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

Are you eligible to participate in this study?

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

  • Conditions: Acute Lymphoblastic Leukemia (ALL) | Diffuse Large B-cell Lymphoma (DLBCL)
  • Age: Between 0 - 100 Years
  • Gender: Male or Female

Inclusion Criteria

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

Recruitment Status

Open

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