Clinical trial NCT05803395: Incidence of Severe COVID-19 Infection in Patients With CLL or B-NHL Who Received Pre-exposure Prophylaxis With Tixagevimab and Cilgavimab in Italy.
Official title: Incidence of Severe COVID-19 Infection in Patients With Chronic Lymphocytic Leukemia or Indolent B-cell Non-Hodgkin Lymphoma Who Received Pre-exposure Prophylaxis With Tixagevimab and Cilgavimab in Italy: an Observational Study by the GIMEMA Working Party on Chronic Lymphoproliferative Disorders and by the Fondazione Italiana Linfomi
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Lymphocytic Leukemia
Indolent B-Cell Non-Hodgkin Lymphoma
COVID-19
Lead sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto
Sponsor class: OTHER
Collaborators: name: Fondazione Italiana Linfomi
First posted: 2023-04-07
Enrollment: 954
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief 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.

Eligibility 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

Primary outcomes:
measure: Assess the percentage of patients who develop severe COVID-19 infection
timeFrame: at 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cosenza
country: Italy
facility: UOC Ematologia AO Cosenza
city: Ferrara
country: Italy
facility: Ematologia AOU S.Anna
city: Firenze
country: Italy
facility: Ematologia AOU Careggi
city: Lecco
country: Italy
facility: ASST Lecco Ospedale A.Manzoni
city: Livorno
country: Italy
facility: UOC Ematologia ATMO
city: Milano
country: Italy
facility: ASST Grande Ospedale Metropolitano Niguarda
city: Novara
country: Italy
facility: SCDU Ematologia
city: Palermo
country: Italy
facility: Dipartimento Oncologico La Maddalena
city: Palermo
country: Italy
facility: UOC DI ONCOEMATOLOGIA AOR Villa Sofia - Cervello
city: Roma
country: Italy
facility: Ematologia Università "Sapienza" Roma
city: Rozzano
country: Italy
facility: IRCCS Istituto Clinico Humanitas
city: San Giovanni Rotondo
country: Italy
facility: UOC Ematologia Casa Sollievo della Sofferenza
city: Torino
country: Italy
facility: SCDU Ematologia e terapie cellulari AO Mauriziano
city: Trento
country: Italy
facility: Ematologia Ospedale S.Chiara
city: Treviso
country: Italy
facility: UOC ematologia ULSS2 Marca Trevigiana
Study officials:
affiliation: Ematologia - Azienda Ospedaliero Universitaria S.Anna di Ferrara
name: Gian Matteo Rigolin
role: PRINCIPAL_INVESTIGATOR
References: