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)
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
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
the overall response rate
To evaluate the objective overall response rate of four cycles of R-CHOP and followed by four times weekly rituximab augmentation in exteremely elderly patients with DLBCL.
three years after the completion of rituximab augmentation
Yes
Korea:Korean Food and Drug Administration (KFDA)
ML25393
NCT01181999
August 2010
September 2014
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