Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Jenica Upshaw, MD, MSc
CONTACT
Lead
Beth Israel Deaconess Medical Center
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, rituximab versus Group B: Placebo, cyclophosphamide, liposomal doxorubicin, vincristine, prednisone, rituximab. Participants will have an equal chance of being placed into one of those study groups. Pola-R-CHP participants will be randomized into 1 of 2 study groups: Group C: Dexrazoxane, cyclophosphamide, doxorubicin, polatuzumab vedotin-piiq, prednisone, rituximab versus Group D: Placebo, cyclophosphamide, liposomal doxorubicin, polatuzumab vedotin-piiq, prednisone, rituximab. Participants will have an equal chance of being placed into one of those study groups. Randomization means a participant is placed into a study group by chance. Neither a participant or the study doctor will choose or know what group a participant is placed in. This is called a "double-blind" study. The research study procedures include screening for eligibility, in-clinic visits, questionnaires, blood tests, urine tests, electrocardiograms (ECGs), and echocardiograms (ECHO). The U.S. Food and Drug Administration (FDA) has not approved dexrazoxane for DLBCL. The FDA has not approved liposomal doxorubicin for DLBCL. The FDA has approved all the drugs in R-CHOP as a treatment option for DLBCL. The FDA has approved all the drugs in pola-R-CHP as a treatment option for DLBCL It is expected that about 60 people will take part in this research study. The National Cancer Institute is sponsoring this study by providing funding.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
