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MinorEligibility criteria expanded, about 44 wordsSecondary endpoints: details revised at 7 of 7 entries · Publications: details revised at 1 of 1 entryShow 2 more changesShow less
Secondary endpoints: details revised at 7 of 7 entries
Publications: details revised at 1 of 1 entry
MinorSite details revised at 23 of 25 sitesv5
MinorSite details revised at 1 of 25 sitesv4
NotableTrial status: Not Yet Recruiting to RecruitingStudy sites: 24 to 25 · Start date changed from estimate of May 21, 2024 to Aug 15, 2024v3Show 2 more changesShow less
Study sites: 24 to 25
Start date changed from estimate of May 21, 2024 to Aug 15, 2024
MinorStudy sites: 25 to 24Interventions: Cyclophosphamide (Drug), Dexrazoxane (Drug), Doxorubicin (Drug), Lenalidomide (Drug), Prednisolone (Drug), Rituximab (Drug), Vincristine… to Cyclophosphamide (Drug), Dexrazoxane (Drug), Doxorubicin (Drug), Lenalidomide (Drug), Pegfilgrastim (Drug), Prednisolone (Drug), Rituximab…v2Show 1 more changeShow less
Stopped: an ongoing trial was terminated, suspended or withdrawn.
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.