RecruitingPhase 3NCT06220032

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

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


Sponsor

Stichting Hemato-Oncologie voor Volwassenen Nederland

Enrollment

324 participants

Start Date

Aug 15, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether adding dexrazoxane — a heart-protective drug — to standard R-CHOP chemotherapy can prevent heart damage in patients with diffuse large B-cell lymphoma (DLBCL), a common and aggressive form of blood cancer. Anthracyclines in R-CHOP are highly effective but can be toxic to the heart over time. **You may be eligible if...** - You are 18 or older with a newly diagnosed CD20-positive DLBCL or related high-grade B-cell lymphoma - You have stage II–IV disease (or stage I with a large, bulky tumor) - You are planned to receive 6 cycles of R-CHOP chemotherapy - You are in adequate overall health (WHO performance status ≤2) **You may NOT be eligible if...** - Your lymphoma involves the central nervous system (brain or spinal cord) - You have testicular DLBCL or primary mediastinal B-cell lymphoma - You have already received prior chemotherapy for this lymphoma - You have a pre-existing significant heart condition - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDexrazoxane

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.

DRUGRituximab

Day 1 Cycle 1-6: 375 mg/m2 (iv)

DRUGCyclophosphamide

Day 1 Cycle 1-6: 750 mg/m2 (iv)

DRUGDoxorubicin

Day 1 Cycle 1-6: 50 mg/m2 (iv)

DRUGVincristine

Day 1 Cycle 1-6: 1.4 mg/m2 (max 2 mg) (iv)

DRUGPrednisolone

Day 1-5 Cycle 1-6: 100 mg (oral)

DRUGLenalidomide

Day 1-14 Cycle 1-6: 15 mg day (oral) Only in case of a double hit lymphoma.

DRUGPegfilgrastim

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

View Full Details on ClinicalTrials.gov

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NCT06220032


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