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Brief Title: Rituximab Augmentation Following R-CHOP Induction Chemotherapy in Extremely Elderly Patients With Diffuse Large B Cell Lymphoma
Official Title: Phase II Trial of Rituximab (R) Augmentation Following R-CHOP (Cyclophosphamide, Doxorubicin, Vincristine, and Prednisolone) Induction Chemotherapy in Extremely Elderly Patients With Diffuse Large B Cell Lymphoma (DLBCL)
Study ID: NCT01181999
Brief Summary: Rituximab (R) plus CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisolone) combination is considered as the new gold standard for the first-line treatment of elderly patients with diffuse large B-cell lymphoma (DLBCL). The study is aimed to evaluate the overall response rate and the safety of four cycles of R-CHOP chemotherapy and followed by rituximab augmentation (weekly four times infusion) in newly diagnosed DLBCL patients with aged more than 70 years.
Detailed Description: 1. Four cycles of R-CHOP chemotherapy for the induction treatment \[Dose intensity of CHOP chemotherapy is modulated according to Charlson Comorbidity Index (CCI)\] If patients with CCI \<1 * Rituximab: 375 mg/m2, day 1 every 3 weeks. * Conventional dose of CHOP chemotherapy repeat every 3 weeks. If patients with CCI ≥1 * Rituximab: 375 mg/m2, day 1 every 3 weeks. * 75% of conventional CHOP repeat every 3 weeks. 2. Rituximab augmentation * Rituximab: 375 mg/m2, every week x 4 times. * Trimethoprim-sulfamethoxazole 1 tablet per day during augmentation
Minimum Age: 70 Years
Eligible Ages: OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Chonnam National University Hwasun Hosptial, Jeollanam-do, , Korea, Republic of