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RATIONALE: Monoclonal antibodies, such as rituximab, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin, vincristine, and prednisone, work in different ways to stop cancer cells from dividing so they stop growing or die. Oblimersen may increase the effectiveness of anticancer drugs by making cancer cells more sensitive to the drugs. Combining rituximab and combination chemotherapy with oblimersen may kill more cancer cells.
PURPOSE: This randomized phase II trial is studying rituximab and combination chemotherapy to see how well they work compared to oblimersen, rituximab, and combination chemotherapy in treating patients with advanced diffuse large B-cell non-Hodgkin's lymphoma.
- Compare the 1-year progression-free survival probability rate in patients with low- or low-intermediate-risk advanced diffuse large B-cell non-Hodgkin's lymphoma treated with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone with or without oblimersen.
- Compare the response (complete, unconfirmed complete, and partial) in patients treated with these regimens.
- Compare the toxicity of these regimens in these patients.
- Compare the 1-year progression-free survival and response rate in a subset of patients overexpressing bcl-2 protein treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age-adjusted International Prognostic Index (0 vs 1). Patients are randomized to 1 of 2 treatment arms. (Arm I closed to accrual as of 9/21/04.)
- Arm I (closed to accrual as of 9/21/04): Patients receive rituximab IV over 6 hours, cyclophosphamide IV over 15-45 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on day 1 and oral prednisone on days 1-5.
- Arm II: Patients receive oblimersen IV continuously on days 1-7; rituximab IV over 6 hours, cyclophosphamide IV over 15-45 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on day 5; and oral prednisone on days 5-10.
In both arms, treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 1 year, every 6 months for 1 year, and then annually for up to 5 years.
PROJECTED ACCRUAL: A total of 160 patients (80 per treatment arm) (arm I closed to accrual as of 9/21/04) will be accrued for this study within 2 years.
Allocation: Randomized, Control: Active Control, Primary Purpose: Treatment
oblimersen sodium, rituximab, cyclophosphamide, doxorubicin hydrochloride, prednisone, vincristine sulfate
Active, not recruiting
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-08-27T03:54:27-0400
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