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Recruiting NCT05541341

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

— Observational Diffuse Large B-cell Lymphoma Acute Lymphoblastic Leukemia Follicular Lymphoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: tisagenlecleucel.
Who it may be relevant to
Registry conditions: Diffuse Large B-cell Lymphoma, Acute Lymphoblastic Leukemia, Follicular Lymphoma. Basic parameters: 0 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Brazil
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Effectiveness and Safety of Tisagenlecleucel Therapy in Brazilian Patients With B-lymphocyte Malignancies: a 15-year Prospective Registry Study on Three Cohorts.

Overview

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.

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

Primary outcome measures

  • Overall response rate (ORR) [Time frame: Up to 15 years]
  • MRD negative overall response rate [Time frame: Up to 15 years]
  • Duration of overall response (DOR) [Time frame: Up to 15 years]
  • Relapse-free survival (RFS) [Time frame: Up to 15 years]
  • Event-free survival (EFS) for ALL patients [Time frame: Up to 15 years]
  • Progression free survival (PFS) for DLBCL patients [Time frame: Up to 15 years]
  • Overall survival (OS) [Time frame: Up to 15 years]
  • Number of ALL patients with hematologic recovery [Time frame: Up to 15 years]
Secondary outcome measures (4)
  • The type and frequency of SAEs and AE of special interest [Time frame: Up to 15 years]
  • Incidence and severity of CRS and ICANS among HTLV 1 and 2 positive versus HTLV 1 and 2 negative patients [Time frame: Up to 15 years]
  • Pregnancy rates [Time frame: Up to 15 years]
  • Number of patients with confirmed secondary malignancies diagnosis [Time frame: Up to 15 years]

Eligibility criteria

Inclusion criteria

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 criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Brazil · 7 centers
  • Novartis Investigative Site — Minas Gerais
  • Novartis Investigative Site — Salvador
  • Novartis Investigative Site — Curitiba
  • Novartis Investigative Site — São Paulo
  • Novartis Investigative Site — São Paulo
  • Novartis Investigative Site — São Paulo
  • Novartis Investigative Site — São Paulo

Identifiers

NCT: NCT05541341 · CCTL019BBR02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗