RecruitingNCT06070961

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

Sponsor

Fondazione Italiana Linfomi - ETS

Enrollment

56 participants

Start Date

May 7, 2024

Study Type

OBSERVATIONAL

Conditions

Follicular Lymphoma

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study examines whether COVID-19 vaccines and other vaccines continue to provide protection in patients with follicular lymphoma — a type of slow-growing blood cancer — who are undergoing chemotherapy combined with an antibody treatment (anti-CD20 therapy). The concern is that this cancer treatment may reduce vaccine effectiveness. **You may be eligible if...** - You are already enrolled in the FIL_FOLL19 clinical study for follicular lymphoma - You have received at least 3 doses of a COVID-19 vaccine - Your vaccination history (including other vaccines) is available - You are willing to have blood drawn at specific time points during your treatment **You may NOT be eligible if...** - You do not meet the criteria above - There are no additional exclusion criteria listed Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTCellular immunity vs SARS-CoV-2

Evaluation of cellular immunity vs SARS-CoV-2 by ELISpot assay

DIAGNOSTIC_TESTHumoral immunity vs SARS-CoV-2

Evaluation of Humoral immunity vs SARS-CoV-2 by ELISA assay (IgG anti-RBD and anti-N)

DIAGNOSTIC_TESTCellular immunity vs Varicella Zoster Virus

Evaluation of cellular immunity vs VZV by Enzyme-Linked immunoSPOT (ELISPOT) assay

DIAGNOSTIC_TESTHumoral immunity vs Varicella Zoster Virus

Evaluation of humoral immunity vs VZV by ELISA (VZV gE-binding IgG)

DIAGNOSTIC_TESTDiphtheria toxin-binding IgG

Evaluation of diphtheria toxin-binding IgG by ELISA assay

DIAGNOSTIC_TESTTetanus toxoid-binding IgG

Evaluation of tetanus toxoid-binding IgG by ELISA assay

DIAGNOSTIC_TESTT-cell populations and markers characterization

Characterization of T-cell populations and markers by flow cytometry

Locations(14)

Azienda Ospedaliera S.Giuseppe Moscati - S.C. Ematologia e Trapianto emopoietico

Avellino, AV, Italy

A.O. SS. Antonio e Biagio e Cesare Arrigo, S.C. Ematologia

Alessandria, IT, Italy

Nuovo Ospedale degli Infermi, SSD Ematologia

Biella, IT, Italy

ASST Grande Ospedale Metropolitano Niguarda - SC Ematologia

Milan, IT, Italy

Ospedale Maggiore Policlinico Fondazione IRCCS Ca' Granda - Ematologia

Milan, IT, Italy

A.O.U. Maggiore della Carità di Novara - S.C.D.U. Ematologia

Novara, IT, Italy

IRCCS Policlinico San Matteo - Divisione di Ematologia

Pavia, IT, Italy

Ospedale Guglielmo da Saliceto - U.O. Ematologia

Piacenza, IT, Italy

A.O.U. Città della Salute e della Scienza di Torino - S.C. Ematologia U

Torino, IT, Italy

A.O.U. Città della Salute e della Scienza di Torino - S.C. Ematologia

Torino, IT, Italy

ASST Spedali Civili - S.C. Ematologia

Brescia, Italy

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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NCT06070961

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