Study in Patients With Primary Breast Diffuse Large B-cell Lymphoma
- Sponsor
- Chonbuk National University Hospital
- Study ID
- NCT01448096
- Phase
- PHASE2
- Status
- Completed
Conditions
- Large B Cell Diffuse Lymphoma
Eligibility Criteria
- Sex
- FEMALE
- Age
- 20 Years - 75 Years
- Healthy Volunteers
- Not accepted
Interventions
- Rituximab — DRUGR-CHOP21 consist of rituximab (375 mg/m2), cyclophosphamide (750 mg/m2), doxorubicin (50 mg/m2), and vincristine (1.4 mg/m2, a maximum of 2mg), administered intravenously on day 1 and 100 mg oral prednisone on days 1 through 5.
- Prophylactic intrathecal chemotherapy — PROCEDUREProphylactic intrathecal chemotherapy using methotrexate (12mg total dose) will be performed
Study Details
The purpose of this study is to clarify the impact of rituximab on clinical outcomes in patients with primary breast diffuse large B-cell lymphoma and also to investigate the role of prophylactic intrathecal chemotherapy using methotrexate for reducing central nervous system (CNS) recurrence.
Key Dates
- Start date
- Aug 31, 2011
- Status verified
- Aug 2019
- Primary completion
- Jul 10, 2019
- Completion
- Jul 10, 2019
Study Design
- Enrollment
- 33 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: primary breast DLBCLisolated breast involvement with or without nodal disease
Primary Outcome Measure
progression-free survival [ Time Frame: From the date of treatment until the date of disease progression or death from any cause (minimum 2 years) ]