NCT05541341 Effectiveness and Safety of Tisagenlecleucel Therapy in Brazilian Patients With B-lymphocyte Malignancies
| NCT ID | NCT05541341 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Novartis Pharmaceuticals |
| Condition | Diffuse Large B-cell Lymphoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2023-11-23 |
| Primary Completion | 2043-11-23 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2023-11-23 with a primary completion date of 2043-11-23.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This will be a multicenter, national, non-interventional, prospective cohort study
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.
Contact & Investigator
Novartis Pharmaceuticals
STUDY DIRECTOR
Novartis Pharmaceuticals
Frequently Asked Questions
Who can join the NCT05541341 clinical trial?
This trial is open to participants of all sexes, aged 0 Years or older, up to 100 Years, studying Diffuse Large B-cell Lymphoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05541341 currently recruiting?
Yes, NCT05541341 is actively recruiting participants. Contact the research team at novartis.email@novartis.com for enrollment information.
Where is the NCT05541341 trial being conducted?
This trial is being conducted at Minas Gerais, Brazil, Salvador, Brazil, Curitiba, Brazil, São Paulo, Brazil and 3 additional locations.
Who is sponsoring the NCT05541341 clinical trial?
NCT05541341 is sponsored by Novartis Pharmaceuticals. The principal investigator is Novartis Pharmaceuticals at Novartis Pharmaceuticals. The trial plans to enroll 200 participants.