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1 Study Matches

Managed Access Program (MAP) to provide access to CTL019, for acute lymphoblastic leukemia (ALL) or large B-cell lymphoma patients with out of specification leukapheresis product and/or manufactured tisagenlecleucel out of specification for commercial release

This study is to provide access to CTL019 for ALL or large B-cell lymphoma patients who are either out of manufactured specifications or out of specification leukapheresis product who would otherwise not be able to be treated with CTL019 due to commercial restrictions. This means these manufactured cells are not able to be used commercially and insurance will not pay or contribute to paying for the product.
Jen Petrask at jpetrask@pennstatehealth.psu.edu or 717-531-8678
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This study is NOT accepting healthy volunteers
NCT03601442
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Inclusion Criteria:
patient to be treated has a serious or life threatening disease or condition and no comparable alternative therapy is available
patient is not eligible or able to enroll in a clinical trial
potential benefit to justify potential risk of the treatment use
provision of the investigational product will not interfere with the initiation, conduct or completion of a Novartis clinical trial
access to provision of investigational product is allowed per local laws and regulations
Exclusion Criteria:
product can be commercially manufactured per the specifications
evidence of CD19 negative disease in patients with B-cell ALL
active Hepatitis B, active or latent Hepatitis C, or HIV positivity
uncontrolled active infection or inflammation
pregnant or nursing women
Cancer
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Study Locations

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Location
Hershey, PA