Ignite Creation Date:
2024-05-05 @ 7:54 PM
Last Modification Date:
2024-10-26 @ 9:55 AM
Study NCT ID:
NCT00760877
Status:
COMPLETED
Last Update Posted:
2016-11-08
First Post:
2008-09-25
Brief Title:
Nilotinib Versus Standard Imatinib 400600 mg Every Day QD Comparing the Kinetics of Complete Molecular Response for Chronic Myelogenous Leukemia in Chronic Phase CML-CP Pts With Evidence of Persistent Leukemia by Real-time Quantitative Polymerase Chain Reaction RQ-PCR
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
An Open Label Randomized Study of Nilotinib vs Standard Imatinib 400600 mg QD Comparing the Kinetics of Complete Molecular Response for CML-CP Patients With Evidence of Persistent Leukemia by RQ-PCR
Status:
COMPLETED
Status Verified Date:
2016-10
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 primary goal of this study was to determine the rate of confirmed best cumulative complete molecular response CMR within the first year of study therapy with imatinib or nilotinib The study also explored the impact and significance of the achieved CMR on patient outcomes progression free survival PFS event free survival EFS and overall survival OS characterized the kinetics of CMR achieved in both treatment arms and after the cross-over
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2009-012616-40 | EUDRACT_NUMBER | None | None |