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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

Recruiting
100 years and younger
All

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.
Study details
    Acute Lymphoblastic Leukemia (ALL)
    Diffuse Large B-cell Lymphoma (DLBCL)

TX10157

19 February 2024

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