Diffuse Large B Cell Lymphoma (DLBCL)Primary Mediastinal Large B-cell Lymphoma (PMBCL)Acute Lymphoblastic Leukemia (ALL)
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria:
* Patients with B-cell-ALL (≤ 25 years) or patients with DLBCL (18-70 years) or patients with PMBCL (18-70 years) who were relapsed/refractory after two lines of treatments;
* Adequate performance status (0 or 1);
* Adequate organ function;
* No active or uncontrolled infections;
* No thrombo-embolisms within the last 6 months;
* Absence of clinically relevant co-morbidities (e.g., select cardiovascular, neurologic, or immune disorders with organ dysfunction or requiring immunosuppressive treatment in the last 24 months);
* Life expectancy of at least 3 months.
Exclusion Criteria:
* Patients with B-cell-ALL \> 25 years
* Patients with DLBCL \<18 or \>70 years
* Patients with PMBCL \<18 or \>70 years
* Performance status \> 1;
* Active or uncontrolled infections;
* Thrombo-embolisms within the last 6 months;
* Presence of clinically relevant co-morbidities (e.g., select cardiovascular, neurologic, or immune disorders with organ dysfunction or requiring immunosuppressive treatment in the last 24 months);
* Life expectancy \< 3 months.
Primary outcome measure(s)
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 — 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 — At day +30; +90; +180; 270 and + 360 post CAR-T infusion Disease response will be evaluated according to Lugano criteria
Trial sites (1)
Facility
City
Region
Status
ASST Spedali Civili di Brescia
Brescia
Italy
Recruiting
More Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia trials in Italy
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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