Ignite Creation Date:
2024-05-06 @ 5:50 PM
Last Modification Date:
2024-10-26 @ 2:36 PM
Study NCT ID:
NCT05440747
Status:
NOT_YET_RECRUITING
Last Update Posted:
2022-07-01
First Post:
2022-04-02
Brief Title:
Treatment Free Remission TFR in CML Patients CML-CPStudy
Sponsor:
Guangdong Provincial Peoples Hospital
Organization:
Guangdong Provincial Peoples Hospital
Study Overview
Official Title:
A Multicenter Observational Register Study of Treatment Free Remission in Patients With Chronic Myeloid Leukemia CML-CP
Status:
NOT_YET_RECRUITING
Status Verified Date:
2022-06
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:
Improving the quality of life and achieving Treatment-Free RemissionTFR is a long-term goal of treatment in CML-CP patients and deep molecular response DMR is necessary to achieve TFR Cording to the historical literature it is reported that patients with CML-CP take MMR as the therapeutic target and the acquisition rate of DMR under long-term TKI treatment is 50 The 2-year success rate of TFR patients was 50 Therefore maybe only 25 of patients with CML can successfully stop the drug for a long time It cannot meet the withdrawal needs of patients with long-term drug survival
This study is to design a real-world observational registration study for optimal effect On the premise of taking DMR as the target decision through initial treatment intervention improve the DMR rate which will promote clinical practice so as to improve the 2-year TFR rate of cml-cp patients This study is a multicenter observational prospective registry to identify the optimal treatment for achieving TFR in CML patients In this study the investigators will assess the deep molecular response after 12 months of treatment and the 2-year treatment-free remission rate TFR 2y after drug discontinuation
Eligible participants with CML-CP can be enrolled The observation period of all participants is at least 60 months of which the first 36 months is the shortest treatment period and the last 24 months is the TFR observation period after TKIs ImatinibFlumatinibNilotinb Dasatinib withdrawal During the treatment phase participants can receive TKIs IFN or other treatments as first-linesecond-line treatment and the treatment plan will be adjusted according to the molecular response Patients should accept TKI treatment for at least 3 years or more and MR4MR45 should achieve at least 2 years before discontinuation
This study is to design a real-world observational registration study for optimal effect On the premise of taking DMR as the target decision through initial treatment intervention improve the DMR rate which will promote clinical practice so as to improve the 2-year TFR rate of cml-cp patients This study is a multicenter observational prospective registry to identify the optimal treatment for achieving TFR in CML patients In this study the investigators will assess the deep molecular response after 12 months of treatment and the 2-year treatment-free remission rate TFR 2y after drug discontinuation
Eligible participants with CML-CP can be enrolled The observation period of all participants is at least 60 months of which the first 36 months is the shortest treatment period and the last 24 months is the TFR observation period after TKIs ImatinibFlumatinibNilotinb Dasatinib withdrawal During the treatment phase participants can receive TKIs IFN or other treatments as first-linesecond-line treatment and the treatment plan will be adjusted according to the molecular response Patients should accept TKI treatment for at least 3 years or more and MR4MR45 should achieve at least 2 years before discontinuation
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