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

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    Enrolling By Invitation
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Updated on 19 February 2024

Summary

The purpose of this Treatment Plan is to allow access to tisagenlecleucel (CTL019) for eligible patients diagnosed with acute lymphoblastic leukemia (ALL) or large b-cell lymphomas who are unable to receive commercially manufactured product due to failure of the incoming apheresis material or outgoing product to meet the commercial specifications and where no overwhelming safety concerns has been identified for manufacture and release of the out of specification product.

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Condition acute lymphoblastic leukemia
Age 99years or below
Clinical Study Identifier03601442
Last Modified on19 February 2024

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If you need help finding a study or have any questions, please contact us at psom-ocr@pobox.upenn.edu

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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