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:10/05/2023
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.
For more information about this study, including how to volunteer, contact:
- Phone Number: 1-203-785-6809
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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.
- 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
- 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