Finding studies
Finding studies
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Lead
National Cancer Institute (NCI)
PRIMARY OBJECTIVES: I. To determine the response rate (overall and complete response rate) after rituximab + oblimersen sodium extended induction therapy in previously untreated cluster of differentiation 20 positive (CD20+) follicular non-Hodgkin lymphoma (NHL) patients. II. To determine the time to progression after rituximab + oblimersen sodium extended induction therapy in previously untreated CD20+ follicular NHL patients. SECONDARY OBJECTIVES: I. To determine the toxicity profile of rituximab + oblimersen sodium therapy in previously untreated CD20+ follicular NHL patients. II. To establish whether the therapeutic effects of the rituximab + oblimersen sodium combination are sufficiently promising to warrant evaluation in a subsequent randomized trial (in comparison to rituximab alone). III. To correlate Fc receptor profiling to response to rituximab + oblimersen sodium in previously untreated patients with follicular NHL. IV. To determine the relationship between change in fludeoxyglucose F 18 (FDG) uptake early after treatment with rituximab + oblimersen sodium to response rate and time to progression. OUTLINE: This is a multicenter study. Induction therapy (month 1): Patients receive oblimersen IV continuously on days 1-7 and 15-21 and rituximab IV on days 3, 10, 17, and 24 in month 1. Extended induction therapy (months 3, 5, 7, and 9): Patients receive oblimersen IV continuously on days 22-28 and rituximab IV on day 24 in months 3, 5, 7, and 9. Treatment continues for 9 months in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed periodically for up to 10 years. PROJECTED ACCRUAL: A total of 52 patients will be accrued for this study.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
