Chronic Lymphocytic LeukemiaNCT05803395
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 of Chronic Lymphocytic Leukemia and Indolent B-Cell Non-Hodgkin Lymphoma, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 15 sites in Italy.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Lymphocytic Leukemia, Indolent B-Cell Non-Hodgkin Lymphoma, COVID-19
- How many people
- 954 participants
- Where
- 15 sitesItaly
- Study dates
- 12 Sep 2023to Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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 2022.
- Signed informed consent, if applicable
Who cannot join
- None
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Italy15 sites, 15 recruiting
- Recruiting
UOC Ematologia AO Cosenza
Cosenza
Massimo Gentile
- Recruiting
Ematologia AOU S.Anna
Ferrara
Antonio Cuneo
- Recruiting
Ematologia AOU Careggi
Florence
Alessandro Sanna
- Recruiting
ASST Lecco Ospedale A.Manzoni
Lecco
Clara V Viganò
- Recruiting
UOC Ematologia ATMO
Livorno
Rossella Riccioni
- Recruiting
ASST Grande Ospedale Metropolitano Niguarda
Milan
Anna Maria Frustaci
- Recruiting
SCDU Ematologia
Novara
Riccardo Moia
- Recruiting
Dipartimento Oncologico La Maddalena
Palermo
Maurizio Musso
- Recruiting
UOC DI ONCOEMATOLOGIA AOR Villa Sofia - Cervello
Palermo
Caterina Patti
- Recruiting
Ematologia Università "Sapienza" Roma
Roma
Francesca R Mauro
- Recruiting
IRCCS Istituto Clinico Humanitas
Rozzano
Armando Santoro
- Recruiting
UOC Ematologia Casa Sollievo della Sofferenza
San Giovanni Rotondo
Angelo Carella
- Recruiting
SCDU Ematologia e terapie cellulari AO Mauriziano
Torino
Daniela Gottardi
- Recruiting
Ematologia Ospedale S.Chiara
Trento
Anna Guella
- Recruiting
UOC ematologia ULSS2 Marca Trevigiana
Treviso
Filippo Gherlinzoni
About this study
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
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.
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell, COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2023
- Study start12 Sep 2023
- Primary completionSep 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lymphocytic LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 954 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gruppo Italiano Malattie EMatologiche dell'Adulto
- Sponsor type
- University, hospital or other
- Collaborators
- Fondazione Italiana Linfomi - ETS
- Responsible party
- Sponsor
- Investigators
- Gian Matteo Rigolin, Principal investigator, Ematologia - Azienda Ospedaliero Universitaria S.Anna di Ferrara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05803395
- Sponsor's protocol ID
- CLL2423
- Status last verified
- Nov 2023
- First submitted
- 6 Apr 2023
- Last updated
- 28 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05803395
- Acronym / sponsor ID
- CLL2423
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 954 participants (estimated)
- Lead sponsor
- Gruppo Italiano Malattie EMatologiche dell'AdultoUniversity, hospital or other
- Collaborators
- Fondazione Italiana Linfomi - ETS
- Study start
- 12 Sep 2023 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 7 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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 2022.
- Signed informed consent, if applicable
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gian Matteo Rigolin principal investigator
Ematologia - Azienda Ospedaliero Universitaria S.Anna di Ferrara
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Lymphocytic Leukemia and Indolent B-Cell Non-Hodgkin Lymphoma, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 15 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paola Fazi (0670390528, p.fazi@gimema.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess the percentage of patients who develop severe COVID-19 infection (time frame: at 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2023.