Ignite Creation Date:
2024-05-06 @ 1:09 PM
Last Modification Date:
2024-10-26 @ 1:09 PM
Study NCT ID:
NCT03942094
Status:
UNKNOWN
Last Update Posted:
2022-03-16
First Post:
2019-05-06
Brief Title:
Nilotinib for First-line Newly Diagnosed CML-CP Patients
Sponsor:
Shenzhen Second Peoples Hospital
Organization:
Shenzhen Second Peoples Hospital
Study Overview
Official Title:
Efficacy and Safety of Nilotinib as the First-line Treatment for Patients With Newly Diagnosed Chronic-phase Chronic Myeloid Leukemia a Prospective Study
Status:
UNKNOWN
Status Verified Date:
2022-03
Last Known Status:
RECRUITING
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:
This is a phase IIIb multi-centre single-arm open-label prospective study investigating the efficacy and safety of nilotinib as the first-line treatment for the adult patients with newly diagnosed chronic-phase chronic myeloid leukemia CML-CP in China Nilotinib 300 mg BID will be provided in this study The assessment for the primary efficacy endpoint will be performed at 18 months and the rate of patients obtaining MR45 will be measured at this time point Secondary endpoints include the complete hematologic responseCHR and the rates of major molecular reactions MMR by 3 6 91218 and 24 months event free survival EFS overall survival OS
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