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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

NCT06070961 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 56

Last updated 2025-06-29

No results posted yet for this 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.

Conditions

Interventions

DIAGNOSTIC_TEST

Cellular immunity vs SARS-CoV-2

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

DIAGNOSTIC_TEST

Humoral immunity vs SARS-CoV-2

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

DIAGNOSTIC_TEST

Cellular immunity vs Varicella Zoster Virus

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

DIAGNOSTIC_TEST

Humoral immunity vs Varicella Zoster Virus

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

DIAGNOSTIC_TEST

Diphtheria toxin-binding IgG

Evaluation of diphtheria toxin-binding IgG by ELISA assay

DIAGNOSTIC_TEST

Tetanus toxoid-binding IgG

Evaluation of tetanus toxoid-binding IgG by ELISA assay

DIAGNOSTIC_TEST

T-cell populations and markers characterization

Characterization of T-cell populations and markers by flow cytometry

Sponsors & Collaborators

  • Fondazione Italiana Linfomi - ETS

    lead OTHER

Principal Investigators

  • Michele Merli, MD · U.O.C Ematologia, Ospedale di Circolo, Varese

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-07
Primary Completion
2027-05-31
Completion
2027-05-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06070961 on ClinicalTrials.gov