Evaluating the effectiveness and safety of tisagenlecleucel therapy in Brazilian patients with B-cell malignancies

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, national, non-interventional, prospective cohort study aims to assess the effectiveness and safety of tisagenlecleucel therapy in Brazilian patients diagnosed with B-lymphocyte malignancies, including Diffuse Large B-cell Lymphoma and Acute Lymphoblastic Leukemia. Eligible participants, both pediatric and adult, will have received tisagenlecleucel through commercial settings or out-of-specification use. The study will involve collecting data prospectively, with a follow-up period extending up to 15 years post-infusion, to monitor patient outcomes and safety. Approximately 200 patients are expected to be enrolled over a span of five years.

Why it matters

Who can join: the full rules

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.

Where it's running

• Novartis Investigative Site
  Minas Gerais, Belo Horizonte, Brazil Recruiting
• Novartis Investigative Site
  Salvador, Estado de Bahia, Brazil Recruiting
• Novartis Investigative Site
  Curitiba, Paraná, Brazil Recruiting
• Novartis Investigative Site
  São Paulo, São Paulo, Brazil Recruiting
• Novartis Investigative Site
  São Paulo, São Paulo, Brazil Recruiting
• Novartis Investigative Site
  São Paulo, Brazil Recruiting

Study contacts

• Study coordinator: Novartis Pharmaceuticals
• Email: novartis.email@novartis.com
• Phone: +41613241111

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.