Follows CAR-T cell therapy in adults with lymphoma or leukemia
Observes how CAR-T cells expand and persist in adults with lymphoma or leukemia.
Key facts
- Who runs it
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
- Where
- Brescia, ItalySee the site
- Trial code
- Registry title
- Bio-CAR-T BS Study
- Status
- Recruiting
- People taking part
- 45 people, planned
- Started
- 26 Apr 2022
- Expected to end
- 31 Dec 2026
- Type of study
- Observational
- Record updated
- 30 April 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for people with B-cell ALL, DLBCL or PMBCL whose cancer came back or did not respond after two lines of treatment and who are going to have CAR-T cell therapy.
- Age
- B-cell ALL: up to 25 years. DLBCL and PMBCL: 18 to 70 years.
- Sex
- All sexes can join.
- Disease stage
- B-cell ALL, DLBCL or PMBCL that came back or did not respond (relapsed/refractory) after two lines of treatment. Performance status 0 or 1. Life expectancy of at least 3 months.
- Earlier treatment
- Two lines of treatment before, which did not work or after which the disease came back.
Main reasons for not taking part
- Active or uncontrolled infection
- Blood clot (thrombo-embolism) within the last 6 months
- Clinically relevant other illnesses, for example some heart, nerve or immune disorders
- Performance status above 1
- Life expectancy under 3 months
The registry criteria, word for word
Show all 15 criteriaShow less
Who can take part
- 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
Who cannot take part
- Active or uncontrolled infections
- 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)
- Patients with B-cell-ALL > 25 years
- Patients with DLBCL <18 or >70 years
- Patients with PMBCL <18 or >70 years
- Performance status > 1
- Thrombo-embolisms within the last 6 months
- Life expectancy < 3 months
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Where in Italy
- ASST Spedali Civili di BresciaBrescia, ItalyContact: Domenico Russo, MDTaking people
About the trial
What the trial wants to find out
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.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Bio-CAR-T Study on Pre and Post-infusion CAR-T Cell Therapy
- Plain-language title
- Follows CAR-T cell therapy in adults with lymphoma or leukemiaGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT05366569, who can take part
- Record updated
- 30 April 2026