Prospective Observational Study Investigating the Cardiotoxicity of Anthracyclines in Patients With Diffuse Large B-Cell

FIL_Cardio-DLBCL

All patients enrolled in the study will have to be treated with a chemo immunotherapy scheme R-CHOP with doxorubicin, with doxorubicin analogue or non pegylated liposomal anthracycline (R-COMP; Sec. 648 DM) administered every 21 days for 6 cycles. In unfavourable patients (stage II-IV) are allowed 2 additional cycles of rituximab at the end of the 6 cycles of R-CHOP.

2014-02-12

2020-12-30

2031-02-01

Active (not recruiting)

127

Inclusion Criteria: * Histologically confirmed Diffuse Large B-Cell Lymphoma diagnosis * Patient eligible to receive 6 cycles of R-CHOP or R-CHOP like chemotherapy at full doses * Age ≥ 18 * Stage I-IV * Written informed consent * ECOG Performance Status 0-3 * Ventricular Ejection Fraction (VEF) ≥40% * No previous treatment for lymphoma (except for RT-IF) * Negative β-HCG pregnancy test result at diagnosis for female of childbearing potential * Use of acceptable method of contraception during the study and for 3 months after receiving the last dose of study drug for patients with childbearing potential * Availability of the patient to be followed for all the phases of the chemotherapy treatment and for the subsequent follow-up Exclusion Criteria: * Inability to schedule a treatment at full doses of chemoimmunotherapy R-CHOP or R-CHOP-like for different reasons * Central nervous system involvement due to lymphoma * HIV * Active cardiac pathology including heart failure, left ventricular dysfunction documented by a LVEF \<40%, arrhythmias (rapid atrial fibrillation, frequent ventricular arrhythmias), valvular aortic or mitral disfunction \> moderate, ischemic heart disease (myocardial infarction or acute coronary syndrome for over 6 months, angina at rest or with mild efforts) * Previous treatment for lymphoma * Other malignancy in the 3 years prior to the diagnosis of lymphoma with exception of non-melanoma skin cancer or in situ carcinoma * Any other co-existing medical condition that would preclude participation in the study (uncontrolled bacterial or viral or fungal infection) * Pregnant, or lactating and breastfeeding female

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 127, 'type': 'ACTUAL'}}

2023-12-15