Rituximab and Combination Chemotherapy in Treating Older Patients With Diffuse Large B-Cell Lymphoma

• Disease response (complete, complete unconfirmed, and partial responses) after courses 4 and 8 [ Time Frame: Up to 24 weeks (8 cycles of 21 days) ] [ Designated as safety issue: No ]
  
• Cardiac toxicity as measured by LVEF on ECHO after courses 4 and 8 [ Time Frame: Up to 24 weeks (8 cycles of 21 days) ] [ Designated as safety issue: Yes ]
  

• Survival Rate [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  The percentage of participants still alive after treatment. Survival information obtained 1 month after completion of treatment, then every 3 months for 1 year, every 4 months for one year and every 6 months thereafter.
  
  
• Disease-free survival [ Time Frame: Up to 5 years or until disease progression ] [ Designated as safety issue: No ]
  The percentage of participants with no disease progression for period of time after treatment. Survival assessed every 3 months for 1 year, every 4 months for 2 years, every 6 months for 3 years, and then yearly thereafter up to 5 years.
  
  

OBJECTIVES:

Primary

• Determine the clinical response rate in older patients with previously untreated aggressive diffuse large B-cell stage II-IV lymphoma treated with rituximab, cyclophosphamide, pegylated doxorubicin hydrochloride liposome (HCl), vincristine, and prednisone.
• Determine the cardiotoxicity and myelosuppression of this regimen in these patients.

Secondary

• Determine disease-free survival and overall survival of patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive rituximab intravenous (IV), cyclophosphamide IV over 1-1½ hours, pegylated doxorubicin HCl liposome IV over 1 hour, and vincristine IV on day 1, and oral prednisone on days 1-5. Patients also receive filgrastim (G-CSF) subcutaneously (SC) once daily beginning on day 6 and continuing until blood counts recover OR pegfilgrastim SC once on day 6 (24 hours after the completion of chemotherapy). Treatment repeats every 21 days for up to 8 courses in the absence of unacceptable toxicity, disease progression, active hepatitis B virus infection, or hepatitis. Patients with no response OR who achieve less than a partial response after 4 courses are removed from the study.

Patients are followed at 1 month, every 3 months for 1 year, every 4 months for 1 year, and then every 6 months thereafter.

PROJECTED ACCRUAL: A maximum of 80 patients will be accrued for this study within 27 months.