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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

Last Updated: 2023-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

954 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-12

Study Completion Date

2024-09-30

Brief Summary

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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

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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.

Conditions

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

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondazione Italiana Linfomi

UNKNOWN

Sponsor Role collaborator

Gruppo Italiano Malattie EMatologiche dell'Adulto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gian Matteo Rigolin

Role: PRINCIPAL_INVESTIGATOR

Ematologia - Azienda Ospedaliero Universitaria S.Anna di Ferrara

Locations

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UOC Ematologia AO Cosenza

Cosenza, , Italy

Site Status RECRUITING

Ematologia AOU S.Anna

Ferrara, , Italy

Site Status RECRUITING

Ematologia AOU Careggi

Florence, , Italy

Site Status RECRUITING

ASST Lecco Ospedale A.Manzoni

Lecco, , Italy

Site Status RECRUITING

UOC Ematologia ATMO

Livorno, , Italy

Site Status RECRUITING

ASST Grande Ospedale Metropolitano Niguarda

Milan, , Italy

Site Status RECRUITING

SCDU Ematologia

Novara, , Italy

Site Status RECRUITING

Dipartimento Oncologico La Maddalena

Palermo, , Italy

Site Status RECRUITING

UOC DI ONCOEMATOLOGIA AOR Villa Sofia - Cervello

Palermo, , Italy

Site Status RECRUITING

Ematologia Università "Sapienza" Roma

Roma, , Italy

Site Status RECRUITING

IRCCS Istituto Clinico Humanitas

Rozzano, , Italy

Site Status RECRUITING

UOC Ematologia Casa Sollievo della Sofferenza

San Giovanni Rotondo, , Italy

Site Status RECRUITING

SCDU Ematologia e terapie cellulari AO Mauriziano

Torino, , Italy

Site Status RECRUITING

Ematologia Ospedale S.Chiara

Trento, , Italy

Site Status RECRUITING

UOC ematologia ULSS2 Marca Trevigiana

Treviso, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Paola Fazi

Role: CONTACT

[email protected]
0670390528

Enrico Crea

Role: CONTACT

[email protected]
0670390514

Facility Contacts

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Massimo Gentile

Role: primary

Antonio Cuneo

Role: primary

Alessandro Sanna

Role: primary

Clara V Viganò

Role: primary

Rossella Riccioni

Role: primary

Anna Maria Frustaci

Role: primary

Riccardo Moia

Role: primary

Maurizio Musso

Role: primary

Caterina Patti

Role: primary

Francesca R Mauro

Role: primary

Armando Santoro

Role: primary

Angelo Carella

Role: primary

Daniela Gottardi

Role: primary

Anna Guella

Role: primary

Filippo Gherlinzoni

Role: primary

Other Identifiers

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CLL2423

Identifier Type: -

Identifier Source: org_study_id