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Actively Recruiting

Phase 3
Age: 18Years +
All Genders
ID06220032

Preventing Heart Damage with Dexrazoxane in Adults Treated for Diffuse Large B-Cell Lymphoma Using R-CHOP Chemotherapy

Led by Stichting Hemato-Oncologie voor Volwassenen Nederland · Updated on 2026-01-05

324

Participants Needed

25

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating whether dexrazoxane can prevent anthracycline-induced cardiac dysfunction AICD in patients with Diffuse Large B Cell Lymphoma DLBCL. Patients treated for DLBCL have a high risk of developing AICD, which causes irreversible heart muscle damage and can lead to heart failure. This trial focuses on DLBCL patients because they receive higher doses of anthracyclines and have a favorable cancer prognosis, making prevention of long-term heart damage especially important. This national, phase III randomized controlled trial includes adults with DLBCL planned to receive six cycles of R-CHOP chemotherapy. Participants are randomly assigned to receive either dexrazoxane intravenously before each doxorubicin infusion or standard R-CHOP treatment without cardioprotective therapy. The trial does not use a placebo due to the nature of dexrazoxane. Cardiac function is monitored with echocardiography before treatment and at 4 and 12 months after starting therapy. Participants will undergo heart function assessments including left ventricular ejection fraction LVEF measurements, along with evaluations of metabolic remission, survival, cardiac biomarkers, and quality of life over 12 months. The study aims to identify patients at highest risk of AICD and confirm that dexrazoxane does not reduce the cancer treatments effectiveness. The total follow-up period is 12 months after the last patient inclusion to assess heart health and treatment outcomes.

CONDITIONS

Brief Title

Prevention of Anthracycline-Induced Cardiac Dysfunction With Dexrazoxane in Patients With Diffuse Large-B Cell Lymphoma

Research Team

A

A. van Rhenen, MD

M

M.P.M. Linschoten, MD

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