A Phase II Study Of Rituximab-CHOP With Pegylated Liposomal Doxorubicin In Patients Older Than 60 Years Of Age With Untreated Aggressive B-Cell Non-Hodgkin's Lymphoma
- 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
- Determine the cardiotoxicity and myelosuppression of this regimen in these patients.
- Determine disease-free survival and overall survival of patients treated with this
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.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Disease response (complete, complete unconfirmed, and partial responses) after courses 4 and 8
Up to 24 weeks (8 cycles of 21 days)
Maria A. Rodriguez, MD
M.D. Anderson Cancer Center
United States: Federal Government
|CCOP - Upstate Carolina||Spartanburg, South Carolina 29303|
|CCOP - Kalamazoo||Kalamazoo, Michigan 49007-3731|
|Cancer Research for the Ozarks||Springfield, Missouri 65807|
|CCOP - Grand Rapids||Grand Rapids, Michigan 49503|
|Hembree Mercy Cancer Center at St. Edward Mercy Medical Center||Ft. Smith, Arkansas 72903|
|University of Texas M.D. Anderson CCOP Research Base||Houston, Texas 77030-4009|
|Hematology Oncology Associates of Central New York, PC - Northeast Center||East Syracuse, New York 13057-4510|