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Life sciences · Phase 3 Trial
ClinicalTrials.gov · September 23, 2026
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Phase 3 Trial.
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Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
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Registry record from ClinicalTrials.gov (NCT06220032). This is a study registration, not published results. Lead sponsor: Stichting Hemato-Oncologie voor Volwassenen Nederland. Recruitment status: RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 324 participants (ESTIMATED). Conditions: DLBCL - Diffuse Large B Cell Lymphoma. Interventions: DRUG: Dexrazoxane; DRUG: Rituximab; DRUG: Cyclophosphamide; DRUG: Doxorubicin; DRUG: Vincristine; DRUG: Prednisolone; DRUG: Lenalidomide; DRUG: Pegfilgrastim. Primary outcome measures: The incidence of AICD. , 12 months after LPI. Brief summary: Patients treated for DLBCL are at high risk of developing AICD. This adverse event is characterized by irreversible damage to the heart muscle with a loss of cardiomyocytes and subsequent decline in cardiac pumping capacity. Thereby patients treated for this malignancy are at double the risk of developing symptomatic heart failure / cardiomyopathy when compared to the general population. This corresponds to a cumulative incidence of 5-10% within 5-years after receiving R-CHOP. In the elderly, an incidence of 26% has been reported after 8-years of follow-up. Among patients who die in complete remission, heart failure has been described to be one of the most important causes of death. ANTICIPATE aims to evaluate if dexrazoxane can prevent AICD in DLBCL patients and identify those at highest risk of AICD. Of all patients treated with anthracyclines in a first-line setting, DLBCL patients were chosen for this trial for two primary reasons. Firstly, these patients have a favourable oncological prognosis with a 5-year relative survival in the Netherlands of 64-78% in those aged 18-74 years increasing the importance of preventing long-term toxicity. Secondly, the cumulative anthracycline dose used for the treatment of DLBCL is higher than the dose used in breast cancer. The cumulative anthracycline dose is the most important risk factor for AICD known.