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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07623655

Enrollment

107

Registered

2026-06-03

Start date

2026-09-01

Completion date

2029-12-30

Last updated

2026-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Lymphoblastic Leukemia, B-Cell Acute Lymphoblastic Leukaemia

Keywords

CAR-T cell, pediatric, adult

Brief summary

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.

Detailed 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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

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 \-

Design outcomes

Primary

Measure	Time frame	Description
Overall response	12 months	Rate of patients that obatain a response

Contacts

CONTACTPaola Fazi

p.fazi@gimema.it+39 0670390528

CONTACTEnrico Crea

e.crea@gimema.it+390670390514

PRINCIPAL_INVESTIGATORFederico Lussana

Ospedale Papa Giovanni XXIII, Bergamo

Outcome results