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Prevention of Anthracycline-Induced Cardiac Dysfunction With Dexrazoxane in Patients With Diffuse Large-B Cell Lymphoma
Sponsor: Stichting Hemato-Oncologie voor Volwassenen Nederland
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.
Official title: ANTICIPATE: Prevention of ANThracycline-Induced Cardiac Dysfunction by Dexrazoxane In PATients With diffusE Large B-cell Lymphoma: a Phase III National Multicenter Prospective Randomized Open-label Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
324
Start Date
2024-08-15
Completion Date
2028-12-15
Last Updated
2026-01-05
Healthy Volunteers
No
Conditions
Interventions
Dexrazoxane
Day 1 Cycle 1-6: Dexrazoxane 500 mg/m2 (iv) will be given 30 minutes before doxorubicin infusion and should be infused during 15 minutes.
Rituximab
Day 1 Cycle 1-6: 375 mg/m2 (iv)
Cyclophosphamide
Day 1 Cycle 1-6: 750 mg/m2 (iv)
Doxorubicin
Day 1 Cycle 1-6: 50 mg/m2 (iv)
Vincristine
Day 1 Cycle 1-6: 1.4 mg/m2 (max 2 mg) (iv)
Prednisolone
Day 1-5 Cycle 1-6: 100 mg (oral)
Lenalidomide
Day 1-14 Cycle 1-6: 15 mg day (oral) Only in case of a double hit lymphoma.
Pegfilgrastim
6 mg (1 dose per cycle) in case of neutropenia. Pegfilgastim is mandatory in patients that receive R2-CHOP21.
Locations (25)
NL-Den Bosch-JBZ
's-Hertogenbosch, Netherlands
NL-Almelo-ZGTALMELO
Almelo, Netherlands
NL-Amstelveen-AMSTELLAND
Amstelveen, Netherlands
NL-Apeldoorn-GELREAPELDOORN
Apeldoorn, Netherlands
NL-Arnhem-RIJNSTATE
Arnhem, Netherlands
NL-Breda-AMPHIA
Breda, Netherlands
NL-Delft-RDGG
Delft, Netherlands
NL-Dordrecht-ASZ
Dordrecht, Netherlands
NL-Eindhoven-CATHARINA
Eindhoven, Netherlands
NL-Eindhoven-MAXIMAMC
Eindhoven, Netherlands
NL-Goes-ADRZ
Goes, Netherlands
NL-Groningen-MARTINI
Groningen, Netherlands
NL-Harderwijk-STJANSDALHARDERWIJK
Harderwijk, Netherlands
NL-Hilversum-TERGOOI
Hilversum, Netherlands
NL-Hoofddorp-SPAARNEGASTHUIS
Hoofddorp, Netherlands
NL-Nieuwegein-ANTONIUS
Nieuwegein, Netherlands
NL-Nijmegen-CWZ
Nijmegen, Netherlands
NL-Rotterdam-IKAZIA
Rotterdam, Netherlands
NL-Schiedam-FRANCISCUSVLIETLAND
Schiedam, Netherlands
NL-Sittard-ZUYDERLAND MC
Sittard, Netherlands
NL-Sneek-ANTONIUSSNEEK
Sneek, Netherlands
NL-Den Haag-HAGA
The Hague, Netherlands
NL-Utrecht-UMCUTRECHT
Utrecht, Netherlands
NL-Venlo-VIECURI
Venlo, Netherlands
NL-Zwolle-ISALA
Zwolle, Netherlands