R-CHOP Versus R-CDOP as First-line Treatment for Elderly Patients With Diffuse Large-B-cell Lymphoma
Status:
Unknown status
Trial end date:
2020-05-01
Target enrollment:
Participant gender:
Summary
The combination of rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone
(R-CHOP regimen) has been the first-line chemotherapy for elderly patients with diffuse large
B-cell lymphoma (DLBCL). The treatment-related toxicities, especially the severe cardiac
toxicities induced by anthracycline drugs (doxorubicin), have become a major concern among
elderly patients. Pegylated liposomal doxorubicin is a formulation of doxorubicin with a
prolonged circulation time and unique toxicity profile. Previous single arm studies of
elderly patients with lymphoma used pegylated liposomal doxorubicin instead of traditional
doxorubicin in combination with rituximab, cyclophosphamide, vincristine, and prednisone (the
novel R-CDOP regimen), and demonstrated better safety profile, including less bone marrow
suppression and less cardiac toxicities, while maintaining the efficacy. However, the
efficacy and safety of these two regimens (R-CHOP and R-CDOP) have not been head-to-head
compared in a randomized study. The aim of this study is to compare the efficacy and safety
of R-CDOP (rituximab, cyclophosphamide, pegylated liposomal doxorubicin, vincristine, and
prednisone) and R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and
prednisone) in previously untreated elderly patients with DLBCL.