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

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

Brief description of study

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.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    acute lymphoblastic leukemia
  • Age: - 99 Years
  • Gender: All


Updated on 09 Mar 2024. Study ID: 831527
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Interested in the study

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