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 |
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.
(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.
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
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Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
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Children's Hospital of Alabama Children
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University of Chicago One of the world's premier academic and research institutions, the University of...
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University of Michigan The University of Michigan was founded in 1817 as one of the...
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Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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Indianapolis, Indiana 46202
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9000 W Wisconsin Ave #270
Milwaukee, Wisconsin 53226
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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Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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2000 Circle of Hope Dr
Salt Lake City, Utah 84112
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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