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HOVON 170 DLBCL: ANTICIPATE: Prevention of ANThracycline-Induced Cardiac dysfunction by dexrazoxane In PATients with diffusE large B-cell lymphoma: a phase III national multicenter prospective randomized phase III trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-505377-32-00
Enrollment
324
Registered
2024-05-13
Start date
2024-08-15
Completion date
Unknown
Last updated
2025-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diffuse large B-cell lymphoma (DLBCL)

Brief summary

The incidence of AICD (measured with 2D) within 12-months after registration., Complete metabolic remission (CMR) on 18F-FDG PET-CT at end of treatment 6-8 weeks after completion of 6x R-CHOP21.

Detailed description

Overall survival (OS) at 12-months., Progression-free survival (PFS) at 12-months., LVEF (2D and 3D) and global longitudinal strain (GLS) at end of treatment and 12-months after start of treatment., NYHA functional class., Release of cardiac biomarkers., Quality of Life score., Safety and toxicity as defined by type, frequency and severity of adverse events as defined by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0., Incidence of secondary malignancies., Major Adverse Cardiovascular Events (MACE) at 1-, 2-, 5- and 10-years.

Interventions

DRUGLENALIDOMIDE
DRUGCYCLOPHOSPHAMIDE
DRUGPEGFILGRASTIM
DRUGDOXORUBICIN HYDROCHLORIDE
DRUGCardioxane 500 mg poeder voor oplossing voor infusie.
DRUGVINCRISTINE SULFATE
DRUGRITUXIMAB
DRUGPREDNISOLONE
DRUGVINCRISTINE
DRUGDOXORUBICIN

Sponsors

Stichting Hemato-Oncologie voor Volwassenen Nederland (Hovon)
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
The incidence of AICD (measured with 2D) within 12-months after registration., Complete metabolic remission (CMR) on 18F-FDG PET-CT at end of treatment 6-8 weeks after completion of 6x R-CHOP21.—

Secondary

MeasureTime frame
Overall survival (OS) at 12-months., Progression-free survival (PFS) at 12-months., LVEF (2D and 3D) and global longitudinal strain (GLS) at end of treatment and 12-months after start of treatment., NYHA functional class., Release of cardiac biomarkers., Quality of Life score., Safety and toxicity as defined by type, frequency and severity of adverse events as defined by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0., Incidence of secondary malignancies., Major Adverse Cardiovascular Events (MACE) at 1-, 2-, 5- and 10-years.—

Countries

Netherlands

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026