A Phase 3 interventional study of Pegylated liposomal doxorubicin and Doxorubicin in Lymphoma, Large B-Cell, Diffuse, sponsored by Wenqi Jiang. Status unknown at 7 sites in China. Open to participants aged 60 Years to 80 Years. Per ClinicalTrials.gov, last updated 2015-11-18.
Sponsored by Wenqi Jiang · Phase 3, Interventional, and Treatment
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.
1,432 studies on the registry are indexed under Lymphoma, Large B-Cell, Diffuse; 359 are open to participants now.
This study's planned enrollment of 216 is above the median of 47 across 1,214 interventional studies indexed under Lymphoma, Large B-Cell, Diffuse.
Browse Lymphoma, Large B-Cell, Diffuse studies →This is the only study on the registry with Wenqi Jiang as lead sponsor.
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This group received R-CHOP regimen as the first-line chemotherapy. Rituximab, 375mg/m2, iv, d0; Cyclophophamide, 750mg/m2, iv, d1; Doxorubicin, 50mg/m2, iv, d1; Vincristine, 2mg/m2 (max 2mg), iv, d1; Prednisone, 100mg, po, d1-5. Repeat every 21 days for 6-8 cycles or until the criteria of terminating treatment was met.
Drug: Doxorubicin · Drug: Rituximab · Drug: Cyclophophamide · Drug: Vincristine · Drug: Prednisone
This group received R-CDOP regimen as the first-line chemotherapy. Rituximab, 375mg/m2, iv, d0; Cyclophophamide, 750mg/m2, iv, d1; Pegylated liposomal doxorubicin, 30mg/m2, iv, d1; Vincristine, 2mg/m2 (max 2mg), iv, d1; Prednisone, 100mg, po, d1-5. Repeat every 21 days for 6-8 cycles or until the criteria of terminating treatment was met.
Drug: Pegylated liposomal doxorubicin · Drug: Rituximab · Drug: Cyclophophamide · Drug: Vincristine · Drug: Prednisone
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
event-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
This study is status unknown, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Liposomal doxorubicin
Lymphoma, Large B-Cell, Diffuse →