Evaluation of CAR-T cell therapy in certain blood cancers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to evaluate the expansion and persistence of CAR-T cells in patients with Diffuse Large B Cell Lymphoma (DLBCL), Primary Mediastinal Large B-cell Lymphoma (PMBCL), and Acute Lymphoblastic Leukemia (ALL) after CAR-T therapy. It includes several biological sub-studies that analyze CAR-T cell dynamics, circulating extracellular vesicles, and neurological markers associated with complications like ICANS. The study employs advanced techniques such as Flow Cytometry and digital PCR for monitoring CAR-T cell subsets and aims to identify biomarkers that could predict treatment responses and complications.

Why it matters

Who can join: the full rules

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.

Where it's running

• ASST Spedali Civili di Brescia
  Brescia, Italy Recruiting

Study contacts

• Study coordinator: Domenico Russo, MD
• Email: domenico.russo@unibs.it
• Phone: 00390303996811

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.