Ignite Creation Date:
2024-06-16 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06423911
Status:
RECRUITING
Last Update Posted:
2024-05-21
First Post:
2024-05-16
Brief Title:
Study of Olverembatinib HQP1351 in Patients With CP-CML
Sponsor:
Ascentage Pharma Group Inc
Organization:
Ascentage Pharma Group Inc
Study Overview
Official Title:
This is a Global Multi-center Open-label Randomized and Registrational Phase 3 Study of Olverembatinib HQP1351 in Patients With Chronic Phase Chronic Myeloid Leukemia
Status:
RECRUITING
Status Verified Date:
2024-07
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:
POLARIS-2
Brief Summary:
A Global Multicenter Open Label Randomized Phase 3 Registrational Study of Olverembatinib HQP1351 in Patients with Chronic Phase Chronic Myeloid Leukemia POLARIS-2
Detailed Description:
The hypothesis suggests that in Part A olverembatinib leads to a higher MMR rate compared to bosutinib in CP-CML patients without the T315I mutation and in Part B olverembatinib can provide therapeutic benefits to CP-CML patients with the T315I mutation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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