Effectiveness and Safety of Tisagenlecleucel Therapy in Brazilian Patients With B-lymphocyte Malignancies

Novartis

Status: Enrolling

Conditions: Follicular Lymphoma; Diffuse Large B-cell Lymphoma; Acute Lymphoblastic Leukemia

Treatments: Other: tisagenlecleucel

Study type: Observational

Funder types: Industry

Identifiers

NCT05541341

CCTL019BBR02

Details and patient eligibility

About

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

Full description

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.

Enrollment: 200 estimated patients

Sex: All

Ages: Under 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design

200 participants in 3 patient groups

Acute Lymphoblastic Leukemia (ALL)

Description:

Children/young adult patients with relapsed/refractory B-cell acute lymphoblastic leukemia who received tisagenlecleucel infusion

Treatment:

Other: tisagenlecleucel

Diffuse Large B-cell Lymphoma (DLBCL)

Description:

Adult patients with relapsed/refractory Diffuse Large B-cell Lymphoma who received tisagenlecleucel infusion

Treatment:

Other: tisagenlecleucel

Follicular Lymphoma (FL)

Description:

Patients of any gender aged 18 year or older, with relapsed/refractory Follicular Lymphoma who received tisagenlecleucel infusion.

Treatment:

Other: tisagenlecleucel