Ignite Creation Date:
2024-05-06 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04739826
Status:
RECRUITING
Last Update Posted:
2023-11-03
First Post:
2021-02-01
Brief Title:
Flumatinib Versus Nilotinib for Newly Diagnosed Chronic Phase Chronic Myeloid Leukemia
Sponsor:
The First Affiliated Hospital of Soochow University
Organization:
The First Affiliated Hospital of Soochow University
Study Overview
Official Title:
Evaluating Efficacy and Safety of Flumatinib Versus Nilotinib for Newly Diagnosed Chronic Phase Chronic Myeloid LeukemiaCML-CP A Multicenter Open-lable Real World Study
Status:
RECRUITING
Status Verified Date:
2023-07
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:
None
Brief Summary:
The ultimate goal of CML treatment is to improve survival including overall survival OS progression-free survival PFS event-free survival EFS and treatment-free remission TFR TFR is a new therapeutic goal for chronic myeloid leukemia in chronic phase CML-CP In ENESTnd and DASISION trials both nilotinib and dasatinib achieved DMR more effectively than imatinib In the guidelines for diagnosis and treatment of chronic myeloid leukemia in China 2020 edition flumatinib has been recommended as an appropriate first-line treatment for newly diagnosed chronic phase chronic myeloid leukemia CML-CP patients There is no doubt that the second-generation TKIs show great advantages in deep molecular response which further increases the possibility of achieving treatment-free remission However there is no direct comparative study to determine which TKI is better for de novo CML-CP Thus we conducted a multi-center open-lable and real world study to compare the efficacy and safety between flumatinib and nilotinib
Detailed Description:
None
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