NCT05541341Recruiting
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.
Source: ClinicalTrials.gov · Last updated 6 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This will be a multicenter, national, non-interventional, prospective cohort study
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 200 (estimated)
- First submitted
- 13 Sept 2022
- Start date
- 23 Nov 2023
- Primary completion date
- 23 Nov 2043
- Lead sponsor
- Novartis Pharmaceuticals
- Diseases
- Acute lymphoblastic leukaemia, Diffuse large B-cell lymphoma, Follicular lymphoma, Childhood cancers
- NCT number
- NCT05541341
What you commit to
- Study type: Observational
- Planned participants: 200
- From 23 Nov 2023 to the primary completion date, 23 Nov 2043
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who received tisagenlecleucel infusion as part of any interventional clinical trial.
Other
- Patients who did not consent to data collection.
Who the study is looking for
- 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.
Age in the registry: 0 years to 100 years · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Curitiba | Brazil | Recruiting |
| - Coordinator of this site? Confirm its status | Minas Gerais | Brazil | Recruiting |
| - Coordinator of this site? Confirm its status | Salvador | Brazil | Recruiting |
| - Coordinator of this site? Confirm its status | São Paulo | Brazil | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.