CAR-T Treatment in Pediatric and Adult 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.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

None

Treatment and study plan

Primary outcomes

Overall response

Time frame: 12 months

Rate of patients that obatain a response

Study contacts

Contact information is provided by the study sponsor or research team.

Enrico Crea

CONTACT

[email protected]

+390670390514

Paola Fazi

CONTACT

[email protected]

+39 0670390528

Sponsors and collaborators

Lead sponsor

Gruppo Italiano Malattie EMatologiche dell'Adulto

Other

Registry information

Official study title

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

Important dates

Study start: 2026
Primary completion: 2029
Study completion: 2029
First posted: Jun 3, 2026
Registry last updated: Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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