Incidence of Severe COVID-19 Infection in Patients With CLL or B-NHL Who Received Pre-exposure Prophylaxis With Tixagevimab and Cilgavimab in Italy.

November 22, 2023 updated by: Gruppo Italiano Malattie EMatologiche dell'Adulto

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

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

954

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Cosenza, Italy
        • Recruiting
        • UOC Ematologia AO Cosenza
        • Contact:
          • Massimo Gentile
      • Ferrara, Italy
        • Recruiting
        • Ematologia AOU S.Anna
        • Contact:
          • Antonio Cuneo
      • Firenze, Italy
        • Recruiting
        • Ematologia AOU Careggi
        • Contact:
          • Alessandro Sanna
      • Lecco, Italy
        • Recruiting
        • ASST Lecco Ospedale A.Manzoni
        • Contact:
          • Clara V Viganò
      • Livorno, Italy
        • Recruiting
        • UOC Ematologia ATMO
        • Contact:
          • Rossella Riccioni
      • Milano, Italy
        • Recruiting
        • ASST Grande Ospedale Metropolitano Niguarda
        • Contact:
          • Anna Maria Frustaci
      • Novara, Italy
        • Recruiting
        • SCDU Ematologia
        • Contact:
          • Riccardo Moia
      • Palermo, Italy
        • Recruiting
        • Dipartimento Oncologico La Maddalena
        • Contact:
          • Maurizio Musso
      • Palermo, Italy
        • Recruiting
        • UOC DI ONCOEMATOLOGIA AOR Villa Sofia - Cervello
        • Contact:
          • Caterina Patti
      • Roma, Italy
        • Recruiting
        • Ematologia Università "Sapienza" Roma
        • Contact:
          • Francesca R Mauro
      • Rozzano, Italy
        • Recruiting
        • IRCCS Istituto Clinico Humanitas
        • Contact:
          • Armando Santoro
      • San Giovanni Rotondo, Italy
        • Recruiting
        • UOC Ematologia Casa Sollievo della Sofferenza
        • Contact:
          • Angelo Carella
      • Torino, Italy
        • Recruiting
        • SCDU Ematologia e terapie cellulari AO Mauriziano
        • Contact:
          • Daniela Gottardi
      • Trento, Italy
        • Recruiting
        • Ematologia Ospedale S.Chiara
        • Contact:
          • Anna Guella
      • Treviso, Italy
        • Recruiting
        • UOC ematologia ULSS2 Marca Trevigiana
        • Contact:
          • Filippo Gherlinzoni

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess the percentage of patients who develop severe COVID-19 infection
Time Frame: 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
at 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gruppo Italiano Malattie EMatologiche dell'Adulto

Collaborators

Fondazione Italiana Linfomi

Investigators

  • Principal Investigator: Gian Matteo Rigolin, Ematologia - Azienda Ospedaliero Universitaria S.Anna di Ferrara

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 12, 2023

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

April 6, 2023

First Submitted That Met QC Criteria

April 6, 2023

First Posted (Actual)

April 7, 2023

Study Record Updates

Last Update Posted (Actual)

November 28, 2023

Last Update Submitted That Met QC Criteria

November 22, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLL2423

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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