Ignite Creation Date:
2024-05-05 @ 4:38 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00285103
Status:
COMPLETED
Last Update Posted:
2011-02-02
First Post:
2005-09-12
Brief Title:
SPC2996 in Chronic Lymphocytic Leukaemia
Sponsor:
Santaris Pharma AS
Organization:
Santaris Pharma AS
Study Overview
Official Title:
An Open-labelled International Multicenter Dose Escalating Phase III Study of SPC2996an LNA Antisense Molecule Against Bcl-2 in Patients With Relapsed or Refractory Chronic Lymphocytic Leukaemia
Status:
COMPLETED
Status Verified Date:
2011-02
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 purpose of this study is to determine whether SPC2996 is effective and safe in the treatment of Chronic Lymphocytic Leukaemia CLL
Detailed Description:
Chronic Lymphocytic Leukaemia CLL is the most common leukaemia in adults in the US and most of Western Europe Many patients suffering from CLL have tumour cells expressing high amounts of Bcl-2 protein Since over expression of Bcl-2 inhibits apoptosis it is possible that this gene participates in the pathogenesis of CLL By lowering the Bcl-2 protein in these tumour cells the cells may go into apoptosis due to changed balance in pro- and anti apoptotic proteins and thereby it might be possible to induce a tumour response
The study is an open-labelled international multicenter dose escalating phase III study where patients receive 6 3 2 or 1 doses of SPC2996 a LNA antisense molecule against Bcl-2 over a period of up to 2 weeks and are followed for 6 months
The study is an open-labelled international multicenter dose escalating phase III study where patients receive 6 3 2 or 1 doses of SPC2996 a LNA antisense molecule against Bcl-2 over a period of up to 2 weeks and are followed for 6 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