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Effectiveness and Safety of Tisagenlecleucel Therapy in Brazilian Patients With B-lymphocyte Malignancies
RECRUITINGSponsored by Novartis Pharmaceuticals
Actively Recruiting
SponsorNovartis Pharmaceuticals
Started2023-11-23
Est. completion2043-11-23
Eligibility
Age0 Years – 100 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT05541341
Summary
This will be a multicenter, national, non-interventional, prospective cohort study
Eligibility
Age: 0 Years – 100 YearsHealthy volunteers accepted
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.
Conditions4
Acute Lymphoblastic LeukemiaCancerDiffuse Large B-Cell LymphomaFollicular Lymphoma
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Actively Recruiting
SponsorNovartis Pharmaceuticals
Started2023-11-23
Est. completion2043-11-23
Eligibility
Age0 Years – 100 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT05541341