RecruitingNCT05541341

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.

Sponsor

Novartis Pharmaceuticals

Enrollment

200 participants

Start Date

Nov 23, 2023

Study Type

OBSERVATIONAL

Conditions

Diffuse Large B Cell Lymphoma Acute Lymphoblastic Leukemia Follicular Lymphoma

Summary

This will be a multicenter, national, non-interventional, prospective cohort study

Eligibility

Min Age: 0 YearsMax Age: 100 Years

Inclusion Criteria8

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.

Exclusion Criteria2

Patients who did not consent to data collection.
Patients who received tisagenlecleucel infusion as part of any interventional clinical trial.

Interventions

OTHERtisagenlecleucel

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