CTL019 Out of Specification MAP for ALL or DLBCL Patients



Status:Available
Conditions:Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any
Updated:4/4/2019
Contact:Novartis Pharmaceuticals
Email:novartis.email@novartis.com
Phone:+41613241111

Use our guide to learn which trials are right for you!

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

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.

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
We found this trial at
39
sites
Aurora, Colorado 80045
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3400 N Charles St
Baltimore, Maryland 21205
410-516-8000
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
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Baltimore, MD
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1600 7th Avenue
Birmingham, Alabama 35233
(205) 638-9100
Children's Hospital of Alabama Children
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Birmingham, AL
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
University of Chicago One of the world's premier academic and research institutions, the University of...
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Chicago, IL
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
University of Michigan The University of Michigan was founded in 1817 as one of the...
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Atlanta, Georgia
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Atlanta, GA
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Atlanta, Georgia 30322
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Aurora, CO
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Austin, TX
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Boston, Massachusetts 02111
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Buffalo, New York 14203
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Cincinnati, Ohio 45229
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Cincinnati, Ohio 45236
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Cleveland, Ohio 44106
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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Dallas, Texas 75231
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Dallas, Texas 57230
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Hackensack, New Jersey 07601
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TCH
Houston, Texas 77030
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Houston, Texas 77030
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Indianapolis, IN
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Jacksonville, Florida 32224
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Los Angeles, California 90027
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9000 W Wisconsin Ave #270
Milwaukee, Wisconsin 53226
(414) 266-2000
Children's Hospital of Wisconsin Nothing matters more than our children. At Children's Hospital of Wisconsin,...
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WVU
Morgantown, West Virginia 26506
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425 East 66th Street
New York, New York 10065
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Palo Alto, California 94304
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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Philadelphia, Pennsylvania 19104
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Portland, Oregon 97201
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Portland, OR
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2000 Circle of Hope Dr
Salt Lake City, Utah 84112
(801) 585-0303
Huntsman Cancer Institute at University of Utah Huntsman Cancer Institute (HCI) is part of the...
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San Diego, California 92123
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Sioux Falls, South Dakota 57105
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Tampa, Florida 33612
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