Evaluating COVID-19 vaccine immunity in follicular lymphoma patients undergoing treatment
Prospective Biological Study to Evaluate the Persistence of COVID-19 Vaccine and Other Vaccines'-Induced Immune Responses in Follicular Lymphoma Patients Undergoing Frontline Induction Immuno-chemotherapy and Anti-CD20 Maintenance
This study is testing how well COVID-19 vaccines work in patients with follicular lymphoma who are getting treatment to see how their immune response holds up.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 56 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione Italiana Linfomi - ETS Academic / other |
| Drugs / interventions | chemotherapy, tixagevimab, cilgavimab |
| Locations | 14 sites (Avellino, AV and 13 other locations) |
| Trial ID | NCT06070961 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the persistence of immune responses induced by COVID-19 and other vaccines in patients with follicular lymphoma who are receiving frontline immuno-chemotherapy and anti-CD20 maintenance therapy. Blood samples will be collected at various timepoints to evaluate both humoral and cellular immunity against SARS-CoV-2, Varicella Zoster Virus, and other pathogens. The study is part of a larger initiative to understand how immunosuppressive treatments affect vaccine-induced immunity in this vulnerable patient population.
Who should consider this trial
Good fit: Ideal candidates are patients with follicular lymphoma who have received at least three doses of a COVID-19 vaccine and are enrolled in the FIL_FOLL19 study.
Not a fit: Patients who have not been vaccinated against COVID-19 or those not enrolled in the FIL_FOLL19 study may not benefit from this research.
Why it matters
Potential benefit: If successful, this study could provide insights into optimizing vaccination strategies for follicular lymphoma patients, potentially improving their protection against COVID-19.
How similar studies have performed: While studies have shown varying results regarding vaccine responses in immunocompromised patients, this specific approach to evaluate long-term immunity in follicular lymphoma patients is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Enrolment in FIL\_FOLL19 study 2. Previous vaccination for COVID-19 (at least 3 doses) 3. Availability of informations about COVID-19 and other vaccines previously administered (vaccination records) 4. Willingness to comply with blood collection timepoints required for vaccination immunity evaluation 5. Signature of specific informed consent form Exclusion Criteria: None
Where this trial is running
Avellino, AV and 13 other locations
- Azienda Ospedaliera S.Giuseppe Moscati - S.C. Ematologia e Trapianto emopoietico — Avellino, Av, Italy (Recruiting)
- A.O. SS. Antonio e Biagio e Cesare Arrigo, S.C. Ematologia — Alessandria, It, Italy (Recruiting)
- Nuovo Ospedale degli Infermi, SSD Ematologia — Biella, It, Italy (Recruiting)
- ASST Grande Ospedale Metropolitano Niguarda - SC Ematologia — Milan, It, Italy (Recruiting)
- Ospedale Maggiore Policlinico Fondazione IRCCS Ca' Granda - Ematologia — Milan, It, Italy (Recruiting)
- A.O.U. Maggiore della Carità di Novara - S.C.D.U. Ematologia — Novara, It, Italy (Recruiting)
- IRCCS Policlinico San Matteo - Divisione di Ematologia — Pavia, It, Italy (Recruiting)
- Ospedale Guglielmo da Saliceto - U.O. Ematologia — Piacenza, It, Italy (Recruiting)
- A.O.U. Città della Salute e della Scienza di Torino - S.C. Ematologia U — Torino, It, Italy (Recruiting)
- A.O.U. Città della Salute e della Scienza di Torino - S.C. Ematologia — Torino, It, Italy (Recruiting)
- ASST Spedali Civili - S.C. Ematologia — Brescia, Italy (Recruiting)
- Azienda Ospedaliera Universitaria Careggi - Unità funzionale di Ematologia — Florence, Italy (Recruiting)
- Azienda Unità Sanitaria Locale-IRCCS - Arcispedale Santa Maria Nuova - Ematologia — Reggio Emilia, Italy (Recruiting)
- A.O.U. Senese - U.O.C. Ematologia — Siena, Italy (Recruiting)
Study contacts
- Principal investigator: Michele Merli, MD — U.O.C Ematologia, Ospedale di Circolo, Varese
- Study coordinator: Uffici Studi FIL
- Email: startup@filinf.it
- Phone: +390131033153
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.