CAR-T Treatment in Pediatric and Adult Acute Lymphoblastic Leukemia

Observational Retrospective and Prospective Multicentric Study on CAR-T Cell for the Treatment of Pediatric and Adult B-cell Acute Lymphoblastic Leukemia

The goal of this observational study is to evaluate the efficacy of the treatment with approved CAR-T cells in Italy in pediatric and adult patients with acute B-cell lymphoblastic leukemia. The main question it aims to answer is:

which is the overall response rate in pediatric and adult patients with acute B-cell lymphoblastic leukemia treated with approved CAR-T cells?

Data will be extracted from patients medical records.

This is a nationwide, prospective and retrospective, prospective, multicenter observational study that will enroll all B-ALL patients treated in Italy with commercially approved anti-CD19 CAR T cell therapy. The planned enrolment period is 24 months, followed by an additional 12-month follow-up period.

Only clinical and laboratory data produced at participating centers, as per normal clinical practice, will be collected.

Inclusion Criteria:

1. Diagnosis of ALL R/R CD19+
2. Patients are pediatric (all patients up to the age of 18) adult (all comers older than 18)
3. Prescribed treatment with Tisagenlecleucel or Brexucabtagene autoleucel as per approved AIFA criteria, or obecabtagene autoleucel - as well as other products - when available
4. Provided consent (or did not opposed) for collection and use of patient data per local regulations

Exclusion Criteria:

None

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