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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

  • Study HIC#:2000025634
  • Last Updated:05/08/2024

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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    For more information about this study, including how to volunteer, contact:

    Ria Syam

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    Trial Purpose and 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.

    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

    Principal Investigator

    Sub-Investigators

    For more information about this study, including how to volunteer, contact: