Study on the Safety and Effectiveness of Tisagenlecleucel Therapy in Brazilian Patients with B-cell Cancers Over 15 Years

What this Trial Is About

This research investigates the effectiveness and safety of tisagenlecleucel therapy in patients with B-cell malignancies in Brazil. It includes both children and adults with relapsed or refractory B-cell acute lymphoblastic leukemia, diffuse large B-cell lymphoma, or follicular lymphoma. The study is prospective and observational, aiming to collect long-term data over up to 15 years after treatment to understand outcomes in real-world settings. Participants include pediatric patients under 18 years with B-cell acute lymphoblastic leukemia, young adults aged 18-25 with the same diagnosis, and adults 18 or older with diffuse large B-cell lymphoma or follicular lymphoma. All patients have received tisagenlecleucel therapy either commercially or as out-of-specification use. The study does not involve administering treatment or mandating questionnaires instead, it monitors patients before and after infusion to gather comprehensive data. Participants information will be collected from diagnosis through to years after infusion, including response rates, survival, and safety events. Researchers will track overall response, relapse-free survival, and other health outcomes up to 15 years. Data will include retrospective and prospective information until death or last visit. Safety events, pregnancy rates, and secondary malignancies will also be monitored throughout the study period.

Effectiveness and Safety of Tisagenlecleucel Therapy in Brazilian Patients With B-lymphocyte Malignancies