NCT06220032View on ClinicalTrials.gov

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

PHASE3RecruitingINTERVENTIONAL
Enrollment

324

Participants

Timeline

Start Date

August 15, 2024

Primary Completion Date

December 15, 2028

Study Completion Date

December 15, 2028

Conditions
DLBCL - Diffuse Large B Cell Lymphoma
Interventions
DRUG

Dexrazoxane

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.

DRUG

Rituximab

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

DRUG

Cyclophosphamide

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

DRUG

Doxorubicin

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

DRUG

Vincristine

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

DRUG

Prednisolone

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

DRUG

Lenalidomide

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

DRUG

Pegfilgrastim

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

Trial Locations (25)

Unknown

RECRUITING

NL-Den Bosch-JBZ, 's-Hertogenbosch

NOT_YET_RECRUITING

NL-Almelo-ZGTALMELO, Almelo

NOT_YET_RECRUITING

NL-Amstelveen-AMSTELLAND, Amstelveen

NOT_YET_RECRUITING

NL-Apeldoorn-GELREAPELDOORN, Apeldoorn

NOT_YET_RECRUITING

NL-Arnhem-RIJNSTATE, Arnhem

NOT_YET_RECRUITING

NL-Breda-AMPHIA, Breda

NOT_YET_RECRUITING

NL-Delft-RDGG, Delft

NOT_YET_RECRUITING

NL-Dordrecht-ASZ, Dordrecht

NOT_YET_RECRUITING

NL-Eindhoven-CATHARINA, Eindhoven

NOT_YET_RECRUITING

NL-Eindhoven-MAXIMAMC, Eindhoven

NOT_YET_RECRUITING

NL-Goes-ADRZ, Goes

NOT_YET_RECRUITING

NL-Groningen-MARTINI, Groningen

NOT_YET_RECRUITING

NL-Harderwijk-STJANSDALHARDERWIJK, Harderwijk

NOT_YET_RECRUITING

NL-Hilversum-TERGOOI, Hilversum

NOT_YET_RECRUITING

NL-Hoofddorp-SPAARNEGASTHUIS, Hoofddorp

NOT_YET_RECRUITING

NL-Nieuwegein-ANTONIUS, Nieuwegein

NOT_YET_RECRUITING

NL-Nijmegen-CWZ, Nijmegen

NOT_YET_RECRUITING

NL-Rotterdam-IKAZIA, Rotterdam

NOT_YET_RECRUITING

NL-Schiedam-FRANCISCUSVLIETLAND, Schiedam

NOT_YET_RECRUITING

NL-Sittard-ZUYDERLAND MC, Sittard

NOT_YET_RECRUITING

NL-Sneek-ANTONIUSSNEEK, Sneek

NOT_YET_RECRUITING

NL-Den Haag-HAGA, The Hague

RECRUITING

NL-Utrecht-UMCUTRECHT, Utrecht

NOT_YET_RECRUITING

NL-Venlo-VIECURI, Venlo

NOT_YET_RECRUITING

NL-Zwolle-ISALA, Zwolle

All Listed Sponsors
collaborator

UMC Utrecht

OTHER

collaborator

Amsterdam University Medical Centers

UNKNOWN

collaborator

The Dutch Network for Cardiovascular Research (WCN)

UNKNOWN

lead

Stichting Hemato-Oncologie voor Volwassenen Nederland

OTHER