Trial Title:
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
NCT ID:
NCT06070961
Condition:
Follicular Lymphoma
Conditions: Official terms:
COVID-19
Lymphoma
Lymphoma, Follicular
Immunoglobulin G
Conditions: Keywords:
Lymphoma
Follicular
Immunochemotherapy
FL
Vaccine
COVID19
SARS-COV-2
Tetanus
Zoster
VZV
Rituximab
obinotuzumab
FOLL19
FIL_FOLL19
diphtheria
Maintenance
Humoral
Cellular
Immunity
Induction
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
Cellular immunity vs SARS-CoV-2
Description:
Evaluation of cellular immunity vs SARS-CoV-2 by ELISpot assay
Arm group label:
Patients enrolled
Intervention type:
Diagnostic Test
Intervention name:
Humoral immunity vs SARS-CoV-2
Description:
Evaluation of Humoral immunity vs SARS-CoV-2 by ELISA assay (IgG anti-RBD and anti-N)
Arm group label:
Patients enrolled
Intervention type:
Diagnostic Test
Intervention name:
Cellular immunity vs Varicella Zoster Virus
Description:
Evaluation of cellular immunity vs VZV by Enzyme-Linked immunoSPOT (ELISPOT) assay
Arm group label:
Patients enrolled
Intervention type:
Diagnostic Test
Intervention name:
Humoral immunity vs Varicella Zoster Virus
Description:
Evaluation of humoral immunity vs VZV by ELISA (VZV gE-binding IgG)
Arm group label:
Patients enrolled
Intervention type:
Diagnostic Test
Intervention name:
Diphtheria toxin-binding IgG
Description:
Evaluation of diphtheria toxin-binding IgG by ELISA assay
Arm group label:
Patients enrolled
Intervention type:
Diagnostic Test
Intervention name:
Tetanus toxoid-binding IgG
Description:
Evaluation of tetanus toxoid-binding IgG by ELISA assay
Arm group label:
Patients enrolled
Intervention type:
Diagnostic Test
Intervention name:
T-cell populations and markers characterization
Description:
Characterization of T-cell populations and markers by flow cytometry
Arm group label:
Patients enrolled
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.
Detailed description:
Patients (pts) with follicular lymphoma (FL) were reported to be at high risk for
hospitalization and death from COVID-19 infection, especially if exposed to anti-CD20
monoclonal antibodies (mAbs)-based therapy. A large amount of studies unequivocally
demonstrated that anti-CD20 mAbs-containing therapies typically impair the development of
protective levels of neutralizing anti-spike antibodies after immunization with full
course of approved mRNA-based COVID-19 vaccines (up to 12 months after last anti-CD20
infusion). Moreover, booster doses seem to induce seroconversion only in a minority of
such pts. On the contrary, preliminary findings seem to suggest that a substantial
proportion of vaccinated pts with B-cell lymphoma (B-NHL) mount detectable
SARS-CoV-2-specific T-cell responses (as measured by assays evaluating IFN-Y secretion
after stimulation with SARS-CoV-2 peptides), independently from humoral response status.
For newly diagnosed FL pts current guidelines suggest to complete the vaccination with
booster dose(s) before treatment initiation, as anti-CD20 mAbs seems to spare
pre-established humoral immunity to COVID-19 vaccine, although data supporting this
finding are scanty.5 Furthermore, data about long term persistence of pre-established
cellular immunity in this setting are lacking, although preliminary findings in
unselected immunosuppressed pts suggest that it decline over time without significant
difference with respect to the general population.
The novel adjuvanted recombinant zoster vaccine demonstrated lower humoral immune
response in pts with B-NHL with respect to other pts, probably due to anti-CD20 therapy,
while cellular immunity was not affected, although the small number of pts requires
further investigation.
Very few data concerning persistence of immunity to childhood vaccines after
anti-CD20-based therapy are available and suggest that humoral immunity to diphtheria and
tetanus may be significantly impaired after therapy.
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 of FL
patients undergoing frontline induction immuno-chemotherapy and anti-CD20 maintenance
within the prospective FIL_FOLL19 study (NCT05058404).
After the signature of a specific informed consent, eligible patients will receive a
questionnaire evaluating vaccination history, past infection history and treatment, and
passive immune prophylaxis (e.g. tixagevimab/cilgavimab administration). A baseline blood
sample will be collected before the initiation of treatment and will be sent to the
central laboratory, where specific analyses evaluating vaccine-induced cellular and/or
humoral immunity against COVID-19, VZV, diphtheria and tetanus will be performed.
COVID-19 cellular and humoral immunity will be evaluated in all patients at all available
timepoints.
Humoral and cellular immunity for VZV will be evaluated for all patients at study entry.
In the subgroup of patients with a detectable serologic response at study entry, humoral
and cellular immunity will be also evaluated at all available later timepoints.
Humoral immunity for diphtheria and tetanus will be evaluated for all patients at study
entry. In the subgroup of patients with a detectable serologic response at study entry,
humoral immunity will be also evaluated at all available later timepoints.
T-cell immunological parameters will be evaluated at study entry and 12 months after EOI
(or early withdrawal).
Criteria for eligibility:
Study pop:
Patients affected by Follicular Lymphoma undergoing frontline induction
immuno-chemotherapy and anti-CD20 maintenance within the prospective FIL_FOLL19 study
Sampling method:
Non-Probability Sample
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
A.O. SS. Antonio e Biagio e Cesare Arrigo, S.C. Ematologia
Address:
City:
Alessandria
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Gioacchino Catania, MD
Email:
gioacchino.catania@ospedale.al.it
Investigator:
Last name:
Gioacchino Catania, MD
Email:
Principal Investigator
Facility:
Name:
Nuovo Ospedale degli Infermi, SSD Ematologia
Address:
City:
Biella
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Annarita Conconi, MD
Email:
annarita.conconi@aslbi.piemonte.it
Investigator:
Last name:
Annarita Conconi, MD
Email:
Principal Investigator
Facility:
Name:
ASST Grande Ospedale Metropolitano Niguarda - SC Ematologia
Address:
City:
Milano
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Erika Meli, MD
Email:
erika.meli@ospedaleniguarda.it
Investigator:
Last name:
Erika Meli, MD
Email:
Principal Investigator
Facility:
Name:
Ospedale Maggiore Policlinico Fondazione IRCCS Ca' Granda - Ematologia
Address:
City:
Milano
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Alessandro Noto, MD
Email:
alessandro.noto@policlinico.mi.it
Investigator:
Last name:
Alessandro Noto, MD
Email:
Principal Investigator
Facility:
Name:
A.O.U. Maggiore della Carità di Novara - S.C.D.U. Ematologia
Address:
City:
Novara
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Gloria Margiotta Casaluci, MD
Email:
gloria.margiotta@med.uniupo.it
Investigator:
Last name:
Gloria Margiotta Casaluci, MD
Email:
Principal Investigator
Facility:
Name:
IRCCS Policlinico San Matteo - Divisione di Ematologia
Address:
City:
Pavia
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Luca Arcaini, MD
Email:
luca.arcaini@unipv.it
Investigator:
Last name:
Luca Arcaini, MD
Email:
Principal Investigator
Facility:
Name:
Ospedale Guglielmo da Saliceto - U.O. Ematologia
Address:
City:
Piacenza
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Patrizia Bernuzzi, MD
Email:
p.bernuzzi@ausl.pc.it
Investigator:
Last name:
Patrizia Bernuzzi, MD
Email:
Principal Investigator
Facility:
Name:
A.O.U. Città della Salute e della Scienza di Torino - S.C. Ematologia U
Address:
City:
Torino
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Federica Cavallo, MD
Email:
f.cavallo@unito.it
Investigator:
Last name:
Federica Cavallo, MD
Email:
Principal Investigator
Facility:
Name:
A.O.U. Città della Salute e della Scienza di Torino - S.C. Ematologia
Address:
City:
Torino
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Carola Boccomini, MD
Email:
cboccomini@cittadellasalute.to.it
Investigator:
Last name:
Carola Boccomini, MD
Email:
Principal Investigator
Facility:
Name:
Ospedale di Circolo - U.O.C. Ematologia
Address:
City:
Varese
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Benedetta Bianchi, MD
Email:
benedetta.bianchi@asst-settelaghi.it
Investigator:
Last name:
Benedetta Bianchi, MD
Email:
Principal Investigator
Facility:
Name:
ASST Spedali Civili - S.C. Ematologia
Address:
City:
Brescia
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Antonella Anastasia, MD
Email:
antonella.anastasia@gmail.com
Investigator:
Last name:
Antonella Anastasia, MD
Email:
Principal Investigator
Facility:
Name:
Azienda Ospedaliera Universitaria Careggi - Unità funzionale di Ematologia
Address:
City:
Firenze
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Benedetta Sordi, MD
Email:
benedetta.sordi@unifi.it
Investigator:
Last name:
Benedetta Sordi, MD
Email:
Principal Investigator
Facility:
Name:
Azienda Unità Sanitaria Locale-IRCCS - Arcispedale Santa Maria Nuova - Ematologia
Address:
City:
Reggio Emilia
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Stefano Luminari, MD
Email:
stefano.luminari@ausl.re.it
Investigator:
Last name:
Stefano Luminari, MD
Email:
Principal Investigator
Facility:
Name:
A.O.U. Senese - U.O.C. Ematologia
Address:
City:
Siena
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Emanuele Cencini, MD
Email:
cencioema@libero.it
Investigator:
Last name:
Emanuele Cencini, MD
Email:
Principal Investigator
Start date:
May 7, 2024
Completion date:
May 2027
Lead sponsor:
Agency:
Fondazione Italiana Linfomi - ETS
Agency class:
Other
Source:
Fondazione Italiana Linfomi - ETS
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06070961
