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Phase Expanded Access

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:11/15/2022

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.

  • Start Date08/20/2019
  • End Date07/06/2023

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

Sub-Investigators

For more information about this study, contact: