NCT02428751

R-CHOP Versus R-CDOP as First-line Treatment for Elderly Patients With Diffuse Large-B-cell Lymphoma

Rituximab, Cyclophosphamide, Vincristine, and Prednisone in Combination With Doxorubicin (R-CHOP) Versus in Combination With Pegylated-liposomal Doxorubicin (R-CDOP) as First-line Treatment for Elderly Patients With Diffuse Large-B-cell Lymphoma: a Randomised, Multicentre, Non-inferiority Study

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 216 (estimated)
• Sponsor: Wenqi Jiang · Academic / Other
• Sex: All
• Age: 60 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lymphoma, Large B-Cell, Diffuse

Interventions

Type	Name	Description
DRUG	Pegylated liposomal doxorubicin	30 mg/m2, IV (in the vein) on day 1 of each 21 day cycle
DRUG	Doxorubicin	50 mg/m2, IV (in the vein) on day 1 of each 21 day cycle
DRUG	Rituximab	375 mg/m2, IV (in the vein) on day 0 of each 21 day cycle
DRUG	Cyclophophamide	750 mg/m2, IV (in the vein) on day 1 of each 21 day cycle
DRUG	Vincristine	1.4 mg/m2 (2mg in maxium), IV (in the vein) on day 1 of each 21 day cycle
DRUG	Prednisone	100mg/d, PO on day 1-5 of each 21 day cycle

Timeline

• Start date: 2015-09-01
• Primary completion: 2020-03-01
• Completion: 2020-05-01
• First posted: 2015-04-29
• Last updated: 2015-11-18

Locations

7 sites across 1 country: China