| NCT ID | NCT05366569 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia |
| Condition | Diffuse Large B Cell Lymphoma (DLBCL) |
| Study Type | OBSERVATIONAL |
| Enrollment | 45 participants |
| Start Date | 2022-04-26 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 45 participants in total. It began in 2022-04-26 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 feasibility and efficacy of the treatment in the real life practice.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05366569 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Diffuse Large B Cell Lymphoma (DLBCL). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05366569 currently recruiting?
Yes, NCT05366569 is actively recruiting participants. Contact the research team at domenico.russo@unibs.it for enrollment information.
Where is the NCT05366569 trial being conducted?
This trial is being conducted at Brescia, Italy.
Who is sponsoring the NCT05366569 clinical trial?
NCT05366569 is sponsored by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia. The trial plans to enroll 45 participants.