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

Fondazione Italiana Linfomi - ETS

Status: Completed

Conditions: Large B-Cell; Diffuse Large B-Cell; Lymphoma

Treatments: Drug: R-CHOP with doxorubicin

Study type: Observational

Funder types: Other

Identifiers

NCT02916316

FIL_Cardio-DLBCL

Details and patient eligibility

About

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.

Full description

The study was designed as a prospective observational multicenter study to evaluate the role of possible early markers of cardiotoxicity estimating an overall maximum risk equal to 20% of patients. The sample size, required to obtain an estimate of conventional anthracycline cardiotoxicity in the population, has been calculated with a confidence interval of 95% and a maximum acceptable error of ± 0.075. According to the conditions described above, the sample size of patients treated with conventional anthracycline results to be 124 patients.

Considering a 10-15% of not evaluable patients, the sample size is fixed at 150 patients treated with R-CHOP. The duration of the enrollment phase is defined in 2 years.

With this sample size should be possible to assess the risk of cardiotoxicity related to predictors with a worst group frequency at least of 10%.

Enrollment: 127 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

127 participants in 1 patient group

Chemo immunotherapy

Description:

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.

Treatment:

Drug: R-CHOP with doxorubicin