD
La Jolla, California, 92093

Available

CHLA
Los Angeles, California, 90027

Available

UCLA
Los Angeles, California, 90095

Available

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

Available

Stanford
Palo Alto, California, 94304

Available

Rady Childrens - UCSD
San Diego, California, 92123

Available

University of Colorado - Children's Hospital Colorado
Aurora, Colorado, 80045

Available

University of Colorado
Aurora, Colorado, 80045

Available

Yale
New Haven, Connecticut, 06511

Available

Christiana Care
Wilmington, Delaware, 19801

Available

Children's National
Washington, District of Columbia, 20010

Available

University of Miami
Coral Gables, Florida, 33146

Available

Mayo
Jacksonville, Florida, 32224

Available

Johns Hopkins - All Children's Hospital
Saint Petersburg, Florida, 33701

Available

Moffitt
Tampa, Florida, 33612

Available

Northside Hospital Atlanta
Atlanta, Georgia, 30042

Available

CHOA
Atlanta, Georgia, 30322

Available

Emory
Atlanta, Georgia, 30322

Available

Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611

Available

RUSH
Chicago, Illinois, 60612

Available

University of Chicago
Chicago, Illinois, 60637

Available

Indiana University Health - Riley Hospital for Children - Indiana University
Indianapolis, Indiana, 46202

Available

University of Iowa
Iowa City, Iowa, 52242

Available

University of Kansas
Kansas City, Kansas, 66160

Available

University of Maryland
Baltimore, Maryland, 21201

Available

Johns Hopkins University
Baltimore, Maryland, 21287

Available

Dana Farber Cancer Institute - DFCI/MGH/BWH/Boston Childrens
Boston, Massachusetts, 02494

Available

Tufts
Boston, Massachusetts, 62111

Available

University of Michigan
Ann Arbor, Michigan, 48109

Available

Karmanos
Detroit, Michigan, 48201

Available

Henry Ford Health System/University Hospital
Detroit, Michigan, 48202

Available

Spectrum Health
Grand Rapids, Michigan, 49503

Available

University of Minnesota
Minneapolis, Minnesota, 55455

Available

Mayo Rochester
Rochester, Minnesota, 55905

Available

Children's Mercy Hospital
Kansas City, Missouri, 64108

Available

University of St Louis SSM Health Cardinal Glennon
Saint Louis, Missouri, 63103

Available

Washington University School of Medicine - Children's Hospital
Saint Louis, Missouri, 63110

Available

Washington University School of Medicine - Jewish Barnes
Saint Louis, Missouri, 63110

Available

University of Nebraska
Omaha, Nebraska, 68198

Available

Hackensack University Hospital
Hackensack, New Jersey, 07601

Available

CINJ/Rutgers
New Brunswick, New Jersey, 08901

Available

Roswell
Buffalo, New York, 14203

Available

Columbia University and New York and Presbyterian Hospital
New York, New York, 10032

Available

Cornell
New York, New York, 10065

Available

MSKCC
New York, New York, 10065

Available

UNC
Chapel Hill, North Carolina, 27599

Available

Duke
Durham, North Carolina, 27705

Available

Cincinnati Children's Hospital
Cincinnati, Ohio, 45229

Available

Jewish Mercy Hospital
Cincinnati, Ohio, 45236

Available

University Hospital - Case Western Reserve/Seidman Cancer Center
Cleveland, Ohio, 44106

Available

University Hospital - Rainbow Babies
Cleveland, Ohio, 44106

Available

Cleveland Clinic
Cleveland, Ohio, 44195

Available

Nationwide Children's
Columbus, Ohio, 43205

Available

The Ohio State University
Columbus, Ohio, 43210

Available

OHSU
Portland, Oregon, 97239

Available

CHOP
Philadelphia, Pennsylvania, 19104

Available

University of Pennsylvania
Philadelphia, Pennsylvania, 19104

Available

University of Pittsburgh Medical Center - Children's
Pittsburgh, Pennsylvania, 15219

Available

Medical University of South Carolina
Charleston, South Carolina, 29425

Available

Avera McKennan
Sioux Falls, South Dakota, 57105

Available

Methodist Healthcare-Memphis Hospital
Memphis, Tennessee, 38174

Available

Sarah Cannon Cancer Center - HCA/Tristar/Centennial Medical Center
Nashville, Tennessee, 37203

Available

St. David's South Medical Center Austin Texas
Austin, Texas, 78704

Available

Medical City Dallas Texas
Dallas, Texas, 57230

Available

UTSW
Dallas, Texas, 75390

Available

Houston Methodist Hospital - Baylor College of Medicine
Houston, Texas, 77030

Available

MDACC
Houston, Texas, 77030

Available

TCH
Houston, Texas, 77030

Available

Methodist San Antonio
San Antonio, Texas, 78229

Available

Huntsman Cancer Institute - University of Utah
Salt Lake City, Utah, 84112

Available

University of Virginia
Charlottesville, Virginia, 22903

Available

Virginia Commonwealth University
Richmond, Virginia, 23124

Available

Seattle Cancer Care
Seattle, Washington, 98109

Available

WVU
Morgantown, West Virginia, 26506

Available

University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792

Available

Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226

Available

Medical College of Wisconsin - Froedtert Hospital
Milwaukee, Wisconsin, 53226

Available

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