TY - JOUR
T1 - Rationale and design of the HOVON 170 DLBCL-ANTICIPATE trial
T2 - preventing anthracycline-induced cardiac dysfunction with dexrazoxane
AU - Linschoten, Marijke
AU - Geels, Jesse
AU - van Werkhoven, Erik
AU - Visser-Wisselaar, Heleen
AU - Chamuleau, Martine E D
AU - Teske, Arco J
AU - Robbers, Lourens
AU - Oerlemans, Simone
AU - Crommelin, Heleen
AU - Breems-de Ridder, Marleen
AU - Schut, Astrid
AU - Asselbergs, Folkert W
AU - van Rhenen, Anna
N1 - Publisher Copyright:
© The Author(s) 2025.
PY - 2025/1/28
Y1 - 2025/1/28
N2 - BACKGROUND: Dexrazoxane has been studied for its ability to prevent anthracycline-induced cardiac dysfunction (AICD) in several trials but its use in clinical practice remains limited. This is related to the low to moderate quality of the generated evidence, safety concerns and restricted prescribing indications. Additional randomized trials are needed before this drug can be routinely integrated into cardio-oncology clinical practice.OBJECTIVES: To describe the rationale and design of the HOVON 170 DLBCL - ANTICIPATE trial. This trial aims to establish the efficacy and safety of dexrazoxane for the primary prevention of AICD in patients diagnosed with Diffuse Large B-Cell Lymphoma (DLBCL) treated with six cycles R-CHOP
21 chemo-immunotherapy.
METHODS: This is a multicenter, parallel-group, open-label, phase III trial, randomizing 324 patients between either no cardioprotective treatment or dexrazoxane from the first R-CHOP cycle. The primary and co-primary endpoints are the incidence of AICD within 12 months of registration and the percentage of patients with complete metabolic remission at the end-of-treatment PET-CT respectively. The trial is registered at the EU Clinical Trials Register (EU-CT number 2023-505377-32) and ClinicalTrials.gov (NCT06220032).RESULTS: The medical research ethics committee approved the trial in May 2024. Recruitment has started in September 2024 and is expected to last for three years.CONCLUSIONS: This trial is poised to contribute crucial evidence concerning the efficacy and safety on the use of dexrazoxane in the primary prevention of AICD. The trial is anticipated to address critical knowledge gaps and offer important insights into the value of dexrazoxane in cardio-oncology practice.
AB - BACKGROUND: Dexrazoxane has been studied for its ability to prevent anthracycline-induced cardiac dysfunction (AICD) in several trials but its use in clinical practice remains limited. This is related to the low to moderate quality of the generated evidence, safety concerns and restricted prescribing indications. Additional randomized trials are needed before this drug can be routinely integrated into cardio-oncology clinical practice.OBJECTIVES: To describe the rationale and design of the HOVON 170 DLBCL - ANTICIPATE trial. This trial aims to establish the efficacy and safety of dexrazoxane for the primary prevention of AICD in patients diagnosed with Diffuse Large B-Cell Lymphoma (DLBCL) treated with six cycles R-CHOP
21 chemo-immunotherapy.
METHODS: This is a multicenter, parallel-group, open-label, phase III trial, randomizing 324 patients between either no cardioprotective treatment or dexrazoxane from the first R-CHOP cycle. The primary and co-primary endpoints are the incidence of AICD within 12 months of registration and the percentage of patients with complete metabolic remission at the end-of-treatment PET-CT respectively. The trial is registered at the EU Clinical Trials Register (EU-CT number 2023-505377-32) and ClinicalTrials.gov (NCT06220032).RESULTS: The medical research ethics committee approved the trial in May 2024. Recruitment has started in September 2024 and is expected to last for three years.CONCLUSIONS: This trial is poised to contribute crucial evidence concerning the efficacy and safety on the use of dexrazoxane in the primary prevention of AICD. The trial is anticipated to address critical knowledge gaps and offer important insights into the value of dexrazoxane in cardio-oncology practice.
KW - Anthracyclines
KW - Cardiotoxicity
KW - Dexrazoxane
KW - Diffuse large B-Cell lymphoma
KW - R-CHOP chemotherapy
KW - Randomized Controlled Trial
UR - http://www.scopus.com/inward/record.url?scp=85218229256&partnerID=8YFLogxK
U2 - 10.1186/s40959-025-00303-y
DO - 10.1186/s40959-025-00303-y
M3 - Article
C2 - 39875951
SN - 2057-3804
VL - 11
JO - Cardio-oncology (London, England)
JF - Cardio-oncology (London, England)
IS - 1
M1 - 8
ER -