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

Fondazione Italiana Linfomi - ETS127 enrolled

Overview

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.

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%.

Study Type

OBSERVATIONAL

Enrollment

127

Conditions

Lymphoma Large B-Cell Diffuse Large B-Cell

Interventions

R-CHOP with doxorubicinDRUG

Chemoimmunotherapy 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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (18)

AO Riuniti Papardo Piemonte

Messina, ME, Italy

ASST Grande Ospedale Metropolitano Niguarda

Milan, MI, Italy

Outcomes

Primary Outcomes

Cardiotoxicity

defined as the rate of cardiovascular events classified according to the Lenihan criteria 2013

Time frame: 1 year from enrollment

Secondary Outcomes

Overall response rate (ORR)

defined according to international criteria (Cheson 2007)

Time frame: 6 months from enrollment

Rate of response to treatment

defined according to international criteria (Cheson 2007)

Time frame: 6 months from enrollment

Overall survival (OS)

It will be calculated for all patients enrolled in the study from the date of start of therapy to the date of death or last follow-up.

Time frame: 3 years from enrollment

Progression-free survival (PFS)

It will be calculated for all patients from the start of therapy given to the date of progression or death or last follow-up.

Time frame: 3 years from enrollment

failure-free survival (FFS)

It will be calculated for all patients from the therapy start date to the date of an event or last follow-up. The events considered for the FFS definition are the following: treatment discontinuation for toxicity, response \<RC, relapse / progression, death for any cause.

Time frame: 3 years from enrollment

Freedom From cardiovascular Event (FFCE)

calculated for all patients from the therapy start date to the time of occurrence of a cardiovascular event as defined by primary endopoint or follow-up date.

Data from ClinicalTrials.gov

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