Trial Title:
Incidence of Severe COVID-19 Infection in Patients With CLL or B-NHL Who Received Pre-exposure Prophylaxis With Tixagevimab and Cilgavimab in Italy.
NCT ID:
NCT05803395
Condition:
Chronic Lymphocytic Leukemia
Indolent B-Cell Non-Hodgkin Lymphoma
COVID-19
Conditions: Official terms:
COVID-19
Lymphoma
Leukemia
Lymphoma, Non-Hodgkin
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, B-Cell
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Summary:
This is an observational retrospective and prospective multicenter study aimed at
describing the role of the COVID -19 prophylaxis with Tixagevimab and Cilgavimab in CLL
or indolent B-NHL patients who received first COVID-19 prophylaxis dose between March
2022 and October 2022.
Detailed description:
This is an observational retrospective and prospective multicenter study aimed at
describing the role of the COVID -19 prophylaxis with Tixagevimab and Cilgavimab in CLL
or indolent B-NHL patients.
All CLL or indolent B-cell NHL patients (follicular lymphoma, marginal zone lymphoma,
lymphoplasmacytic lymphoma) who received first COVID-19 prophylaxis dose with Tixagevimab
and Cilgavimab according to AIFA indication between March 2022 and October 2022 will be
included in the study.
Each patient will be followed for a maximum of 12 months from the first COVID-19
prophylaxis dose.
Criteria for eligibility:
Study pop:
Patients with CLL or indolent B-NHL (follicular lymphoma, marginal zone lymphoma,
lymphoplasmacytic lymphoma) who received the Tixagevimab and Cilgavimab as per Agenzia
Italiana del Farmaco (AIFA) indications.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
1. Age ≥ 18 years
2. Patient with CLL or indolent B-NHL who received the first COVID-19 prophylaxis dose
with Tixagevimab and Cilgavimab as per label indication between March 2022 and
October 2022.
3. Signed informed consent, if applicable
Exclusion Criteria:
None
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
UOC Ematologia AO Cosenza
Address:
City:
Cosenza
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Massimo Gentile
Facility:
Name:
Ematologia AOU S.Anna
Address:
City:
Ferrara
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Antonio Cuneo
Facility:
Name:
Ematologia AOU Careggi
Address:
City:
Firenze
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Alessandro Sanna
Facility:
Name:
ASST Lecco Ospedale A.Manzoni
Address:
City:
Lecco
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Clara V Viganò
Facility:
Name:
UOC Ematologia ATMO
Address:
City:
Livorno
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Rossella Riccioni
Facility:
Name:
ASST Grande Ospedale Metropolitano Niguarda
Address:
City:
Milano
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Anna Maria Frustaci
Facility:
Name:
SCDU Ematologia
Address:
City:
Novara
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Riccardo Moia
Facility:
Name:
Dipartimento Oncologico La Maddalena
Address:
City:
Palermo
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Maurizio Musso
Facility:
Name:
UOC DI ONCOEMATOLOGIA AOR Villa Sofia - Cervello
Address:
City:
Palermo
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Caterina Patti
Facility:
Name:
Ematologia Università "Sapienza" Roma
Address:
City:
Roma
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Francesca R Mauro
Facility:
Name:
IRCCS Istituto Clinico Humanitas
Address:
City:
Rozzano
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Armando Santoro
Facility:
Name:
UOC Ematologia Casa Sollievo della Sofferenza
Address:
City:
San Giovanni Rotondo
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Angelo Carella
Facility:
Name:
SCDU Ematologia e terapie cellulari AO Mauriziano
Address:
City:
Torino
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Daniela Gottardi
Facility:
Name:
Ematologia Ospedale S.Chiara
Address:
City:
Trento
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Anna Guella
Facility:
Name:
UOC ematologia ULSS2 Marca Trevigiana
Address:
City:
Treviso
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Filippo Gherlinzoni
Start date:
September 12, 2023
Completion date:
September 2024
Lead sponsor:
Agency:
Gruppo Italiano Malattie EMatologiche dell'Adulto
Agency class:
Other
Collaborator:
Agency:
Fondazione Italiana Linfomi
Agency class:
Other
Source:
Gruppo Italiano Malattie EMatologiche dell'Adulto
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05803395
