Primary Cardiac Lymphoma: Italian Multicenter Experience

NCT05819528 | Recruiting

• 1 other identifier: FIL_Lympho-Heart
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 17

Brief Summary

The rationale of this study is to provide an overview on PCL (Primary Cardiac Lymphoma) in Italy, trying to shed light on unknown aspects of the disease and on unanswered questions about its management that could be helpful in clinical practice.

Conditions

Primary Cardiac Lymphoma

Keywords

PCL

Outcome Measures

Primary Outcomes (1)

• Overall survival (OS)

  Overall survival, the percentage of patients alive of the cohort (patients with cardiac lymphoma diagnosed from 01/01/2000 to 31/12/2020).

  The endpoint will be evaluated within 2 months from the end of data collection. The end of data collection is scheduled within the Q4 (fourth quarter) of 2023.

Secondary Outcomes (7)

• Complete remission (CR)

  The endpoint will be evaluated within 2 months from the end of data collection. The end of data collection is scheduled within the Q4 (fourth quarter) of 2023.

• Overall Response Rate (ORR)

  The endpoint will be evaluated within 2 months from the end of data collection. The end of data collection is scheduled within the Q4 (fourth quarter) of 2023.

• Progression-Fee Survival (PFS)

  The endpoint will be evaluated within 2 months from the end of data collection. The end of data collection is scheduled within the Q4 (fourth quarter) of 2023.

• Frequencies of the type of chemo(immuno)therapy and of the number of cycles received as first and second line.

  The endpoint will be evaluated within 2 months from the end of data collection. The end of data collection is scheduled within the Q4 (fourth quarter) of 2023.

• Frequencies of the type of Central Nervous System (CNS) prophylaxis

  The endpoint will be evaluated within 2 months from the end of data collection. The end of data collection is scheduled within the Q4 (fourth quarter) of 2023.

Study Arms (1)

Patients enrolled

Patients with a diagnosis primary cardiac lymphoma. The study includes patients with PCL diagnosed from 01/01/2000 to 31/12/2020.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient affected by primary cardiac lymphoma from 1st January 2000 to 31st December 2020.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione Italiana Linfomi - ETS: lead

Study Sites (17)

Presidio ospedaliero "A. TORTORA" - U.O. Onco-ematologia

Pagani, Salerno, 84016, Italy

NOT YET RECRUITING

AOU di Sassari - Ematologia

Sassari, SS, 07100, Italy

RECRUITING

Azienda Sanitaria Universitaria Giuliano Isontina (ASUGI) - SC Ematologia

Trieste, TS, 34121, Italy

RECRUITING

Ospedale Dell'angelo - U.O. Ematologia

Mestre, Venezia, 30174, Italy

NOT YET RECRUITING

Azienda Ospedaliera Papa Giovanni XXIII - Ematologia

Bergamo, 24127, Italy

RECRUITING

ASST Spedali Civili di Brescia - Ematologia

Brescia, 25123, Italy

RECRUITING

Azienda Ospedaliero-Universitaria di Ferrara - Arcispedale Sant'Anna - Ematologia e fisiopatologia della coagulazione

Ferrara, 44124, Italy

RECRUITING

Istituto Scientifico San Raffaele - Unitа Linfomi - Dipartimento Oncoematologia

Milan, 20132, Italy

RECRUITING

Fondazione IRCCS Istituto Nazionale dei Tumori di Milano - Ematologia

Milan, 20133, Italy

RECRUITING

ASST Grande Ospedale Metropolitano Niguarda - SC Ematologia

Milan, 20162, Italy

RECRUITING

Ospedale S. Maria della Misericordia - Ematologia

Perugia, 06129, Italy

RECRUITING

AOU Pisana - U.O. Ematologia

Pisa, 56126, Italy

NOT YET RECRUITING

Roma - Universitа Cattolica S. Cuore - Ematologia

Roma, 00168, Italy

NOT YET RECRUITING

AO Sant'Andrea - Ematologia

Roma, 00183, Italy

RECRUITING

A.O. S. Maria di Terni - S.C. Oncoematologia

Terni, 05100, Italy

NOT YET RECRUITING

A.O.U. Città della Salute e della Scienza di Torino - Ematologia Universitaria

Torino, 10126, Italy

NOT YET RECRUITING

AOU Integrata di Verona - U.O. Ematologia

Verona, 37134, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

In order to perform pathology review, centers are requested to send all the histological and immunohistochemical slides performed at the local site for diagnosis and the block. A possible alternative to the block is 15 unstained slides. Only block and/or only unstained slides availability is not accepted.

Study Officials

• Elisa Lucchini, MD

  Trieste - Azienda Sanitaria Universitaria Giuliano Isontina (ASUGI) - SC Ematologia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giorgio Priolo

CONTACT

0131.033175; gpriolo@filinf.it

Samantha Deianira Dattoli

CONTACT

0599769914; sdattoli@filinf.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2023
• First Posted: April 19, 2023
• Study Start: October 2, 2024
• Primary Completion: April 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: January 5, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (17)