Clinical trial · Observational
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.
NCT05541341CI-TRIAL-00090696recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This will be a multicenter, national, non-interventional, prospective cohort study
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Diffuse Large B-cell Lymphoma | Diffuse Large B-Cell Lymphoma | CURATED_BROADER | 0.80 |
| Follicular Lymphoma | Follicular Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| tisagenlecleucel | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Acute Lymphoblastic Leukemia (ALL)
- description
- Children/young adult patients with relapsed/refractory B-cell acute lymphoblastic leukemia who received tisagenlecleucel infusion
- interventionNames
- Other: tisagenlecleucel
- label
- Diffuse Large B-cell Lymphoma (DLBCL)
- description
- Adult patients with relapsed/refractory Diffuse Large B-cell Lymphoma who received tisagenlecleucel infusion
- interventionNames
- Other: tisagenlecleucel
- label
- Follicular Lymphoma (FL)
- description
- Patients of any gender aged 18 year or older, with relapsed/refractory Follicular Lymphoma who received tisagenlecleucel infusion.
- interventionNames
- Other: tisagenlecleucel
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 0 Years
- Maximum age
- 100 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.