Last Update: Jun 06, 2025 Effectiveness and Safety of Tisagenlecleucel Therapy in Brazilian Patients With B-lymphocyte Malignancies: a 15-year Prospective Registry Study on Three Cohorts. ClinicalTrials.gov Identifier: [NCT05541341](https://clinicaltrials.gov/ct2/show/NCT05541341) Novartis Reference Number:CCTL019BBR02 [See if you Pre-qualify](#trial-eligibility "See if you Pre-qualify") All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. ## Study Description This will be a multicenter, national, non-interventional, prospective cohort study Eligible participants will be pediatric (\\<18 years) and adult patients (aged 18 years or older) with B-cell malignancies who have received tisagenlecleucel through the commercial setting or out-of-specification (OOS) use in Brazil. We will collect data prospectively and complement missing information with retrospective data collection, when necessary. It is anticipated that approximately 200 patients will be enrolled in the cohort over 5 years divided among the study indications. Since this is a non-interventional study, no administration of study drug or application of questionnaires will be mandated by this protocol. The study will consist of a "Pre-infusion" and a "Post infusion follow-up period" for up to 15 years post tisagenlecleucel infusion. All patients will be followed until death or last scheduled visit, whichever comes first. For the study, "pre-infusion" and "follow-up post infusion" phases are defined as: \* "Pre-infusion" will consist of the patient's information from the time of diagnosis untiljust prior to infusion with tisagenlecleucel. \* "Follow-up Post infusion" information will comprise any information from the infusionof tisagenlecleucel onwards. Condition Diffuse Large B-cell Lymphoma, Acute Lymphoblastic Leukemia, Follicular Lymphoma Overall Status Recruiting Number of Participants200 Start Date Nov 23, 2023 Gender All Age(s) 0 Years - 100 Years (Child, Adult, Older Adult) ## Interventions Other ### tisagenlecleucel Prospective observational study. There is no treatment allocation. Patients prescribed with tisagenlecleucel in the commercial setting or out-of-specification (OOS) are eligible to enroll into this 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. Brazil #### Novartis Investigative Site Recruiting Minas Gerais,Belo Horizonte,34006-059,Brazil #### Novartis Investigative Site Recruiting Salvador,Estado de Bahia,41253-190,Brazil #### Novartis Investigative Site Recruiting Curitiba,Paraná,81520-060,Brazil #### Novartis Investigative Site Recruiting São Paulo,São Paulo,01323-900,Brazil #### Novartis Investigative Site Recruiting São Paulo,São Paulo,04544-000,Brazil #### Novartis Investigative Site Recruiting São Paulo,01409-902,Brazil #### Novartis Investigative Site Recruiting São Paulo,01509-010,Brazil ## Worldwide Contacts If the location of your choosing does not feature any contact detail, please reach out using the information below. #### Novartis Pharmaceuticals Phone: [ +41613241111](tel:+41613241111) Email: