About this trial
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.
Eligibility criteria
Qualifiers
DLBCL, not otherwise specified (NOS)
High-grade B-cell lymphoma NOS
High-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 translocation when DA-EPOCH-R is not an option. R2- CHOP is allowed.
Follicular lymphoma
Disqualifiers
Testicular DLBCL;
Primary mediastinal B-cell lymphoma;
Epstein-Barr virus (EBV) post-transplant lymphoproliferative disorder;
Any prior malignancy or present malignancy other than DLBCL that required or requires systemic therapy. Prior surgery or local radiotherapy is allowed in case the heart has not been exposed.
Trial design
Treatments tested in this trial
- Dexrazoxane
- Rituximab
- Cyclophosphamide
- Doxorubicin
- Vincristine
- Prednisolone
- Lenalidomide
- Pegfilgrastim
Treatment groups
Sponsors and collaborators
Stichting Hemato-Oncologie voor Volwassenen Nederland
Lead sponsor
UMC Utrecht
Collaborator
Amsterdam UMC, location VUmc
Collaborator
The Dutch Network for Cardiovascular Research (WCN)
Collaborator