Clinical trial NCT05819528: Primary Cardiac Lymphoma: Italian Multicenter Experience
Official title: Primary Cardiac Lymphoma: Italian Multicenter Experience
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Primary Cardiac Lymphoma
Keywords: PCL
Lead sponsor: Fondazione Italiana Linfomi - ETS
Sponsor class: OTHER
First posted: 2023-04-19
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient affected by primary cardiac lymphoma from 1st January 2000 to 31st December 2020.

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.

Detailed description: Primary cardiac lymphoma (PCL), an extranodal lymphoma involving only the heart (with possible involvement of the pericardium) is a rare entity, accounting for 2% of primary cardiac tumors and 0.5% of extranodal lymphomas. It is more frequent in males; clinical presentation is predominated by cardiac symptoms. The most common histology is Diffuse Large B Cell Lymphoma (DLBCL). Being DLBCL the most frequent histology, patients are usually treated with R-CHOP (rituximab - cyclophosphamide, doxorubicin, vincristine and prednisone) or R-CHOP-like chemoimmunotherapy regimens, with an historically poor outcome, although in the last years survival rates significantly increased. Due to the rarity of this condition, isolated case reports and a few reviews have been published so far, that in most cases included a population collected in a wide period of time, heterogeneously managed both in terms of treatments received and follow-up, and who often did not strictly respect the criteria of PCL. Indeed, while some aspects of PCL are well-known, especially the ones concerning its clinical presentation, a few topics deserve more in-depth analysis. The rationale of this study is to provide an overview on PCL 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.

Eligibility 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

Primary outcomes:
measure: Overall survival (OS)
timeFrame: 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:
measure: Complete remission (CR)
timeFrame: 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.
measure: Overall Response Rate (ORR)
timeFrame: 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.
measure: Progression-Fee Survival (PFS)
timeFrame: 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.
measure: Frequencies of the type of chemo(immuno)therapy and of the number of cycles received as first and second line.
timeFrame: 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.
measure: Frequencies of the type of Central Nervous System (CNS) prophylaxis
timeFrame: 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.
measure: Cumulative incidence rate of Central Nervous System (CNS) relapse detected during treatment or follow-up.
timeFrame: 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.
measure: Characteristics of patients
timeFrame: 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.
Other outcomes:
Locations:
city: Pagani
country: Italy
facility: Presidio ospedaliero "A. TORTORA" - U.O. Onco-ematologia
state: Salerno
city: Sassari
country: Italy
facility: AOU di Sassari - Ematologia
state: SS
city: Trieste
country: Italy
facility: Azienda Sanitaria Universitaria Giuliano Isontina (ASUGI) - SC Ematologia
state: TS
city: Mestre
country: Italy
facility: Ospedale Dell'angelo - U.O. Ematologia
state: Venezia
city: Bergamo
country: Italy
facility: Azienda Ospedaliera Papa Giovanni XXIII - Ematologia
city: Brescia
country: Italy
facility: ASST Spedali Civili di Brescia - Ematologia
city: Ferrara
country: Italy
facility: Azienda Ospedaliero-Universitaria di Ferrara - Arcispedale Sant'Anna - Ematologia e fisiopatologia della coagulazione
city: Milano
country: Italy
facility: Istituto Scientifico San Raffaele - Unitа Linfomi - Dipartimento Oncoematologia
city: Milano
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori di Milano - Ematologia
city: Milano
country: Italy
facility: ASST Grande Ospedale Metropolitano Niguarda - SC Ematologia
city: Perugia
country: Italy
facility: Ospedale S. Maria della Misericordia - Ematologia
city: Pisa
country: Italy
facility: AOU Pisana - U.O. Ematologia
city: Roma
country: Italy
facility: Roma - Universitа Cattolica S. Cuore - Ematologia
city: Roma
country: Italy
facility: AO Sant'Andrea - Ematologia
city: Terni
country: Italy
facility: A.O. S. Maria di Terni - S.C. Oncoematologia
city: Torino
country: Italy
facility: A.O.U. Città della Salute e della Scienza di Torino - Ematologia Universitaria
city: Verona
country: Italy
facility: AOU Integrata di Verona - U.O. Ematologia
Study officials:
affiliation: Trieste - Azienda Sanitaria Universitaria Giuliano Isontina (ASUGI) - SC Ematologia
name: Elisa Lucchini, MD
role: PRINCIPAL_INVESTIGATOR
References: