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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorStichting Hemato-Oncologie voor Volwassenen Nederland

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

324 Participants
are divided into 2 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