R-CHOP + GM-CSF for Previously Untreated LCL in Elderly

Phase II Trial of Rituximab-CHOP (R-CHOP) Plus GM-CSF for Previously Untreated Diffuse Large Cell Lymphoma in the Elderly

Patients will receive 6 to 8 cycles of R-CHOP (Rituximab, Cyclophosphamide, doxorubicin, vincristine, and prednisone), with GM-CSF.

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.

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.