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NOT YET RECRUITING
NCT07654426
PHASE2

The CARDIOPROTECT Trial

Sponsor: Beth Israel Deaconess Medical Center

View on ClinicalTrials.gov

Summary

This trial is to evaluate if dexrazoxane is safer and more effective than liposomal doxorubicin in preventing heart failure events in participants with diffuse large B-cell lymphoma (DLBCL) undergoing either standard of care R-CHOP or pola-R-CHP treatment regiments. The names of the study drugs involved in this study are: * Dexrazoxane (a type of Topoisomerase II Inhibitor) * Liposomal Doxorubicin (a type of Topoisomerase II Inhibitor) * Standard of care R-CHOP treatment regimen (Cyclophosphamide, doxorubicin, vincristine, prednisone, rituximab) * Standard of care pola-R-CHP treatment regimen: Cyclophosphamide, doxorubicin, polatuzumab vedotin-piiq, prednisone, rituximab

Official title: A Randomized Study of Dexrazoxane or Liposomal Doxorubicin in Newly Diagnosed Diffuse Large B-cell Lymphoma at High Risk for Heart Failure Events: the CARDIOPROTECT Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2026-10-02

Completion Date

2035-12-31

Last Updated

2026-06-17

Healthy Volunteers

No

Interventions

DRUG

Dexrazoxane

Topoisomerase II Inhibitor, single-dose vial, via intravenous infusion per protocol.

DRUG

Dexrazoxane placebo

Dexrazoxane placebo via intravenous infusion per protocol.

DRUG

Doxorubicin

Topoisomerase II Inhibitors, single-dose vial, via intravenous infusion per protocol.

DRUG

Liposomal Doxorubicin

Topoisomerase II Inhibitors, single-dose vial, via intravenous infusion per protocol.

DRUG

Cyclophosphamide

Lymphodepleting chemotherapy, multi-dose vial, via intravenous infusion per standard of care.

DRUG

Vincristine

vinca alkaloid, single-dose vial, via intravenous infusion per standard of care.

DRUG

Prednisone

Glucocorticoid, tablet taken orally per standard of care.

DRUG

Rituximab

Anti-CD20 antibody, single-use vials, via intravenous infusion per standard of care.

DRUG

Polatuzumab Vedotin

CD79b-directed antibody-drug conjugate, single-dose vial, via intravenous infusion per standard of care.

Locations (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States