Beth Israel Deaconess Medical Center
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
This phase II, multicenter, randomized, double-blind, double-dummy 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. Participants will be assigned by the study doctor to standard of care R-CHOP or standard of care pola-R-CHP therapy regimens. R-CHOP Participants will be randomized into 1 of 2 study groups: Group A: Dexrazoxane, cyclophosphamide, doxorubicin, vincristine, prednisone,…
Inclusion Criteria: * Participants must have histologically confirmed diffuse large B-cell lymphoma, histologically transformed large B cell lymphoma from a prior indolent lymphoma, or other high-grade B-cell lymphoma for which R-CHOP or pola-R-CHP are planned. Any cancer stage is permitted. * Participants must not have received any prior chemotherapy for this malignancy. Pre-phase steroids are allowed. Prior treatment for a different malignancy is allowed, including prior treatment for indolent lymphoma. * Age ≥18 years. Diffuse large B cell lymphoma is rare in participants \<18 years of age…
Topoisomerase II Inhibitor, single-dose vial, via intravenous infusion per protocol.
Dexrazoxane placebo via intravenous infusion per protocol.
Topoisomerase II Inhibitors, single-dose vial, via intravenous infusion per protocol.
Topoisomerase II Inhibitors, single-dose vial, via intravenous infusion per protocol.
Lymphodepleting chemotherapy, multi-dose vial, via intravenous infusion per standard of care.
vinca alkaloid, single-dose vial, via intravenous infusion per standard of care.
Glucocorticoid, tablet taken orally per standard of care.
Anti-CD20 antibody, single-use vials, via intravenous infusion per standard of care.
CD79b-directed antibody-drug conjugate, single-dose vial, via intravenous infusion per standard of care.
Arctuva estimate
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