An observational study in Acute Lymphoblastic Leukemia and B-Cell Acute Lymphoblastic Leukaemia, sponsored by Gruppo Italiano Malattie EMatologiche dell'Adulto. Not yet recruiting. Per ClinicalTrials.gov, last updated 2026-06-03.
Sponsored by Gruppo Italiano Malattie EMatologiche dell'Adulto · Observational
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.
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.
2,584 studies on the registry are indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma; 473 are open to participants now.
This study's planned enrollment of 107 is close to the median of 108 across 400 observational studies indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma.
Browse Precursor Cell Lymphoblastic Leukemia-Lymphoma studies →Gruppo Italiano Malattie EMatologiche dell'Adulto is the lead sponsor of 135 studies on the registry; 36 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Pediatric and adult patients with relapse/refractory B-cell lymphoblastic leukemia with a prescription of CAR-T cell therapy in the clinical practice
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
None
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Pediatric and adult patients with B-cell acute lymhoblastic leukemia treated with approved CAR-T cells in Italy
Overall response
Rate of patients that obatain a response
Time frame: 12 months
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Sep 2029, 36 months later.
Of 145 non-industry observational studies under Precursor Cell Lymphoblastic Leukemia-Lymphoma, half reached primary completion within 54 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 143. This study's planned 36 months is below that.
Counting every sponsor, half of 163 studies reached it within 54 months; a quarter within 24 and three quarters within 142.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Precursor Cell Lymphoblastic Leukemia-Lymphoma →
Gruppo Italiano Malattie EMatologiche dell'Adulto →