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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
216
30 mg/m2, IV (in the vein) on day 1 of each 21 day cycle
50 mg/m2, IV (in the vein) on day 1 of each 21 day cycle
375 mg/m2, IV (in the vein) on day 0 of each 21 day cycle
750 mg/m2, IV (in the vein) on day 1 of each 21 day cycle
1.4 mg/m2 (2mg in maxium), IV (in the vein) on day 1 of each 21 day cycle
100mg/d, PO on day 1-5 of each 21 day cycle
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
RECRUITINGNanfang Hospital of Southern Medical Unversity
Guangzhou, Guangdong, China
NOT_YET_RECRUITINGSun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGThe First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
NOT_YET_RECRUITINGThe Second Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
NOT_YET_RECRUITINGThe Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
NOT_YET_RECRUITINGWujing Zongdui Hospital of Guangdong Province
Guangzhou, Guangdong, China
NOT_YET_RECRUITINGevent-free survival (EFS)
Defined as time from the date of randomization to the date of disease progression, death due to any cause, termination of treatment, or the most recent follow-up
Time frame: two year
overall response rate (ORR)
defined as the proportion of patients whose best overall response is either complete remission (CR) or partial remission (PR), which was evaluated in accordance with the International Working Group Recommendations for Response Criteria for non-Hodgkin's lymphoma
Time frame: at week 6, 12, 18, and 24 after randomization
complete remission (CR) rate
defined as the proportion of patients whose best overall response is complete remission, which was evaluated in accordance with the International Working Group Recommendations for Response Criteria for non-Hodgkin's lymphoma
Time frame: at week 6, 12, 18, and 24 after randomization
overall survival (OS)
defined as time from the date of randomization to the date of death due to any cause or the most recent follow-up
Time frame: two year
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