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

NCT ID: NCT05541341

Last Updated: 2025-06-06

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-11-23
• Study Completion Date: 2043-11-23

Brief Summary

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

Detailed 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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

Acute Lymphoblastic Leukemia (ALL)

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

tisagenlecleucel

Intervention Type: OTHER

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

Diffuse Large B-cell Lymphoma (DLBCL)

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

tisagenlecleucel

Intervention Type: OTHER

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

Follicular Lymphoma (FL)

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

tisagenlecleucel

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 0 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Novartis Investigative Site

Minas Gerais, Belo Horizonte, Brazil

Site Status: RECRUITING

Novartis Investigative Site

Salvador, Estado de Bahia, Brazil

Site Status: RECRUITING

Novartis Investigative Site

Curitiba, Paraná, Brazil

Site Status: RECRUITING

Novartis Investigative Site

São Paulo, São Paulo, Brazil

Site Status: RECRUITING

Novartis Investigative Site

São Paulo, São Paulo, Brazil

Site Status: RECRUITING

Novartis Investigative Site

São Paulo, , Brazil

Site Status: RECRUITING

Novartis Investigative Site

São Paulo, , Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Novartis Pharmaceuticals

Role: CONTACT

novartis.email@novartis.com

+41613241111

Novartis Pharmaceuticals

Role: CONTACT

Other Identifiers

CCTL019BBR02

Identifier Type: -

Identifier Source: org_study_id