Acute Lymphoblastic LeukemiaNCT07623655
CAR-T Treatment in Pediatric and Adult Acute Lymphoblastic Leukemia
An observational study of Acute Lymphoblastic Leukemia and B-Cell Acute Lymphoblastic Leukaemia, run by Gruppo Italiano Malattie EMatologiche dell'Adulto.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Lymphoblastic Leukemia, B-Cell Acute Lymphoblastic Leukaemia
- How many people
- 107 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 30 Dec 2029
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- None
- -
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Keywords
- CAR-T cell, pediatric, adult
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Burkitt Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response
Rate of patients that obatain a response
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Sep 2029 (estimated)
- Study completion30 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 107 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gruppo Italiano Malattie EMatologiche dell'Adulto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Federico Lussana, Principal investigator, Ospedale Papa Giovanni XXIII, Bergamo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07623655
- Sponsor's protocol ID
- ALL3226
- Status last verified
- May 2026
- First submitted
- 29 May 2026
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No