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
Condition(s) studied
Investigational drug(s) / intervention(s)
Cellular immunity vs SARS-CoV-2: Evaluation of cellular immunity vs SARS-CoV-2 by ELISpot assay
Humoral immunity vs SARS-CoV-2: Evaluation of Humoral immunity vs SARS-CoV-2 by ELISA assay (IgG anti-RBD and anti-N)
Cellular immunity vs Varicella Zoster Virus: Evaluation of cellular immunity vs VZV by Enzyme-Linked immunoSPOT (ELISPOT) assay
Humoral immunity vs Varicella Zoster Virus: Evaluation of humoral immunity vs VZV by ELISA (VZV gE-binding IgG)
Diphtheria toxin-binding IgG: Evaluation of diphtheria toxin-binding IgG by ELISA assay
Tetanus toxoid-binding IgG: Evaluation of tetanus toxoid-binding IgG by ELISA assay
T-cell populations and markers characterization: Characterization of T-cell populations and markers by flow cytometry
Study summary
This is a prospective biological study evaluating the persistence of COVID-19 vaccine and other vaccines' (zoster, diphtheria and tetanus)-induced immunity in a subgroup patient affected by Follicular Lymphoma requiring treatment undergoing frontline induction immuno-chemotherapy and anti-CD20 maintenance within the prospective FIL\_FOLL19 study (NCT05058404).
Blood samples from patients will be collected before and at planned timepoints during treatment to evaluate humoral and cellular immunity against SARS-COV-2, VZV, tetanus and diphtheria and T-cell markers characterization.
Eligibility
Primary outcome measure(s)
- Rate of patients with persistence of cell-mediated immunity induced by COVID-19 approved vaccines (at least three doses) after standard induction immuno-chemotherapy. — At the end of induction therapy (EOI) - About 8 months from treatment start
Proportion of patients with laboratory parameters of vaccine-induced cellular immunity against SARS-CoV-2 (by ELISpot assay) at EOI (after induction immuno-chemotherapy) vs proportion at baseline
Trial sites (14)
| Facility | City | Region | Status |
|---|---|---|---|
| Azienda Ospedaliera S.Giuseppe Moscati - S.C. Ematologia e Trapianto emopoietico | Avellino | AV | |
| A.O. SS. Antonio e Biagio e Cesare Arrigo, S.C. Ematologia | Alessandria | IT | |
| Nuovo Ospedale degli Infermi, SSD Ematologia | Biella | IT | |
| ASST Grande Ospedale Metropolitano Niguarda - SC Ematologia | Milan | IT | |
| Ospedale Maggiore Policlinico Fondazione IRCCS Ca' Granda - Ematologia | Milan | IT | |
| A.O.U. Maggiore della Carità di Novara - S.C.D.U. Ematologia | Novara | IT | |
| IRCCS Policlinico San Matteo - Divisione di Ematologia | Pavia | IT | |
| Ospedale Guglielmo da Saliceto - U.O. Ematologia | Piacenza | IT | |
| A.O.U. Città della Salute e della Scienza di Torino - S.C. Ematologia U | Torino | IT | |
| A.O.U. Città della Salute e della Scienza di Torino - S.C. Ematologia | Torino | IT | |
| Ospedale delle Croci, Ematologia | Ravenna | RA | |
| Azienda Ospedaliera Universitaria Careggi - Unità funzionale di Ematologia | Florence | Italy | |
| Azienda Unità Sanitaria Locale-IRCCS - Arcispedale Santa Maria Nuova - Ematologia | Reggio Emilia | Italy | |
| A.O.U. Senese - U.O.C. Ematologia | Siena | Italy |
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06070961 on ClinicalTrials.gov ↗ ← All trials in Italy