An observational study in Diffuse Large B Cell Lymphoma (DLBCL), Primary Mediastinal Large B-cell Lymphoma (PMBCL) and Acute Lymphoblastic Leukemia (ALL), sponsored by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia. Recruiting at 1 site in Italy. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-04-30.
Sponsored by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia · Observational
The aim of this Study is the evaluation of post-infusion CAR-T (Chimeric Antigen Receptor T Cell) expansion and persistence in patients with DLBCL, PMBCL and ALL undergoing CAR-T therapy; and the feasibility and efficacy of the treatment in the real life practice.
This Study is characterized by several biological sub-studies, reported as below:
1,868 studies on the registry are indexed under Lymphoma, Large B-Cell, Diffuse; 355 are open to participants now.
This study's planned enrollment of 45 is below the median of 150 across 185 observational studies indexed under Lymphoma, Large B-Cell, Diffuse.
Browse Lymphoma, Large B-Cell, Diffuse studies →Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia is the lead sponsor of 84 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Calculation is based on the primary endpoints, i.e. the persistence of the CAR-T cells and the percentage of patients infused. As the Investigator have no formal statistical hypothesis to test, sample size justification is based on estimating the 95% confidence interval for the above percentage. Based on the UOC Hematology and Pediatric Oncohematology's experience and accrual potential, the Investigators are expecting about 180 patients newly diagnosed with DLBCL or PMBCL or ALL (potential candidate to CAR-T therapy) in a 3-year time window. About 25% of these patients are expected to be eligible to CAR T-cell treatment, corresponding to 45 patients. Thus, assuming a 25% percentage of patients infused, a sample size of 45 patients will produce a two-sided 95% confidence interval ranging from 12% to 38%, with a precision (half-width of 95% confidence interval) equal to 13%.
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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Evaluation of change post-infusion CAR-T cell expansion and persistence in patients with DLBCL, PMBCL and ALL undergoing CAR-T therapy evaluated by flow-cytometry and measures by number of cells/mL
Time frame: At day +1; +3; +7; +10; +14; +21; +30; +60; +90; +120; +150; +180; +210; +240; +270; +300; +330; +360 post CAR-T cell infusion or at any time for relapse/CRS-ICANS onset (assessed up to 2 years))
Change of disease burden after CAR-T Cells treatment
Disease response will be evaluated according to Lugano criteria
Time frame: At day +30; +90; +180; 270 and + 360 post CAR-T infusion
Number of participants with treatment-related adverse events as assessed by CTCAE v 4.0 and ASTCT Consensus Grading for Cytokine Release Syndrome and Neurologic Toxicity Associated with Immune Effector Cells
CTCAE v 4.0 and ASTCT (American Society for Transplantation and Cellular Therapy) Consensus Grading for Cytokine Release Syndrome (CRS) and Neurologic Toxicity Associated with Immune Effector Cells
Time frame: At day +1; +3; +7; +10; +14; +21; +30; +60; +90; +120; +150; +180; +210; +240; +270; +300; +330; +360 post CAR-T cell infusion or at any time for relapse/CRS-ICANS onset (assessed up to 2 years)
Evaluation of disease persistence and immune recovery and neurological biomarkers after CAR-T infusion
In addiction to cytokine panel (IL-1, IL-2, IL-5, IL-6, IL-7, IL-10, IL-12, IL-15, IL-17A, GM-CSF, TNFα, IFNγ, IL-22, IL-23) as per normal clinical practice the investigators will process interleukin: IL 8, IL 1β and CP-1. Cytokine profiles will be analyzed from blood and CSF samples using Luminex platform and all the measure element will expressed in pg/mL.
Time frame: Before starting the treatment and at day +1; +3; +7; and +30 after infusion of CAR-T cell and in case of development of neurological symptoms
Evaluation of plasma level of biomarkers for ICANS neural damage and glial activation in patients who develop ICANS.
Evaluation of previously identify plasma and CSF biomarkers for inflammation,neural damage and glial activation in patients who develop ICANS. NfL and GFAP markers of neuronal injury and astroglia will be analyzed by SIMOAQuanterix, while sTREM2 (microglia activation) by Luminex, together with cytokines analysis. The unit of measurement will be pg/mL.
Time frame: Before starting the treatment and at day +1; +3; +7; and +30 after infusion of CAR-T cell and in case of development of neurological symptoms
Started Apr 2022 (actual). Primary completion is estimated for Dec 2026, 56 months after the start.
Of 52 non-industry observational studies under Lymphoma, Large B-Cell, Diffuse, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 114. This study's planned 56 months is above that.
Counting every sponsor, half of 66 studies reached it within 52 months; a quarter within 29 and three quarters within 114.
How these figures are worked out, and which studies are left out of them.
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Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia