Status:
RECRUITING
Bio-CAR-T BS Study
Lead Sponsor:
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Conditions:
Diffuse Large B Cell Lymphoma (DLBCL)
Primary Mediastinal Large B-cell Lymphoma (PMBCL)
Eligibility:
All Genders
18-70 years
Brief 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 feas...
Detailed Description
This Study is characterized by several biological sub-studies, reported as below: * Post-infusion CAR-T expansion and persistence analysis by both Flow Cytometry and digital PCR (dPCR): the aim of th...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 26 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT05366569
Start Date
April 26 2022
End Date
April 1 2026
Last Update
October 3 2025
Active Locations (1)
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1
ASST Spedali Civili di Brescia
Brescia, Italy, 25123