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

NCT ID: NCT02916316

Last Updated: 2025-11-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 127 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-02-12
• Study Completion Date: 2024-12-31

Brief 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.

Detailed 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%.

Conditions

Lymphoma; Large B-Cell; Diffuse Large B-Cell

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Chemo immunotherapy

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.

R-CHOP with doxorubicin

Intervention Type: DRUG

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.

Interventions

R-CHOP with doxorubicin

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.

Intervention Type: DRUG

Other Intervention Names

R-CHOP with doxorubicin analogue; R-COMP

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Italiana Linfomi - ETS

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Guido Gini, MD

Role: PRINCIPAL_INVESTIGATOR

AOU Ospedali Riuniti, Ematologia ANCONA

Locations

AO Riuniti Papardo Piemonte

Messina, ME, Italy

ASST Grande Ospedale Metropolitano Niguarda

Milan, MI, Italy

Istituto Clinico Humanitas

Rozzano, MI, Italy

Nuovo Ospedale Di Sassuolo S.P.A.

Sassuolo, Modena, Italy

A.O. Universitaria Policlinico Di Modena

Modena, MO, Italy

Ospedali Riuniti Villa Sofia - Cervello

Palermo, PA, Italy

UO Ematologia e CTMO di Piacenza

Piacenza, PC, Italy

A.O. Universitaria Ospedali Riuniti - Ospedale Umberto I Di Ancona

Ancona, , Italy

Ospedale S. Giacomo di Castelfranco Veneto

Castelfranco Veneto, , Italy

Ospedale Riuniti di Foggia

Foggia, , Italy

UO Ematologia PO Vito Fazzi

Lecce, , Italy

AOU Universitа degli Studi della Campania Luigi Vanvitelli

Napoli, , Italy

Istituto Oncologico Veneto

Padua, , Italy

U.O. Complessa di Ematologia Ospedale di Parma

Parma, , Italy

Azienda Unitа Sanitaria Locale-IRCCS - Arcispedale Santa Maria Nuova

Reggio Emilia, , Italy

Ematologia e Trapianto Istituto Regina Elena IFO

Roma, , Italy

Osp.Sant'Eugenio Divisione di Ematologia

Roma, , Italy

Ospedale Ca Foncello

Treviso, , Italy

Countries

Italy

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Other Identifiers

FIL_Cardio-DLBCL

Identifier Type: -

Identifier Source: org_study_id