Study Description
This will be a multicenter, national, non-interventional, prospective cohort study 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
tisagenlecleucel
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.
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