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Preventing heart damage in lymphoma patients receiving chemotherapy

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

Phase 3 Interventional Stichting Hemato-Oncologie voor Volwassenen Nederland · NCT06220032

This study is testing if a drug called dexrazoxane can help prevent heart damage in adults with lymphoma who are receiving chemotherapy.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment324 (estimated)
Ages18 Years and up
SexAll
SponsorStichting Hemato-Oncologie voor Volwassenen Nederland Academic / other
Drugs / interventionsrituximab, prednisone, chemotherapy, cyclophosphamide, doxorubicin
Locations25 sites ('s-Hertogenbosch and 24 other locations)
Trial IDNCT06220032 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of dexrazoxane in preventing anthracycline-induced cardiac dysfunction (AICD) in patients with diffuse large B-cell lymphoma (DLBCL) undergoing first-line treatment with R-CHOP chemotherapy. A total of 324 adult patients with normal cardiac function will be randomized to receive either dexrazoxane or standard care prior to each doxorubicin infusion. Cardiac function will be monitored through echocardiography at baseline and at 4 and 12 months post-treatment. The primary goal is to assess the incidence of AICD, defined by a significant decline in left ventricular ejection fraction.

Who should consider this trial

Good fit: Ideal candidates are untreated adults with a confirmed diagnosis of CD20+ DLBCL who are scheduled to receive R-CHOP chemotherapy.

Not a fit: Patients with pre-existing cardiac dysfunction or those not receiving anthracycline-based chemotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the risk of heart failure in lymphoma patients treated with anthracyclines.

How similar studies have performed: Previous studies have indicated potential benefits of cardioprotective agents like dexrazoxane in similar patient populations, suggesting a promising avenue for reducing cardiotoxicity.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Untreated patients with a confirmed histologic diagnosis of CD20+ DLBCL according to WHO classification 2022:

   * 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
   * T-cell/histiocyte-rich B cell lymphoma (THRBCL)

   Note: Transformed, previously untreated lymphoma is allowed.

   Note: 5-day treatment of dexamethasone 15 mg/day or prednisone 100 mg/day or local radiotherapy in order to control life-threatening/invalidating tumor related symptoms is allowed.

   Note: It is allowed to start with a first cycle of R-CHOP21 pending the FISH results.
2. Planned treatment with 6 R-CHOP21. The following regimens are also allowed:

   * Treatment with reversed R-CHOP21
   * Treatment with R2-CHOP21 (6 R-CHOP21 + lenalidomide 15 mg day 1-14) in case of double hit lymphoma
   * Two additional administrations of rituximab after 6 cycles of R-CHOP21
   * High dosis MTX and/or MTX-it for CNS prophylaxis
3. 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);
4. Age ≥ 18 years;
5. WHO performance status ≤ 2, WHO 3 performance status is allowed when considered directly related to the DLBCL;
6. Negative pregnancy test at study entry for women of childbearing potential;
7. Female patient is either post-menopausal for at least 1 year before the screening visit or surgically sterile or if of childbearing potential, agrees to practice two effective methods of contraception, at the same time, from the time of signing the informed consent through at least 12 months after the last dose of protocol treatment, or agrees to completely abstain from heterosexual intercourse;
8. Male patient, even if surgically sterilized, (i.e., status post vasectomy) agrees to practice effective barrier contraception during the entire study period and through 12 months after the last dose of protocol treatment, or agrees to completely abstain from heterosexual intercourse;
9. Patient is able to adhere to the study visit schedule and other protocol requirements;
10. Written informed consent.

Exclusion Criteria:

1. Any of the following B-cell lymphomas according to WHO classification 2022:

   o Central Nervous System involvement by DLBCL;

   Note: high CNS-IPI is allowed
   * Testicular DLBCL;
   * Primary mediastinal B-cell lymphoma;
   * Epstein-Barr virus (EBV) post-transplant lymphoproliferative disorder;
2. 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.
3. Patients requiring treatment with mini-R-CHOP
4. 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
5. Non-diagnostic/poor transthoracic echocardiography imaging quality at baseline;
6. Severe pulmonary dysfunction defined as breathlessness at rest (COPD GOLD III or IV), unless clearly related to DLBCL;
7. Severe neurological or psychiatric disease;
8. Inadequate hematological function (absolute Neutrophil Count (ANC) \<1.0x109/L or platelets \<75x109/L), unless clearly related to DLBCL;
9. Significant hepatic dysfunction (serum bilirubin or transaminases ≥ 3 times the upper limit of normal) unless related to lymphoma infiltration of the liver;
10. Active hepatitis B or C infection (serology testing is required at screening). Patients positive for hepatitis B surface antigen (HBsAg) regardless of antibody status or HBsAg negative but anti-HBc positive are only eligible if HBV-PCR is negative and patients are protected with lamuvidine or entecavir. Patients with positive hepatitis C serology are only eligible if HCV-(RNA) is confirmed negative;
11. Significant renal dysfunction (creatinine clearance \< 30 ml/min after rehydration) or requiring dialysis;
12. Active uncontrolled fungal, bacterial and/or viral infection;
13. Patient known to be HIV-positive;
14. Breast-feeding female patients;
15. Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule;
16. Participation in another clinical trial with anti-cancer therapy or a cardiovascular drug.

Where this trial is running

's-Hertogenbosch and 24 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions DLBCL - Diffuse Large B Cell Lymphomadexrazoxaneprimary preventioncardiotoxicityheart failurediffuse large B-cell lymphomaR-CHOPFL
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.