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Chemo heart risk under the microscope in lymphoma patients

NCT ID NCT02916316

Knowledge-focused Sponsor: Fondazione Italiana Linfomi - ETS Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study followed 127 people with diffuse large B-cell lymphoma who were treated with a common chemotherapy regimen called R-CHOP. The main goal was to track how often heart problems occurred as a side effect of the treatment. Researchers also looked at how well the cancer responded and overall survival. The study did not test a new treatment but rather observed real-world outcomes to better understand heart risks.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

127 people

The number who actually took part.

Started

Feb 2014

Finished

Dec 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Diffuse Large B-Cell Lymphoma

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Cardiotoxicity diffuse large B-cell lymphoma large B-cell lymphoma lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diffuse large B-cell Large B-cell Lymphoma

Contacts and locations

Locations

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

    Ancona, 60126, Italy

  • A.O. Universitaria Policlinico Di Modena

    Modena, MO, 41124, Italy

  • AO Riuniti Papardo Piemonte

    Messina, ME, 98158, Italy

  • AOU Universitа degli Studi della Campania Luigi Vanvitelli

    Naples, Italy

  • ASST Grande Ospedale Metropolitano Niguarda

    Milan, MI, 20162, Italy

  • Azienda Unitа Sanitaria Locale-IRCCS - Arcispedale Santa Maria Nuova

    Reggio Emilia, 50139, Italy

  • Ematologia e Trapianto Istituto Regina Elena IFO

    Roma, Italy

  • Istituto Clinico Humanitas

    Rozzano, MI, Italy

  • Istituto Oncologico Veneto

    Padova, 35128, Italy

  • Nuovo Ospedale Di Sassuolo S.P.A.

    Sassuolo, Modena, 41049, Italy

  • Osp.Sant'Eugenio Divisione di Ematologia

    Roma, Italy

  • Ospedale Ca Foncello

    Treviso, Italy

  • Ospedale Riuniti di Foggia

    Foggia, Italy

  • Ospedale S. Giacomo di Castelfranco Veneto

    Castelfranco Veneto, Italy

  • Ospedali Riuniti Villa Sofia - Cervello

    Palermo, PA, 90146, Italy

  • U.O. Complessa di Ematologia Ospedale di Parma

    Parma, 43100, Italy

  • UO Ematologia PO Vito Fazzi

    Lecce, Italy

  • UO Ematologia e CTMO di Piacenza

    Piacenza, PC, 29121, Italy

More trials for these conditions

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