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
Investigational Treatment Access for Blood Cancer Patients
Brief description of study.
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 of 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)
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Age: 100 years or below
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Gender: All
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
This study investigates the use of an investigational treatment for patients with certain types of blood cancer, specifically acute lymphoblastic leukemia (ALL) and diffuse large B-cell lymphoma (DLBCL). These patients have a special need due to their leukapheresis product not meeting standard specifications. Leukapheresis is a procedure to collect blood cells, and sometimes the collected cells or the final product do not meet the usual standards for commercial use. This study aims to provide access to treatment when there are no major safety concerns, despite these specifications.
Participants will receive the investigational treatment, which involves using cells that are specially prepared for the patient. This treatment is given because other options are not available or suitable for them. The study does not include patients who can have another leukapheresis or who have other treatment alternatives. The investigational treatment will be monitored closely to ensure safety and effectiveness.
- Who can participate: Participants must have a batch of the investigational treatment that is out of specification and cannot be commercially manufactured, with no other treatment options available, and must be suffering from a serious or life-threatening condition. Patients with certain infections or medical conditions, such as HIV or uncontrolled active infection, are not eligible.
- Study details: Participants will receive an investigational treatment using a product that is not commercially available but is considered safe for use. The treatment involves using a specially prepared cell product. A placebo is not used in this study.
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