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

RECRUITINGSponsored by Novartis Pharmaceuticals
Actively Recruiting
SponsorNovartis Pharmaceuticals
Started2023-11-23
Est. completion2043-11-23
Eligibility
Age0 Years – 100 Years
Healthy vol.Accepted

Summary

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

Eligibility

Age: 0 Years – 100 YearsHealthy volunteers accepted
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.

Conditions4

Acute Lymphoblastic LeukemiaCancerDiffuse Large B-Cell LymphomaFollicular Lymphoma

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