Primary Cardiac Lymphoma: Italian Multicenter Experience
ConditionPrimary Cardiac Lymphoma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFondazione Italiana Linfomi - ETS
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial population
Patient affected by primary cardiac lymphoma from 1st January 2000 to 31st December 2020.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Not listed
Trial groups
43 Participants
are grouped into 1 trial groupGroup A: Patients enrolled
Trial outcomes
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).
Time frame
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
1
Complete remission (CR)
The Complete Remission is defined as the lack of detectable evidence of tumor in the cohort of patients (patients with cardiac lymphoma diagnosed from 01/01/2000 to 31/12/2020).
Time frame
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 2023.2
Overall Response Rate (ORR)
The Overall Response Rate is defined as the proportion of patients who have a partial or complete response to therapy (patients with cardiac lymphoma diagnosed from 01/01/2000 to 31/12/2020).
Time frame
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 2023.3
Progression-Fee Survival (PFS)
The Progression-Free Survival is the length of time during and after the treatment that patients live with the disease, but it does not get worse (patients with cardiac lymphoma diagnosed from 01/01/2000 to 31/12/2020).
Time frame
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 2023.4
Frequencies of the type of chemo(immuno)therapy and of the number of cycles received as first and second line.
The numbers of treatment types and numbers of cycles of therapy received by the cohort of patients (patients with cardiac lymphoma diagnosed from 01/01/2000 to 31/12/2020).
Time frame
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.Sponsors and contacts
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Source ClinicalTrials.gov