OncoMatch/Clinical Trials/NCT06220032
Prevention of Anthracycline-Induced Cardiac Dysfunction With Dexrazoxane in Patients With Diffuse Large-B Cell Lymphoma
Is NCT06220032 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments for dlbcl - diffuse large b cell lymphoma.
Treatment: Dexrazoxane · Rituximab · Cyclophosphamide · Doxorubicin · Vincristine · Prednisolone · Lenalidomide · Pegfilgrastim — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Diffuse Large B-Cell Lymphoma
Non-Hodgkin Lymphoma
Biomarker criteria
Required: CD20 overexpression (CD20+)
confirmed histologic diagnosis of CD20+ DLBCL
Allowed: MYC translocation
High-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 translocation
Allowed: BCL2 translocation
High-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 translocation
Allowed: BCL6 translocation
High-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 translocation
Disease stage
Required: Stage ANN ARBOR II, ANN ARBOR III, ANN ARBOR IV, ANN ARBOR I IF THE TREATMENT PLAN IS 6 R-CHOP21 IN CASE OF BULKY DISEASE (Ann Arbor)
Ann Abor stages II-IV and stage I if the treatment plan is 6 R-CHOP21 in case of bulky disease (defined as a ≥10 cm mass)
Performance status
WHO 0–2
Prior therapy
Cannot have received: systemic therapy for malignancy
Exception: prior surgery or local radiotherapy is allowed in case the heart has not been exposed
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.
Cannot have received: mini-R-CHOP
Patients requiring treatment with mini-R-CHOP
Lab requirements
Blood counts
absolute Neutrophil Count (ANC) ≥1.0x10^9/L and platelets ≥75x10^9/L unless clearly related to DLBCL
Kidney function
creatinine clearance ≥ 30 ml/min after rehydration, not requiring dialysis
Liver function
serum bilirubin or transaminases < 3 times the upper limit of normal unless related to lymphoma infiltration of the liver
Cardiac function
LVEF ≥50% measured with echocardiography (2D or 3D); no symptomatic heart failure (NYHA <II); no hospitalization for heart failure in the last year; no refractory anginal symptoms; cardiac arrhythmias controlled with optimal medical treatment (atrial fibrillation ventricular response <110/min); no significant valvular dysfunction on echocardiography; no non-ischemic cardiomyopathy
Pre-existing cardiac disease including: LVEF <50% measured with echocardiography (2D or 3D); Symptomatic heart failure (NYHA ≥II) or hospitalization for heart failure in the last year; Refractory anginal symptoms; Cardiac arrhythmias not controlled with optimal medical treatment, in case of atrial fibrillation the ventricular response needs to be <110/min; Significant valvular dysfunction on echocardiography; Non-ischemic cardiomyopathy. Inadequate hematological function (absolute Neutrophil Count (ANC) <1.0x10^9/L or platelets <75x10^9/L), unless clearly related to DLBCL; Significant hepatic dysfunction (serum bilirubin or transaminases ≥ 3 times the upper limit of normal) unless related to lymphoma infiltration of the liver; Significant renal dysfunction (creatinine clearance < 30 ml/min after rehydration) or requiring dialysis.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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