Clinical Trial 19724

Cancer Type: Malignant Hematology
Study Type: Other
NCT#: NCT03601442

Phase: N/A
Principal Investigator: Locke, Frederick

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Overview

Study Title

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

Summary

he 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.

Objective

Novartis will manufacture these cells despite being out of specification. This is called Individual patient Request

Treatments

Therapies

Medications

Inclusion 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.

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

Exclusion Criteria:

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

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