AzTrials
AzTrials

DLBCL - Diffuse Large B Cell LymphomaPhase 3HO170DLBCLNCT06220032

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

A Phase 3 study testing Dexrazoxane, Rituximab and Cyclophosphamide in people with DLBCL - Diffuse Large B Cell Lymphoma, run by Stichting Hemato-Oncologie voor Volwassenen Nederland at 25 sites in Netherlands.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
DLBCL - Diffuse Large B Cell Lymphoma
What is being tested?
Dexrazoxane, Rituximab and Cyclophosphamide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
324 participants
Where
25 sitesNetherlands
Study dates
15 Aug 2024to 15 Dec 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
Show all 22Show fewer
  • 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.
  • 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
  • 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);
  • Age ≥ 18 years;
  • WHO performance status ≤ 2, WHO 3 performance status is allowed when considered directly related to the DLBCL;
  • Negative pregnancy test at study entry for women of childbearing potential;
  • 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;
  • 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;
  • Patient is able to adhere to the study visit schedule and other protocol requirements;
  • Written informed consent.

Who cannot join

  • 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;
Show all 27Show fewer
  • 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.
  • Patients requiring treatment with mini-R-CHOP
  • 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
  • Non-diagnostic/poor transthoracic echocardiography imaging quality at baseline;
  • Severe pulmonary dysfunction defined as breathlessness at rest (COPD GOLD III or IV), unless clearly related to DLBCL;
  • Severe neurological or psychiatric disease;
  • Inadequate hematological function (absolute Neutrophil Count (ANC) <1.0x109/L or platelets <75x109/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;
  • 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;
  • Significant renal dysfunction (creatinine clearance < 30 ml/min after rehydration) or requiring dialysis;
  • Active uncontrolled fungal, bacterial and/or viral infection;
  • Patient known to be HIV-positive;
  • Breast-feeding female patients;
  • Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule;
  • Participation in another clinical trial with anti-cancer therapy or a cardiovascular drug.

Trial locations and contacts

25 sites in 1 country. Contact the study team or a site near you to ask about taking part.

A. van Rhenen, MD contact

+31 107041560

A.vanRhenen@umcutrecht.nl

M.P.M. Linschoten, MD contact

m.p.m.linschoten@amsterdamumc.nl

25 sites in 1 country

Netherlands25 sites, 25 recruiting

  • NL-Den Bosch-JBZ

    's-Hertogenbosch

    Recruiting

  • NL-Almelo-ZGTALMELO

    Almelo

    Recruiting

  • NL-Amstelveen-AMSTELLAND

    Amstelveen

    Recruiting

  • NL-Apeldoorn-GELREAPELDOORN

    Apeldoorn

    Recruiting

  • NL-Arnhem-RIJNSTATE

    Arnhem

    Recruiting

  • NL-Breda-AMPHIA

    Breda

    Recruiting

  • NL-Delft-RDGG

    Delft

    Recruiting

  • NL-Dordrecht-ASZ

    Dordrecht

    Recruiting

  • NL-Eindhoven-CATHARINA

    Eindhoven

    Recruiting

  • NL-Eindhoven-MAXIMAMC

    Eindhoven

    Recruiting

  • NL-Goes-ADRZ

    Goes

    Recruiting

  • NL-Groningen-MARTINI

    Groningen

    Recruiting

  • NL-Harderwijk-STJANSDALHARDERWIJK

    Harderwijk

    Recruiting

  • NL-Hilversum-TERGOOI

    Hilversum

    Recruiting

  • NL-Hoofddorp-SPAARNEGASTHUIS

    Hoofddorp

    Recruiting

  • NL-Nieuwegein-ANTONIUS

    Nieuwegein

    Recruiting

  • NL-Nijmegen-CWZ

    Nijmegen

    Recruiting

  • NL-Rotterdam-IKAZIA

    Rotterdam

    Recruiting

  • NL-Schiedam-FRANCISCUSVLIETLAND

    Schiedam

    Recruiting

  • NL-Sittard-ZUYDERLAND MC

    Sittard

    Recruiting

  • NL-Sneek-ANTONIUSSNEEK

    Sneek

    Recruiting

  • NL-Den Haag-HAGA

    The Hague

    Recruiting

  • NL-Utrecht-UMCUTRECHT

    Utrecht

    Recruiting

  • NL-Venlo-VIECURI

    Venlo

    Recruiting

  • NL-Zwolle-ISALA

    Zwolle

    Recruiting

Other trials in Netherlands

About this study

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

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.

Read the detailed description

HO170 DLBCL-ANTICIPATE: "Prevention of ANThracycline-Induced Cardiac dysfunction by dexrazoxane In PATients with diffusE large B-cell lymphoma" is a national randomized controlled trial that will be conducted across 25 Dutch hospitals. This study will include adult patients with DLBCL in which first-line treatment with 6 cycles of R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone) is planned (cumulative doxorubicin dose 300 mg/m2). In this trial, we have chosen to include patients with a normal cardiac function before chemotherapy because cardiac dysfunction is a contra-indication for administration of anthracyclines. A total of 324 DLBCL patients will prior to treatment be randomized in a 1:1 ratio to either (1) intravenous dexrazoxane administration in a 10:1 dexrazoxane:doxorubicin ratio prior to each doxorubicin infusion or (2) no cardioprotective treatment (current standard of care). Due to the low pH of the dexrazoxane solution that would jeopardize the blinding no placebo is used. Cardiac function will be screened with echocardiography prior to the initiation of chemotherapy and followed-up at 4- and 12-months post randomization. The primary end point of the study will be the incidence of AICD, defined as a left ventricular ejection fraction (LVEF) decline of ≥10 percentage points from baseline and below 50% (normal reference value for two-dimensional (2D) echocardiography). The secondary endpoint will be the percentage of patients with complete metabolic remission (CMR) after R-CHOP chemotherapy, to reassure that dexrazoxane does not influence the antineoplastic efficacy of doxorubicin. To declare ANTICIPATE successful, the trial must show both the superiority of addition of dexrazoxane on the primary endpoint and non-inferiority on the secondary endpoint. Deep-phenotyping of patient- and treatment-related factors will be performed to evaluate their prognostic value.

Keywords
dexrazoxane, primary prevention, cardiotoxicity, heart failure, diffuse large B-cell lymphoma, R-CHOP, FL, R2CHOP, LVEF
Medical subject headings
Dendritic Cell Sarcoma, Interdigitating, Cardiotoxicity, Heart Failure, Lymphoma, Large B-Cell, Diffuse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DexrazoxaneDrug

    Also called Cardioxane

    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.

  • RituximabDrug

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

  • CyclophosphamideDrug

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

  • DoxorubicinDrug

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

  • VincristineDrug

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

  • PrednisoloneDrug

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

  • LenalidomideDrug

    Also called Revlimid

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

  • PegfilgrastimDrug

    Also called Pegfilgastim

    6 mg (1 dose per cycle) in case of neutropenia. Pegfilgastim is mandatory in patients that receive R2-CHOP21.

Study groups in NCT06220032
Study groupRoleWhat they receive
Arm AExperimentalStandard R-CHOP 21 treatment regimen: 6 cycles R-CHOP 21 (rituximab*, cyclophosphamide, doxorubicin, vincristine, prednisolone) *The use of a biosimilar is allowed.
Receives: Drug: Rituximab; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Vincristine; Drug: Prednisolone; Drug: Lenalidomide; Drug: Pegfilgrastim
Arm B -ExperimentalAddition of the cardioprotectant dexrazoxane to the R-CHOP 21 regimen: R-CHOP21 (rituximab*, cyclophosphamide, doxorubicin, vincristine, prednisolone plus dexrazoxane). *The use of a biosimilar is allowed.
Receives: Drug: Dexrazoxane; Drug: Rituximab; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Vincristine; Drug: Prednisolone; Drug: Lenalidomide; Drug: Pegfilgrastim

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The incidence of AICD.

    The incidence of AICD (measured with 2D) within 12 months after registration is reported in the eCRF.

    Measured: 12 months after LPI

Secondary outcomes (7)

  1. Complete Metabolic Remission.

    Complete metabolic remission (CMR) on 18F-FDG PET-CT at end of treatment 6-8 weeks after completion of 6x R-CHOP21 is reported in the eCRF.

    Measured: 12 months after LPI

  2. Overall survival (OS).

    Overall survival (OS) at 12-months is reported in the eCRF.

    Measured: 12 months after LPI

  3. Progression-free survival.

    Progression-free survival (PFS) at 12-months is reported in the eCRF.

    Measured: 12 months after LPI

  4. LVEF and global longitudinal strain (GLS).

    LVEF (2D and 3D) and global longitudinal strain (GLS) at end of treatment and 12-months after start of treatment is reported in the eCRF.

    Measured: 12 months after LPI

  5. NYHA.

    NYHA functional class is reported in the eCRF.

    Measured: 12 months after LPI

  6. Cardiac biomarkers.

    Release of cardiac biomarkers. At entry, after every cyle of R-CHOP, at EOT and FU. CK (if available); CK-MB (if available) \& (hs)Troponin T/I (assay according to local practice). Items are reported in the eCRF.

    Measured: 12 months after LPI

  7. Quality of Life.

    To analyse the impact of the addition of dexrazoxane on QoL via validated questionaires such as QLQ-C30, NHL-HG29, PRO-CTCAE. Data are collected.

    Measured: 12 months after LPI

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jan 2024
  2. Study start15 Aug 2024
  3. Primary completion15 Dec 2028 (estimated)
  4. Study completion15 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
324 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06220032
Sponsor's protocol ID
HO170 DLBCL-ANTICIPATE
Other IDs
2023-505377-32, 2023
Acronym
HO170DLBCL
Status last verified
Oct 2025
First submitted
11 Jan 2024
Last updated
23 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: According to the current publication policy the protocol and Statistical Analysis Plan (SAP) will be shared. The Principal Investigators can be contacted for IPD sharing after the publication of the study results. According to the 'HOVON Sample and/or Data request Form' the HOVON director; chair of the lymphoma working group, the study PI and Coordinating Investigator should approve data/sample sharing.

Publications

  • Linschoten M, Geels J, van Werkhoven E, Visser-Wisselaar H, Chamuleau MED, Teske AJ, Robbers L, Oerlemans S, Crommelin H, Breems-de Ridder M, Schut A, Asselbergs FW, van Rhenen A; HOVON 170 DLBCL - ANTICIPATE consortium. Rationale and design of the HOVON 170 DLBCL-ANTICIPATE trial: preventing anthracycline-induced cardiac dysfunction with dexrazoxane. Cardiooncology. 2025 Jan 28;11(1):8. doi: 10.1186/s40959-025-00303-y.

    PubMed 39875951

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dexrazoxane, Rituximab and Cyclophosphamide in people with DLBCL - Diffuse Large B Cell Lymphoma, run by Stichting Hemato-Oncologie voor Volwassenen Nederland at 25 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact A. van Rhenen, MD (+31 107041560, A.vanRhenen@umcutrecht.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The incidence of AICD. (time frame: 12 months after LPI). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06220032, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in