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

• Status: Active, not recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fondazione Italiana Linfomi ONLUS
• Treatments: Doxorubicin; Liposomal doxorubicin

Criteria

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