Actively Recruiting
Prevention of Anthracycline-Induced Cardiac Dysfunction With Dexrazoxane in Patients With Diffuse Large-B Cell Lymphoma
Led by Stichting Hemato-Oncologie voor Volwassenen Nederland · Updated on 2026-01-05
324
Participants Needed
25
Research Sites
226 weeks
Total Duration
On this page
Sponsors
S
Stichting Hemato-Oncologie voor Volwassenen Nederland
Lead Sponsor
U
UMC Utrecht
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Prevention of Anthracycline-Induced Cardiac Dysfunction With Dexrazoxane in Patients With Diffuse Large-B Cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Untreated patients with confirmed CD20+ DLBCL or related high-grade B-cell lymphomas
- Planned treatment with 6 cycles of R-CHOP21 or allowed similar regimens
- Ann Arbor stage II-IV or stage I with bulky disease (≥10 cm mass) planned for 6 cycles
- Age 18 years or older
- WHO performance status 2 or less, or 3 if related to DLBCL
- Negative pregnancy test for women of childbearing potential
- Women must be post-menopausal, surgically sterile, or use two effective contraception methods or abstain from heterosexual intercourse during study and 12 months after
- Men must use effective barrier contraception or abstain from heterosexual intercourse during study and 12 months after
- Ability to adhere to study visits and protocol
- Provided written informed consent
You will not qualify if you...
- B-cell lymphomas with CNS involvement, testicular DLBCL, primary mediastinal B-cell lymphoma, or EBV post-transplant lymphoproliferative disorder
- Prior or other current malignancies requiring systemic therapy (except DLBCL)
- Requirement for mini-R-CHOP treatment
- Pre-existing cardiac disease including LVEF <50%, symptomatic heart failure, uncontrolled arrhythmias, valvular dysfunction, or cardiomyopathy
- Poor echocardiography imaging quality at baseline
- Severe pulmonary dysfunction unless related to DLBCL
- Severe neurological or psychiatric disease
- Inadequate blood counts unless related to DLBCL
- Significant liver dysfunction unless related to lymphoma
- Active hepatitis B or C infection not controlled as specified
- Significant kidney dysfunction or dialysis
- Active uncontrolled infections
- Known HIV positive status
- Breastfeeding women
- Any condition impairing study compliance
- Participation in another clinical trial with anti-cancer or cardiovascular drugs
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 25 locations
1
NL-Den Bosch-JBZ
's-Hertogenbosch, Netherlands
Actively Recruiting
2
NL-Almelo-ZGTALMELO
Almelo, Netherlands
Actively Recruiting
3
NL-Amstelveen-AMSTELLAND
Amstelveen, Netherlands
Actively Recruiting
4
NL-Apeldoorn-GELREAPELDOORN
Apeldoorn, Netherlands
Actively Recruiting
5
NL-Arnhem-RIJNSTATE
Arnhem, Netherlands
Actively Recruiting
6
NL-Breda-AMPHIA
Breda, Netherlands
Actively Recruiting
7
NL-Delft-RDGG
Delft, Netherlands
Actively Recruiting
8
NL-Dordrecht-ASZ
Dordrecht, Netherlands
Actively Recruiting
9
NL-Eindhoven-CATHARINA
Eindhoven, Netherlands
Actively Recruiting
10
NL-Eindhoven-MAXIMAMC
Eindhoven, Netherlands
Actively Recruiting
11
NL-Goes-ADRZ
Goes, Netherlands
Actively Recruiting
12
NL-Groningen-MARTINI
Groningen, Netherlands
Actively Recruiting
13
NL-Harderwijk-STJANSDALHARDERWIJK
Harderwijk, Netherlands
Actively Recruiting
14
NL-Hilversum-TERGOOI
Hilversum, Netherlands
Actively Recruiting
15
NL-Hoofddorp-SPAARNEGASTHUIS
Hoofddorp, Netherlands
Actively Recruiting
16
NL-Nieuwegein-ANTONIUS
Nieuwegein, Netherlands
Actively Recruiting
17
NL-Nijmegen-CWZ
Nijmegen, Netherlands
Actively Recruiting
18
NL-Rotterdam-IKAZIA
Rotterdam, Netherlands
Actively Recruiting
19
NL-Schiedam-FRANCISCUSVLIETLAND
Schiedam, Netherlands
Actively Recruiting
20
NL-Sittard-ZUYDERLAND MC
Sittard, Netherlands
Actively Recruiting
21
NL-Sneek-ANTONIUSSNEEK
Sneek, Netherlands
Actively Recruiting
22
NL-Den Haag-HAGA
The Hague, Netherlands
Actively Recruiting
23
NL-Utrecht-UMCUTRECHT
Utrecht, Netherlands
Actively Recruiting
24
NL-Venlo-VIECURI
Venlo, Netherlands
Actively Recruiting
25
NL-Zwolle-ISALA
Zwolle, Netherlands
Actively Recruiting
Research Team
A
A. van Rhenen, MD
CONTACT
M
M.P.M. Linschoten, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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