CAR-T Treatment in Pediatric and Adult Acute Lymphoblastic Leukemia

Gruppo Italiano Malattie EMatologiche dell'Adulto

Status: Begins enrollment in 2 months

Conditions: B-Cell Acute Lymphoblastic Leukaemia; Acute Lymphoblastic Leukemia

Study type: Observational

Funder types: Other

Identifiers

NCT07623655

ALL3226

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 107 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

-

Trial design

107 participants in 1 patient group

Patients with acute lymphoblastic leukemia treated with CAR-T cells

Description:

Pediatric and adult patients with B-cell acute lymhoblastic leukemia treated with approved CAR-T cells in Italy