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Heart shield for lymphoma patients: new trial aims to stop Chemo-Induced heart failure

NCT ID NCT06220032

Prevention Sponsor: Stichting Hemato-Oncologie voor Volwassenen Nederland Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether the drug dexrazoxane can prevent heart damage caused by chemotherapy in people with diffuse large B-cell lymphoma (DLBCL). About 324 patients will receive either standard treatment plus dexrazoxane or standard treatment alone. The goal is to see if dexrazoxane reduces the risk of heart failure, a serious side effect that can occur years after treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 324 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2024

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Cardiotoxicity diffuse large B-cell lymphoma follicular lymphoma heart failure high grade B-cell lymphoma high grade B-cell lymphoma with MYC and/ or BCL2 and/or BCL6 rearrangement interdigitating dendritic cell sarcoma T-cell/histiocyte rich large B cell lymphoma cardiomyopathy due to anthracyclines prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

DLBCL - diffuse large B cell lymphoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    25 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • NL-Almelo-ZGTALMELO

    RECRUITING

    Almelo, Netherlands

  • NL-Amstelveen-AMSTELLAND

    RECRUITING

    Amstelveen, Netherlands

  • NL-Apeldoorn-GELREAPELDOORN

    RECRUITING

    Apeldoorn, Netherlands

  • NL-Arnhem-RIJNSTATE

    RECRUITING

    Arnhem, Netherlands

  • NL-Breda-AMPHIA

    RECRUITING

    Breda, Netherlands

  • NL-Delft-RDGG

    RECRUITING

    Delft, Netherlands

  • NL-Den Bosch-JBZ

    RECRUITING

    's-Hertogenbosch, Netherlands

  • NL-Den Haag-HAGA

    RECRUITING

    The Hague, Netherlands

  • NL-Dordrecht-ASZ

    RECRUITING

    Dordrecht, Netherlands

  • NL-Eindhoven-CATHARINA

    RECRUITING

    Eindhoven, Netherlands

  • NL-Eindhoven-MAXIMAMC

    RECRUITING

    Eindhoven, Netherlands

  • NL-Goes-ADRZ

    RECRUITING

    Goes, Netherlands

  • NL-Groningen-MARTINI

    RECRUITING

    Groningen, Netherlands

  • NL-Harderwijk-STJANSDALHARDERWIJK

    RECRUITING

    Harderwijk, Netherlands

  • NL-Hilversum-TERGOOI

    RECRUITING

    Hilversum, Netherlands

  • NL-Hoofddorp-SPAARNEGASTHUIS

    RECRUITING

    Hoofddorp, Netherlands

  • NL-Nieuwegein-ANTONIUS

    RECRUITING

    Nieuwegein, Netherlands

  • NL-Nijmegen-CWZ

    RECRUITING

    Nijmegen, Netherlands

  • NL-Rotterdam-IKAZIA

    RECRUITING

    Rotterdam, Netherlands

  • NL-Schiedam-FRANCISCUSVLIETLAND

    RECRUITING

    Schiedam, Netherlands

  • NL-Sittard-ZUYDERLAND MC

    RECRUITING

    Sittard, Netherlands

  • NL-Sneek-ANTONIUSSNEEK

    RECRUITING

    Sneek, Netherlands

  • NL-Utrecht-UMCUTRECHT

    RECRUITING

    Utrecht, Netherlands

  • NL-Venlo-VIECURI

    RECRUITING

    Venlo, Netherlands

  • NL-Zwolle-ISALA

    RECRUITING

    Zwolle, Netherlands

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