UPCC 33418 Managed Access Program (MAP) Cohort Treatment Plan CCTL019B2003I to Provide Access for Patients With Out of Specification Leukapheresis Product and/or Out of Specification Manufactured Tisagenlecleucel (CTL019; Kymriah®)
Investigation into Access for Patients with Out of Specification Leukapheresis Product
Brief description of study
The purpose of this registration is to list Managed Access Programs (MAPs) related to CTL019, Tisagenlecleucel
Detailed description of study
CCTL019B2003I - Available - Managed Access Program (MAP) to provide access to patients with out-of-specification (OOS) leukapheresis product and/or OOS manufactured CTL019
CCTL019B2004I - Available - Managed Access Program (MAP) to provide access to reinfusion for approved indications
CCTL019A02001I - Available - Managed Access Program (MAP) to provide access to CLT019 in off-label indications
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Lymphoma, Leukemia, Off-label Indications
-
Gender: All
Inclusion Criteria:
An independent request was received from a licensed physician. The patient has a serious or life-threatening disease or condition and there is no comparable or satisfactory alternative therapy available for diagnosis, monitoring, or treatment.
The patient is not eligible or able to enrol in a clinical trial or continue participation in such trial.
There is a potential patient benefit to justify the potential risk of the treatment use, and the potential risk is not unreasonable in the context of the disease or condition to be treated.
The patient must meet any other medical criteria established by the medical experts responsible for the product or by the health authority in the country of request (as applicable).
Provision of the product will not interfere with the initiation, conduct, or completion of a Novartis clinical trial or overall development program.
Managed Access provision is allowed per local laws/regulations.
This study investigates providing access to an investigational medication for patients with serious or life-threatening conditions where standard treatments are not suitable. The study focuses on patients with out-of-specification leukapheresis products or out-of-specification manufactured cells for treatment. Leukapheresis is a procedure that involves removing white blood cells from the body, which are then modified to help fight cancer.
Study procedures involve the administration of the investigational medication to patients who cannot participate in clinical trials. The investigational medication is intended for patients who have no other treatment options available. Medical experts will evaluate the potential benefits and risks for each patient before proceeding with treatment.
- Who can participate: Patients with a serious or life-threatening disease who cannot enroll in a clinical trial may participate. They must have no alternative therapy options and meet medical criteria set by experts.
- Study details: Participants will receive the investigational medication if deemed beneficial by medical experts. The treatment is offered under specific medical criteria and local regulations.
Please choose between Voice or SMS based delivery of verification code
or