Effectiveness and Safety of Tisagenlecleucel Therapy in Brazilian Patients With B-lymphocyte Malignancies
Recruiting now
Conditions studied: Diffuse Large B-cell Lymphoma, Acute Lymphoblastic Leukemia, Follicular Lymphoma
In brief
This will be a multicenter, national, non-interventional, prospective cohort study
Key facts
- Study ID
- NCT05541341
- Run by
- Novartis Pharmaceuticals
- People needed
- 200
- Starts
- 2023-11-23
- Expected to finish
- 2043-11-23
- Last updated by the study team
- 2025-06-06
Who can join
Age: any, up to 100. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients eligible for inclusion in this study must meet the following criteria:
- Patients who receive tisagenlecleucel infusion in the commercial setting or out-of-specification (OOS) use, AND
- Signed informed consent must be obtained prior to participation in study, AND
- For ALL participants:
- Patients of any gender aged 0-17 years (named as pediatric) with relapsed/ refractory B-cell ALL diagnosis that received tisagenlecleucel infusion, OR
- 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:
- 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.
You may not qualify if…
- Patients who did not consent to data collection.
- Patients who received tisagenlecleucel infusion as part of any interventional clinical trial.
Where it is running
- Novartis Investigative Site — Minas Gerais, Belo Horizonte, Brazil (enrolling)
- Novartis Investigative Site — Salvador, Estado de Bahia, Brazil (enrolling)
- Novartis Investigative Site — Curitiba, Paraná, Brazil (enrolling)
- Novartis Investigative Site — São Paulo, São Paulo, Brazil (enrolling)
- Novartis Investigative Site — São Paulo, São Paulo, Brazil (enrolling)
- Novartis Investigative Site — São Paulo, Brazil (enrolling)
- Novartis Investigative Site — São Paulo, Brazil (enrolling)
Full record on ClinicalTrials.gov
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