R-CHOP + GM-CSF for Previously Untreated LCL in Elderly
Phase 2
Completed
- Conditions
- Lymphoma, Large B-Cell, Diffuse
- Interventions
- Drug: R-CHOP+GM-CSF
- Registration Number
- NCT00582725
- Lead Sponsor
- University of Wisconsin, Madison
- Brief Summary
Patients will receive 6 to 8 cycles of R-CHOP (Rituximab, Cyclophosphamide, doxorubicin, vincristine, and prednisone), with GM-CSF.
- Detailed Description
The objective of this study is to estimate complete response rates for patients treated with this regimen, to assess overall response rates, event-free survival and overall survival; and to assess toxicities associated with R-CHOP + GM-CSF. Patients will receive 6 to 8 cycles of R-CHOP (Rituximab, Cyclophosphamide, doxorubicin, vincristine, and prednisone), with GM-CSF.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 38
Inclusion Criteria
- Histologically confirmed, CD20+ B cell diffuse large cell lymphoma, with measurable or evaluable disease
- Having no prior chemotherapy, immunotherapy or radiotherapy except for one cycle of CHOP or R-CHOP.
Exclusion Criteria
- Pregnant
- Hepatitis B Surface Antigen positive
- Have known CNS disease or HIV infection
- Have NY Classification III or IV disease.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description R-CHOP + GM-CSF R-CHOP+GM-CSF R-CHOP therapy (6-8 cycles) with GM-CSF
- Primary Outcome Measures
Name Time Method Response Rate to Therapy Dec 2005 approx
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University Of Wisconsin
🇺🇸Madison, Wisconsin, United States