A Phase II Trial of Rituximab + Oblimersen Sodium (GenasenseTM, G3139, NSC #683428, IND #58842) in Patients With Previously Untreated Follicular Non-Hodgkin Lymphoma (NHL)
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.
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
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.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall response (OR) rate defined as achievement of a complete (CR) or partial response (PR) as the best observed response
The true OR rate will be estimated using the uniformly minimum unbiased estimator. Jennison and Turnbull's method will be used to obtain 95% exact confidence interval for the true OR rate of each arm reflecting the above two-stage design.
Cancer and Leukemia Group B
United States: Food and Drug Administration
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