Overview of Primary Cardiac Lymphoma in Italy
Primary Cardiac Lymphoma: Italian Multicenter Experience
This study looks at patients in Italy with Primary Cardiac Lymphoma to see how they were treated and what their outcomes were, hoping to improve care for this rare condition.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 43 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione Italiana Linfomi - ETS Academic / other |
| Drugs / interventions | chemotherapy, rituximab, cyclophosphamide, doxorubicin, prednisone |
| Locations | 17 sites (Pagani, Salerno and 16 other locations) |
| Trial ID | NCT05819528 on ClinicalTrials.gov |
What this trial studies
This observational study aims to provide a comprehensive overview of Primary Cardiac Lymphoma (PCL) in Italy, focusing on its clinical presentation, management, and outcomes. By analyzing data from patients diagnosed with PCL between 2000 and 2020, the study seeks to address unanswered questions and shed light on aspects of the disease that are not well understood. The study will include patients treated with first-line chemoimmunotherapy regimens that include anti-CD20 monoclonal antibodies, and will gather insights that could improve clinical practice for this rare condition.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with a histologically confirmed diagnosis of Primary Cardiac Lymphoma treated with specific chemoimmunotherapy regimens.
Not a fit: Patients with secondary cardiac involvement from lymphoma or other types of lymphoma affecting the heart are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding and management of Primary Cardiac Lymphoma, potentially leading to improved patient outcomes.
How similar studies have performed: While there have been isolated case reports and reviews on Primary Cardiac Lymphoma, this study represents a novel approach to systematically analyze and document the condition in a multicenter setting.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of PCL (any histotype) defined as an extranodal lymphoma involving only the heart with possible involvement of the pericardium. * Age ≥18 years. * Diagnosis histologically confirmed. Cytofluorimetry analysis of pericardial fluid showing phenotypic features consistent with a primary cardiac lymphoma is permitted if a biopsy sample is not feasible/available for diagnosis; monoclonality is not accepted as a surrogate for diagnosis. * Date of diagnosis: from 1st January 2000 to 31st December 2020. * Only patients treated in first-line with chemoimmunotherapy regimens including an anti-CD20 monoclonal antibody are eligible for the study. * Signed written informed consent (in case of unreachable subject please see chapter 11.2) Exclusion Criteria: * Secondary cardiac involvement from lymphoma; primary mediastinal lymphoma with pericardial infiltration or other lymphomas with involvement of the pericardium/the heart by contiguity and primary effusion lymphoma are not included in this study. * Patients treated with chemotherapy regimens that did not include an anti-CD20 monoclonal antibody as first-line therapy. * Refuse to sign a written informed consent
Where this trial is running
Pagani, Salerno and 16 other locations
- Presidio ospedaliero "A. TORTORA" - U.O. Onco-ematologia — Pagani, Salerno, Italy (Not_yet_recruiting)
- AOU di Sassari - Ematologia — Sassari, Ss, Italy (Recruiting)
- Azienda Sanitaria Universitaria Giuliano Isontina (ASUGI) - SC Ematologia — Trieste, Ts, Italy (Recruiting)
- Ospedale Dell'angelo - U.O. Ematologia — Mestre, Venezia, Italy (Not_yet_recruiting)
- Azienda Ospedaliera Papa Giovanni XXIII - Ematologia — Bergamo, Italy (Recruiting)
- ASST Spedali Civili di Brescia - Ematologia — Brescia, Italy (Recruiting)
- Azienda Ospedaliero-Universitaria di Ferrara - Arcispedale Sant'Anna - Ematologia e fisiopatologia della coagulazione — Ferrara, Italy (Recruiting)
- Istituto Scientifico San Raffaele - Unitа Linfomi - Dipartimento Oncoematologia — Milan, Italy (Recruiting)
- Fondazione IRCCS Istituto Nazionale dei Tumori di Milano - Ematologia — Milan, Italy (Recruiting)
- ASST Grande Ospedale Metropolitano Niguarda - SC Ematologia — Milan, Italy (Recruiting)
- Ospedale S. Maria della Misericordia - Ematologia — Perugia, Italy (Recruiting)
- AOU Pisana - U.O. Ematologia — Pisa, Italy (Not_yet_recruiting)
- Roma - Universitа Cattolica S. Cuore - Ematologia — Roma, Italy (Not_yet_recruiting)
- AO Sant'Andrea - Ematologia — Roma, Italy (Recruiting)
- A.O. S. Maria di Terni - S.C. Oncoematologia — Terni, Italy (Not_yet_recruiting)
- A.O.U. Città della Salute e della Scienza di Torino - Ematologia Universitaria — Torino, Italy (Not_yet_recruiting)
- AOU Integrata di Verona - U.O. Ematologia — Verona, Italy (Recruiting)
Study contacts
- Principal investigator: Elisa Lucchini, MD — Trieste - Azienda Sanitaria Universitaria Giuliano Isontina (ASUGI) - SC Ematologia
- Study coordinator: Giorgio Priolo
- Email: gpriolo@filinf.it
- Phone: 0131.033175
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.