MedTrace Logo

The CARDIOPROTECT Trial

NCT07654426 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-07-27

No results posted yet for this study

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

Conditions

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.

Sponsors & Collaborators

Principal Investigators

  • Jenica Upshaw, MD, MSc · Beth Israel Deaconess Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-31
Primary Completion
2030-12-31
Completion
2035-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07654426 on ClinicalTrials.gov