Examining COVID-19 infection rates in patients with certain blood cancers receiving preventive treatment
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 study looks at how well a preventive treatment works in protecting patients with certain blood cancers from severe COVID-19 infections.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 954 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Gruppo Italiano Malattie EMatologiche dell'Adulto Academic / other |
| Drugs / interventions | Tixagevimab, Cilgavimab |
| Locations | 15 sites (Cosenza and 14 other locations) |
| Trial ID | NCT05803395 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the incidence of severe COVID-19 infections in patients with Chronic Lymphocytic Leukemia (CLL) or indolent B-Cell Non-Hodgkin Lymphoma (B-NHL) who received pre-exposure prophylaxis with Tixagevimab and Cilgavimab. It includes both retrospective and prospective data collection from multiple centers in Italy, focusing on patients who received their first dose of the prophylaxis between March and October 2022. Each participant will be monitored for up to 12 months following their initial treatment to assess outcomes related to COVID-19 infection.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with CLL or indolent B-NHL who received the first dose of COVID-19 prophylaxis with Tixagevimab and Cilgavimab during the specified timeframe.
Not a fit: Patients who did not receive the COVID-19 prophylaxis or those with other types of cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effectiveness of Tixagevimab and Cilgavimab in preventing severe COVID-19 in vulnerable cancer patients.
How similar studies have performed: While this study focuses on a specific patient population and treatment, similar studies have shown promising results in the use of monoclonal antibodies for COVID-19 prophylaxis in immunocompromised patients.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Cosenza and 14 other locations
- UOC Ematologia AO Cosenza — Cosenza, Italy (Recruiting)
- Ematologia AOU S.Anna — Ferrara, Italy (Recruiting)
- Ematologia AOU Careggi — Firenze, Italy (Recruiting)
- ASST Lecco Ospedale A.Manzoni — Lecco, Italy (Recruiting)
- UOC Ematologia ATMO — Livorno, Italy (Recruiting)
- ASST Grande Ospedale Metropolitano Niguarda — Milano, Italy (Recruiting)
- SCDU Ematologia — Novara, Italy (Recruiting)
- Dipartimento Oncologico La Maddalena — Palermo, Italy (Recruiting)
- UOC DI ONCOEMATOLOGIA AOR Villa Sofia - Cervello — Palermo, Italy (Recruiting)
- Ematologia Università "Sapienza" Roma — Roma, Italy (Recruiting)
- IRCCS Istituto Clinico Humanitas — Rozzano, Italy (Recruiting)
- UOC Ematologia Casa Sollievo della Sofferenza — San Giovanni Rotondo, Italy (Recruiting)
- SCDU Ematologia e terapie cellulari AO Mauriziano — Torino, Italy (Recruiting)
- Ematologia Ospedale S.Chiara — Trento, Italy (Recruiting)
- UOC ematologia ULSS2 Marca Trevigiana — Treviso, Italy (Recruiting)
Study contacts
- Principal investigator: Gian Matteo Rigolin — Ematologia - Azienda Ospedaliero Universitaria S.Anna di Ferrara
- Study coordinator: Paola Fazi
- Email: p.fazi@gimema.it
- Phone: 0670390528
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.