NCT01181999

Rituximab Augmentation Following R-CHOP Induction Chemotherapy in Extremely Elderly Patients With Diffuse Large B Cell Lymphoma

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)

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Chonnam National University Hospital · Academic / Other
• Sex: All
• Age: 70 Years
• Healthy volunteers: Not accepted

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

Conditions

• Lymphoma, Large B-cell, Diffuse

Interventions

Type	Name	Description
DRUG	rituximab	A dose of 375mg/m2 rituximab will be administered intravenously on day 1 of first to fourth R-CHOP chemotherapy and on day 1, 8, 15, 22 of each augmentation chemotherapy.

Timeline

• Start date: 2010-08-01
• Primary completion: 2012-03-01
• Completion: 2014-09-01
• First posted: 2010-08-16
• Last updated: 2011-09-22

Locations

1 site across 1 country: South Korea