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

December 14, 2023 updated by: Fondazione Italiana Linfomi - ETS

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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%.

Study Type

Observational

Enrollment (Actual)

127

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Ancona, Italy, 60126
        • A.O. Universitaria Ospedali Riuniti - Ospedale Umberto I Di Ancona
      • Castelfranco Veneto, Italy
        • Ospedale S. Giacomo di Castelfranco Veneto
      • Foggia, Italy
        • Ospedale Riuniti di Foggia
      • Lecce, Italy
        • UO Ematologia PO Vito Fazzi
      • Napoli, Italy
        • AOU Universitа degli Studi della Campania Luigi Vanvitelli
      • Padova, Italy, 35128
        • Istituto Oncologico Veneto
      • Parma, Italy, 43100
        • U.O. Complessa di Ematologia Ospedale di Parma
      • Reggio Emilia, Italy, 50139
        • Azienda Unitа Sanitaria Locale-IRCCS - Arcispedale Santa Maria Nuova
      • Roma, Italy
        • Ematologia e Trapianto Istituto Regina Elena IFO
      • Roma, Italy
        • Osp.Sant'Eugenio Divisione di Ematologia
      • Treviso, Italy
        • Ospedale Cà Foncello
    • ME
      • Messina, ME, Italy, 98158
        • AO Riuniti Papardo Piemonte
    • MI
      • Milano, MI, Italy, 20162
        • ASST Grande Ospedale Metropolitano Niguarda
      • Rozzano, MI, Italy
        • Istituto Clinico Humanitas
    • MO
      • Modena, MO, Italy, 41124
        • A.O. Universitaria Policlinico Di Modena
    • Modena
      • Sassuolo, Modena, Italy, 41049
        • Nuovo Ospedale Di Sassuolo S.P.A.
    • PA
      • Palermo, PA, Italy, 90146
        • Ospedali Riuniti Villa Sofia - Cervello
    • PC
      • Piacenza, PC, Italy, 29121
        • UO Ematologia e CTMO di Piacenza

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Diffuse Large B-Cell Lymphoma

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Drug: 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.
Other Names:
  • R-CHOP with doxorubicin analogue
  • R-COMP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiotoxicity
Time Frame: 1 year from enrollment
defined as the rate of cardiovascular events classified according to the Lenihan criteria 2013
1 year from enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall response rate (ORR)
Time Frame: 6 months from enrollment
defined according to international criteria (Cheson 2007)
6 months from enrollment
Rate of response to treatment
Time Frame: 6 months from enrollment
defined according to international criteria (Cheson 2007)
6 months from enrollment
Overall survival (OS)
Time Frame: 3 years from enrollment
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.
3 years from enrollment
Progression-free survival (PFS)
Time Frame: 3 years from enrollment
It will be calculated for all patients from the start of therapy given to the date of progression or death or last follow-up.
3 years from enrollment
failure-free survival (FFS)
Time Frame: 3 years from enrollment

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.
3 years from enrollment
Freedom From cardiovascular Event (FFCE)
Time Frame: 3 years from enrollment
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.
3 years from enrollment
Number of events recorded during the treatment and codified according to NCI-CTC v4.03
Time Frame: 3 years from enrollment
it will be defined by the number of events recorded during the treatment and codified according to NCI-CTC v4.03
3 years from enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Italiana Linfomi - ETS

Investigators

  • Principal Investigator: Guido Gini, MD, AOU Ospedali Riuniti, Ematologia ANCONA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 12, 2014

Primary Completion (Actual)

December 30, 2020

Study Completion (Estimated)

February 1, 2031

Study Registration Dates

First Submitted

September 21, 2016

First Submitted That Met QC Criteria

September 23, 2016

First Posted (Estimated)

September 27, 2016

Study Record Updates

Last Update Posted (Estimated)

December 15, 2023

Last Update Submitted That Met QC Criteria

December 14, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FIL_Cardio-DLBCL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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