Incidence of Severe COVID-19 Infection in Patients With CLL or B-NHL Who Received Pre-exposure Prophylaxis With Tixagevimab and Cilgavimab in Italy: an Observational Study by the GIMEMA WP on Chronic Lymphoproliferative Disorders and by the FIL

Sponsor

Gruppo Italiano Malattie EMatologiche dell'Adulto (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05803395

Collaborator

Fondazione Italiana Linfomi (Other)

954

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Lymphocytic Leukemia Indolent B-Cell Non-Hodgkin Lymphoma COVID-19

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

954 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

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

Anticipated Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

Oct 1, 2023

Anticipated Study Completion Date :

Oct 1, 2023

Outcome Measures

Primary Outcome Measures

Assess the percentage of patients who develop severe COVID-19 infection [at 12 months]
Evaluation of prophylaxis efficacy in terms of percentage of patients with CLL or indolent B-NHL who develop severe COVID-19 infection, defined as COVID-19-related hospitalization or COVID -19 related death

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age ≥ 18 years
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
Signed informed consent, if applicable