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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
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving rituximab together with combination chemotherapy may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving rituximab together with combination chemotherapy works in treating older patients with diffuse large B-cell lymphoma.
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.
Age
61 - No limit years
Sex
ALL
Healthy Volunteers
No
Hembree Mercy Cancer Center at St. Edward Mercy Medical Center
Fort Smith, Arkansas, United States
CCOP - Grand Rapids
Grand Rapids, Michigan, United States
CCOP - Kalamazoo
Kalamazoo, Michigan, United States
Cancer Research for the Ozarks
Springfield, Missouri, United States
Hematology Oncology Associates of Central New York, PC - Northeast Center
East Syracuse, New York, United States
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States
University of Texas M.D. Anderson CCOP Research Base
Houston, Texas, United States
Start Date
September 1, 2005
Primary Completion Date
September 1, 2014
Completion Date
September 1, 2014
Last Updated
October 19, 2020
80
ACTUAL participants
Filgrastim
BIOLOGICAL
Pegfilgrastim
BIOLOGICAL
Rituximab
BIOLOGICAL
Cyclophosphamide
DRUG
Pegylated liposomal doxorubicin hydrochloride
DRUG
Prednisone
DRUG
Vincristine Sulfate
DRUG
Lead Sponsor
M.D. Anderson Cancer Center
Collaborators
NCT06337318
NCT07388563
Data Source & Attribution
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