Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00021749
Status:
COMPLETED
Last Update Posted:
2009-11-13
First Post:
2001-08-03
Brief Title:
Phase III Study of Genasense in Patients With Chronic Lymphocytic Leukemia
Sponsor:
Genta Incorporated
Organization:
Genta Incorporated
Study Overview
Official Title:
Phase I-II Multicenter Study of Genasense Bcl-2 Antisense Oligonucleotide in Patients With Advanced Chronic Lymphocytic Leukemia
Status:
COMPLETED
Status Verified Date:
2009-11
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:
This non-randomized study will test the safety and effectiveness of Genasense in patients with CLL
Detailed Description:
This study is a two-part phase I-II study Part 1 will determine the MTD of Genasense in patients with CLL This dose will then be tested in a non-randomized multi-center Phase II sequential clinical trial of Genasense used alone for treatment of patients with advanced CLL
Pharmacokinetics of Genasense and kinetics of Bcl-2 down regulation and re-expression in CLL cells will be followed in selected patients
Pharmacokinetics of Genasense and kinetics of Bcl-2 down regulation and re-expression in CLL cells will be followed in selected patients
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 |
|---|---|---|---|
| G3139 | None | None | None |
| Bcl-2 Antisense | None | None | None |