Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06453902
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-12
First Post:
2024-05-28
Brief Title:
TGRX-678 Chinese Phase II in Chronic Myelogenous Leukemia CML Patients
Sponsor:
Shenzhen TargetRx Inc
Organization:
Shenzhen TargetRx Inc
Study Overview
Official Title:
A Single-arm Open-label Multi-center Phase II Study Evaluating Efficacy and Safety of TGRX-678 in CML-AP Patients Relapsed or Refractory From 3rd-generation TKI Treatment
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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:
A Phase II study evaluating the safety and efficacy of TGRX-678 in Chronic Myelogenous Leukemia CML patients in Accelerated phase AP and are relapsed or refractory from third-generation Tyrosine Kinase Inhibitor TKI treatment
Detailed Description:
This Phase II study is of single-arm open-label and multi-center designs to study safety and efficacy profiles of TGRX-678 in CML-AP patients Patients need to have medical history of failing treatments from third-generation TKI drugs Patients with or without T315I mutation is enrolled
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?:
False
Is an FDA AA801 Violation?:
None