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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Retrospective and Prospective Multicentric Study on CAR-T Cell for the Treatment of Pediatric and Adult B-cell Acute Lymphoblastic Leukemia
- ClinicalTrials.gov ID
- NCT07623655
- Acronym / sponsor ID
- ALL3226
- Keywords
- CAR-T cell, pediatric, adult
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 107 participants (estimated)
- Lead sponsor
- Gruppo Italiano Malattie EMatologiche dell'AdultoUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Sep 2029 (estimated)
- Study completion
- 30 Dec 2029 (estimated)
- First posted
- 3 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- None
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall response
Time frame: 12 months
Rate of patients that obatain a response
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Federico Lussana principal investigator
Ospedale Papa Giovanni XXIII, Bergamo
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Lymphoblastic Leukemia and B-Cell Acute Lymphoblastic Leukaemia, run by Gruppo Italiano Malattie EMatologiche dell'Adulto.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Paola Fazi (+39 0670390528, p.fazi@gimema.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.