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The CARDIOPROTECT Trial
Sponsor: Beth Israel Deaconess Medical Center
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
Dexrazoxane
Topoisomerase II Inhibitor, single-dose vial, via intravenous infusion per protocol.
Dexrazoxane placebo
Dexrazoxane placebo via intravenous infusion per protocol.
Doxorubicin
Topoisomerase II Inhibitors, single-dose vial, via intravenous infusion per protocol.
Liposomal Doxorubicin
Topoisomerase II Inhibitors, single-dose vial, via intravenous infusion per protocol.
Cyclophosphamide
Lymphodepleting chemotherapy, multi-dose vial, via intravenous infusion per standard of care.
Vincristine
vinca alkaloid, single-dose vial, via intravenous infusion per standard of care.
Prednisone
Glucocorticoid, tablet taken orally per standard of care.
Rituximab
Anti-CD20 antibody, single-use vials, via intravenous infusion per standard of care.
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