Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06629584
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-25
Brief Title:
Phase II Study of Asciminib for Second-line Treatment of Chronic Phase Chronic Myeloid Leukemia
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Phase II Study of Asciminib for Second-line Treatment of Chronic Phase Chronic Myeloid Leukemia
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is an open label phase 2 study investigating asciminib in patients previously treated with one line of TKI therapy
Detailed Description:
Primary Objectives
1 To determine the rate of major molecular response MMR at 12 months
Secondary Objectives
1 To estimate the proportion of patients achieving a complete cytogenetic response CCyR major molecular response MMR and molecular response 4 and MR45 MR45 by 3 6 12 except for MMR as primary endpoint 18 and 24 months
2 To estimate the time to CCyR MMR MR40 and MR45
3 To determine the safety and tolerability profile of asciminib in the second line setting
4 To determine the event-free survival EFS survival free from transformation to accelerated and blast phase TFS and overall survival OS
5 To evaluate the rate of adverse events AEs
Exploratory Objectives
1 To describe patient reported outcomes using the MDASI-CML instrument
2 To evaluate development of resistance mutations and their impact on outcomes
1 To determine the rate of major molecular response MMR at 12 months
Secondary Objectives
1 To estimate the proportion of patients achieving a complete cytogenetic response CCyR major molecular response MMR and molecular response 4 and MR45 MR45 by 3 6 12 except for MMR as primary endpoint 18 and 24 months
2 To estimate the time to CCyR MMR MR40 and MR45
3 To determine the safety and tolerability profile of asciminib in the second line setting
4 To determine the event-free survival EFS survival free from transformation to accelerated and blast phase TFS and overall survival OS
5 To evaluate the rate of adverse events AEs
Exploratory Objectives
1 To describe patient reported outcomes using the MDASI-CML instrument
2 To evaluate development of resistance mutations and their impact on outcomes
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