NCT05541341

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

Effectiveness and Safety of Tisagenlecleucel Therapy in Brazilian Patients With B-lymphocyte Malignancies: a 15-year Prospective Registry Study on Three Cohorts.

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 0 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

This will be a multicenter, national, non-interventional, prospective cohort study

Detailed description

Eligible participants will be pediatric (\<18 years) and adult patients (aged 18 years or older) with B-cell malignancies who have received tisagenlecleucel through the commercial setting or out-of-specification (OOS) use in Brazil. We will collect data prospectively and complement missing information with retrospective data collection, when necessary. It is anticipated that approximately 200 patients will be enrolled in the cohort over 5 years divided among the study indications. Since this is a non-interventional study, no administration of study drug or application of questionnaires will be mandated by this protocol. The study will consist of a "Pre-infusion" and a "Post infusion follow-up period" for up to 15 years post tisagenlecleucel infusion. All patients will be followed until death or last scheduled visit, whichever comes first. For the study, "pre-infusion" and "follow-up post infusion" phases are defined as: * "Pre-infusion" will consist of the patient's information from the time of diagnosis untiljust prior to infusion with tisagenlecleucel. * "Follow-up Post infusion" information will comprise any information from the infusionof tisagenlecleucel onwards.

Conditions

• Diffuse Large B-cell Lymphoma
• Acute Lymphoblastic Leukemia
• Follicular Lymphoma

Interventions

Type	Name	Description
OTHER	tisagenlecleucel	Prospective observational study. There is no treatment allocation. Patients prescribed with tisagenlecleucel in the commercial setting or out-of-specification (OOS) are eligible to enroll into this study

Timeline

• Start date: 2023-11-23
• Primary completion: 2043-11-23
• Completion: 2043-11-23
• First posted: 2022-09-15
• Last updated: 2025-06-06

Locations

7 sites across 1 country: Brazil