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

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

Description

Eligibility

Age range

18+ years

Sex

All

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.

Location