Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06368414
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-16
First Post:
2024-04-11
Brief Title:
A Study of Treatment-free Remission in Chronic Phase Chronic Myeloid Leukemia
Sponsor:
Korean Society of Hematology
Organization:
Korean Society of Hematology
Study Overview
Official Title:
A Study of Treatment-free Remission in Chronic Phase Chronic Myeloid Leukemia in Combination With Asciminib and Tyrosine Kinase Inhibitors
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
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:
AsterA
Brief Summary:
To evaluate the efficacy of asciminib adding on tyrosine-kinase inhibitors TKI to achieve treatment-free remission TFR in chronic myeloid leukemia CML patients in chronic phase who failed prior cessation study of TKI
Detailed Description:
We expect that patients who lost MR30 after stopping TKIs thus failed to maintain treatment-free remission can achieve second sustainable MR45 by sustainable MR45 for more than 3 years once regained and prolong MRFS by adding asciminib to TKIs Patients will be restarted on TKIs when they fail sustaining MR30 after cessation because restarting TKIs when loss of MR30 is reasonable in this situation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None