Overview of Primary Cardiac Lymphoma in Italy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Azienda Ospedaliera Papa Giovanni XXIII - Ematologia
  Bergamo, Bergamo, Italy Recruiting
• ASST Spedali Civili di Brescia - Ematologia
  Brescia, Brescia, Italy Recruiting
• Azienda Ospedaliero-Universitaria di Ferrara - Arcispedale Sant'Anna - Ematologia e fisiopatologia della coagulazione
  Ferrara, Ferrara, Italy Recruiting
• Istituto Scientifico San Raffaele - Unitа Linfomi - Dipartimento Oncoematologia
  Milan, Milano, Italy Recruiting
• Fondazione IRCCS Istituto Nazionale dei Tumori di Milano - Ematologia
  Milan, Milano, Italy Recruiting
• ASST Grande Ospedale Metropolitano Niguarda - SC Ematologia
  Milan, Milano, 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.