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

Launched by NOVARTIS PHARMACEUTICALS · Sep 13, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness and safety of a treatment called tisagenlecleucel for patients in Brazil who have certain types of blood cancers, specifically Diffuse Large B-cell Lymphoma, Acute Lymphoblastic Leukemia (ALL), and Follicular Lymphoma. The study is currently recruiting participants and will involve multiple centers across the country. It looks at both children and young adults with relapsed or hard-to-treat B-cell ALL, as well as adults with relapsed Diffuse Large B-cell Lymphoma.

To be eligible for this study, participants must have received the tisagenlecleucel infusion, either in a standard or special use setting, and they must provide written consent to take part in the research. Participants can expect to have their experiences and outcomes monitored as part of this study, which aims to gather important information about how well the treatment works and its safety in real-world settings. This trial is a valuable opportunity for patients who qualify, as it contributes to understanding and improving cancer treatments for others in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• Patients eligible for inclusion in this study must meet the following criteria:
• • 1. Patients who receive tisagenlecleucel infusion in the commercial setting or out-of-specification (OOS) use, AND
• • 2. Signed informed consent must be obtained prior to participation in study, AND
• For ALL participants:
• • 3. Patients of any gender aged 0-17 years (named as pediatric) with relapsed/ refractory B-cell ALL diagnosis that received tisagenlecleucel infusion, OR
• • 4. Patients of any gender, aged 18-25 years (named as adults) - with relapsed/ refractory B-cell ALL diagnosis that received tisagenlecleucel infusion, OR
• For DBLCL and FL participants:
• • 5. Patients of any gender aged 18 years or older, who have been diagnosed with relapsed/ refractory Diffuse Large B-cell Lymphoma and received tisagenlecleucel infusion.
• Exclusion Criteria:
• • 1. Patients who did not consent to data collection.
• • 2. Patients who received tisagenlecleucel infusion as part of any interventional clinical trial.