Rituximab Augmentation Following R-CHOP Induction Chemotherapy in Extremely Elderly Patients With Diffuse Large B Cell Lymphoma
NCT01181999 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2011-09-22
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.
Conditions
- Lymphoma, Large B-cell, Diffuse
Interventions
- DRUG
-
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.
Sponsors & Collaborators
-
Samsung Medical Center
collaborator OTHER -
Asan Medical Center
collaborator OTHER -
Severance Hospital
collaborator OTHER -
Chonnam National University Hospital
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2010-08-31
- Primary Completion
- 2012-03-31
- Completion
- 2014-09-30
Countries
- South Korea
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