NCT06008691 A Prospective, Observational Cohort Study on the Clinical Impact of Novel Monoclonal Antibodies in B-cell Non-Hodgkin Lymphoma in Italian Clinical Practice
| NCT ID | NCT06008691 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione Italiana Linfomi - ETS |
| Condition | Non-Hodgkin Lymphoma, B-cell |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,500 participants |
| Start Date | 2023-12-27 |
| Primary Completion | 2038-10 |
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 1,500 participants in total. It began in 2023-12-27 with a primary completion date of 2038-10.
⚠ 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
This is a prospective, observational cohort study to evaluate the clinical impact of novel Monoclonal AntiBodies (MAB) in B-cell Non-Hodgkin Lymphoma (NHL) in Italian clinical practice.
Eligibility Criteria
Inclusion Criteria: * Patients with diagnosis of B-cell NHL and need of treatment (as per guideline indications), both first-line and relapsed or refractory. * Patients aimed to be treated in indication with a "novel" MAB (alone or in combination) based on presence of an EMA clinical indication since 2020 and prescribed according to the indications for use authorized for marketing in Italy. * Signed written informed consent. Exclusion Criteria: * Being involved in a prospective interventional trial outside indication. * Patients treated outside approved indications: * 648-approved indication. * 5% AIFA support. * Compassionate use. * Age less than 18 years. * Inability to provide an informed consent.
Contact & Investigator
Marco Ladetto, Prof.
PRINCIPAL INVESTIGATOR
AO SS Antonio e Biagio e Cesare Arrigo, Alessandria
Frequently Asked Questions
Who can join the NCT06008691 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Non-Hodgkin Lymphoma, B-cell. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06008691 currently recruiting?
Yes, NCT06008691 is actively recruiting participants. Contact the research team at startup@filinf.it for enrollment information.
Where is the NCT06008691 trial being conducted?
This trial is being conducted at Viagrande, Italy, Pescia, Italy, Alessandria, Italy, Ancona, Italy and 11 additional locations.
Who is sponsoring the NCT06008691 clinical trial?
NCT06008691 is sponsored by Fondazione Italiana Linfomi - ETS. The principal investigator is Marco Ladetto, Prof. at AO SS Antonio e Biagio e Cesare Arrigo, Alessandria. The trial plans to enroll 1,500 participants.