Recurrent Mantle Cell Lymphoma Clinical Trial
Official title:
A Phase II Study of G3139 (Bcl-2 Antisense) And Rituximab in Patients With Recurrent B-cell Non-Hodgkinâs Lymphomas
The goal of this clinical research study is to learn if the combination of oblimersen sodium and rituximab can help to shrink or slow the growth of the tumor in patients with B-cell non-Hodgkin's lymphoma who have not responded to earlier treatment. Oblimersen Sodium is an investigational drug. The safety of this combination treatment will also be studied
PRIMARY OBJECTIVES:
I. To determine the therapeutic efficacy and toxicity of G3139 (oblimersen sodium) and
Rituximab in patients with recurrent B-cell NHL.
SECONDARY OBJECTIVES:
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.
OUTLINE:
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.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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