CTL019 Out of Specification MAP for ALL or DLBCL Patients
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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.
Condition or disease
Acute Lymphoblastic Leukemia (ALL)Diffuse Large B-cell Lymphoma (DLBCL)
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.
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
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Layout table for eligibility information
Ages Eligible for Study:
1 Year to 25 Years (Child, Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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