A Phase II Study of G3139 (Bcl-2 Antisense) And Rituximab in Patients With Recurrent B-cell Non-Hodgkinâs Lymphomas
I. To determine the therapeutic efficacy and toxicity of G3139 (oblimersen sodium) and
Rituximab in patients with recurrent B-cell NHL.
I. To determine the effect of G3139 and Rituximab on the level of Bcl-2 expression.
II. The secondary objective of this study is to evaluate the effect of G3139 and Rituximab
on Bcl-2 protein gene expression.
Patients receive oblimersen sodium intravenously (IV) continuously on days 1-7, 15-21, and
29-35 and rituximab IV over 4-6 hours on days 3, 8, 15, 22, 29, and 36. Patients achieving
stable disease or objective response may receive one additional course of treatment.
After completion of study treatment, patients are followed up every 3 months.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Patients With Objective Response
Efficacy as measured by objective response complete (CR) and partial (PR) response rates at 2 months following study treatment
2 months following study treatment
M.D. Anderson Cancer Center
United States: Food and Drug Administration
|M D Anderson Cancer Center||Houston, Texas 77030|