Ignite Creation Date:
2024-05-06 @ 1:47 PM
Last Modification Date:
2024-10-26 @ 1:20 PM
Study NCT ID:
NCT04126681
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-04-04
First Post:
2019-10-11
Brief Title:
A Pivotal Study of HQP1351 in Patients With Chronic Myeloid Leukemia in Chronic Phase
Sponsor:
Ascentage Pharma Group Inc
Organization:
Ascentage Pharma Group Inc
Study Overview
Official Title:
A Phase 2 Randomized Open Label Pivotal Study to Evaluate the Efficacy and Safety of HQP1351 in CML CP Patients Who Are Resistant andor Intolerant to First- and Second-Generation Tyrosine Kinase Inhibitors
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-04
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:
None
Brief Summary:
The purpose of this study is to evaluate the efficacy of HQP1351 in patients with chronic myeloid leukemia in chronic phase CML-CP who are resistant andor intolerant to first- and second-generation tyrosine kinase inhibitors The efficacy of HQP1351 is determined by evaluating the subjects event free survival EFS
Detailed Description:
This is a phase 2 randomized open label pivotal study to evaluate the efficacy and safety of HQP1351 in CML CP patients who are resistant andor intolerant to first- and second-generation TKIs in China A total of 141 CML CP patients will be included in this study After screening eligible subjects will be randomized by 21 ratio to enter HQP1351 therapy cohort and best available therapy BAT cohort When the subjects in the two cohorts reach EFS assessment they can crossover to contralateral cohort if the investigator and Sponsor think they could be clinically benefited During treatment each subject will be assessed regularly for hematological cytogenetic and molecular responses At the same time safety information also will be evaluated
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