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RecruitingNCT05803395Updated Nov 28, 2023

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 in Chronic Lymphocytic Leukemia, Indolent B-Cell Non-Hodgkin Lymphoma and COVID-19, sponsored by Gruppo Italiano Malattie EMatologiche dell'Adulto. Recruiting at 15 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-28.

Sponsored by Gruppo Italiano Malattie EMatologiche dell'Adulto · Observational

From the registry’s dates

  • Primary completion was expected by Sep 2024, 2 years 1 month ago, but the record still lists the study as recruiting.
  • Started Sep 2023; still recruiting 3 years later.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
954
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Chronic Lymphocytic Leukemia
  • Indolent B-Cell Non-Hodgkin Lymphoma
  • COVID-19
03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's planned enrollment of 954 is above the median of 261 across 3,136 observational studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Gruppo Italiano Malattie EMatologiche dell'Adulto is the lead sponsor of 132 studies on the registry; 34 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

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

Exclusion Criteria:

None

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
954 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Assess the percentage of patients who develop severe COVID-19 infection

    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

    Time frame: at 12 months

07

Study locations

15 of 15 sites recruiting
  • UOC Ematologia AO Cosenza
    Cosenza, Italy
    • Massimo Gentile · Contact
    Recruiting
  • Ematologia AOU S.Anna
    Ferrara, Italy
    • Antonio Cuneo · Contact
    Recruiting
  • Ematologia AOU Careggi
    Firenze, Italy
    • Alessandro Sanna · Contact
    Recruiting
  • ASST Lecco Ospedale A.Manzoni
    Lecco, Italy
    • Clara V Viganò · Contact
    Recruiting
  • UOC Ematologia ATMO
    Livorno, Italy
    • Rossella Riccioni · Contact
    Recruiting
  • ASST Grande Ospedale Metropolitano Niguarda
    Milano, Italy
    • Anna Maria Frustaci · Contact
    Recruiting
  • SCDU Ematologia
    Novara, Italy
    • Riccardo Moia · Contact
    Recruiting
  • Dipartimento Oncologico La Maddalena
    Palermo, Italy
    • Maurizio Musso · Contact
    Recruiting
  • UOC DI ONCOEMATOLOGIA AOR Villa Sofia - Cervello
    Palermo, Italy
    • Caterina Patti · Contact
    Recruiting
  • Ematologia Università "Sapienza" Roma
    Roma, Italy
    • Francesca R Mauro · Contact
    Recruiting
  • IRCCS Istituto Clinico Humanitas
    Rozzano, Italy
    • Armando Santoro · Contact
    Recruiting
  • UOC Ematologia Casa Sollievo della Sofferenza
    San Giovanni Rotondo, Italy
    • Angelo Carella · Contact
    Recruiting
  • SCDU Ematologia e terapie cellulari AO Mauriziano
    Torino, Italy
    • Daniela Gottardi · Contact
    Recruiting
  • Ematologia Ospedale S.Chiara
    Trento, Italy
    • Anna Guella · Contact
    Recruiting
  • UOC ematologia ULSS2 Marca Trevigiana
    Treviso, Italy
    • Filippo Gherlinzoni · Contact
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 28, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05803395
Lead sponsor
Gruppo Italiano Malattie EMatologiche dell'Adulto
Collaborators
Fondazione Italiana Linfomi
Responsible party
Sponsor
First posted
Apr 7, 2023
Start date
Sep 12, 2023
Primary completion
Sep 2024 (estimated)
Completion
Sep 2024 (estimated)
Last update
Nov 28, 2023

Study contacts

Paola Fazi
Contact
p.fazi@gimema.it
0670390528
Enrico Crea
Contact
e.crea@gimema.it
0670390514
Gian Matteo Rigolin
principal investigator · Ematologia - Azienda Ospedaliero Universitaria S.Anna di Ferrara

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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