Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00078234
Status:
COMPLETED
Last Update Posted:
2011-11-06
First Post:
2004-02-20
Brief Title:
Genasense Oblimersen Sodium Fludarabine and Rituximab in Subjects With Chronic Lymphocytic Leukemia
Sponsor:
Genta Incorporated
Organization:
Genta Incorporated
Study Overview
Official Title:
A Pilot Study of Genasense G3139 Oblimersen Sodium Bcl-2 Antisense Oligonucleotide Fludarabine and Rituximab in Previously Treated Subjects With Chronic Lymphocytic Leukemia
Status:
COMPLETED
Status Verified Date:
2009-05
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 treatment combination of Rituxan rituximab and fludarabine has previously been reported to produce a high percentage of responses with less toxicity than other combination treatments However some leukemia subjects continue to have leukemia despite treatment with these standard anticancer drug therapies or they may work for only a short period of time In some subjects when the leukemia does not respond well to therapy the leukemia cells may be over-producing one or more proteins One of these proteins is called Bcl-2 Bcl-2 is a protein that appears to protect cancer cells from being killed and thus lengthens the life of the cancer cells Genasense oblimersen sodium is a compound that blocks production of the Bcl-2 protein By first lowering levels of Bcl-2 it is possible that chemotherapy drugs may work more effectively as a cancer treatment Genasense may also directly kill CLL cells This study will test whether treating subjects with Genasense fludarabine and rituximab is safe and effective
Detailed Description:
None
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