Novartis Pharmaceuticals

CTL019 Out of Specification MAP for ALL or DLBCL Patients

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
EA Type
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
Contacts: 

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

Novartis Pharmaceuticals
+41613241111

Novartis Pharmaceuticals
EA 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
Disclaimer:
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