Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00054639
Status:
COMPLETED
Last Update Posted:
2014-05-28
First Post:
2003-02-05
Brief Title:
Oblimersen Sodium and Rituximab in Treating Patients With Recurrent B-cell Non-Hodgkin Lymphoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study of G3139 Bcl-2 Antisense And Rituximab in Patients With Recurrent B-cell Non-Hodgkinâs Lymphomas
Status:
COMPLETED
Status Verified Date:
2013-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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-Hodgkins lymphoma who have not responded to earlier treatment Oblimersen Sodium is an investigational drug The safety of this combination treatment will also be studied
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| N01CM62203 | NIH | None | httpsreporternihgovquickSearchN01CM62203 |
| ID02-148 | None | None | None |
| N01CM17003 | NIH | None | None |
| N01CM62202 | NIH | None | None |
| N01CM17107 | NIH | None | None |