CAR-T Treatment in Pediatric and Adult Acute Lymphoblastic Leukemia

NCT07623655 | Not Yet Recruiting

• 1 other identifier: ALL3226
• Study Type: observational
• Target: 107
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Acute Lymphoblastic Leukemia; B-Cell Acute Lymphoblastic Leukaemia

Keywords

CAR-T cell, pediatric, adult

Outcome Measures

Primary Outcomes (1)

• Overall response

  Rate of patients that obatain a response

  12 months

Study Arms (1)

Patients with acute lymphoblastic leukemia treated with CAR-T cells

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pediatric and adult patients with relapse/refractory B-cell lymphoblastic leukemia with a prescription of CAR-T cell therapy in the clinical practice

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• Gruppo Italiano Malattie EMatologiche dell'Adulto: lead

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Burkitt Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Epstein-Barr Virus Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma

Study Officials

• Federico Lussana

  Ospedale Papa Giovanni XXIII, Bergamo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paola Fazi

CONTACT

+39 0670390528; p.fazi@gimema.it

Enrico Crea

CONTACT

+390670390514; e.crea@gimema.it

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2026
• First Posted: June 3, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): December 30, 2029
• Last Updated: June 3, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share