Ignite Creation Date:
2024-05-06 @ 3:47 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04752527
Status:
UNKNOWN
Last Update Posted:
2021-11-15
First Post:
2021-02-09
Brief Title:
Individualized Induction Therapy for Non-elderly Acute Myeloid Leukemia Patients With Adverse Risk Features
Sponsor:
The First Affiliated Hospital of Soochow University
Organization:
The First Affiliated Hospital of Soochow University
Study Overview
Official Title:
The Clinical Study of Individualized Induction Therapy for Non-elderly Patients With Acute Myeloid Leukemia and Adverse Risk Features Guided by Rapid Screening With FISH and NGS
Status:
UNKNOWN
Status Verified Date:
2021-02
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:
Individualized induction therapy will be applied to the non-elderly acute myeloid leukemia AML patients with adverse genetic risk features guided by rapid screening with fluorescence in situ hybridization FISH and next-generation sequencing NGS such as the combination of Venetoclax plus decitabine and Sorafenib for patients with high FMS-like tyrosine kinase 3-internal tandem duplication FLT3-ITD allelic ratio This study aims to improve induction therapy for non-elderly AML patients with adverse genetic risk features reduce treatment-related complications and improve overall survival
Detailed Description:
The non-elderly AML patients who meet the adverse risk group defined as 2017 European LeukemiaNet ELN risk stratification are more likely to be refractory to intensive induction and have low rates of long-term survival Venetoclax drug name plus decitabine or azacitidine showed tolerable safety and favorable overall response rate ORR complete remission CRCR with incomplete hematologic recovery CRi rate 67 in elderly AML patients In addition combination therapy with sorafenib cytarabine and idarubicin was able to induce a high CR rate in non-elderly AML patients with FLT3 mutations and a 1-year probability of survival of 74 The fast next-generation sequencing together with FISH can identify the adverse genetic risk features in AML patients within 72 hours Individualized induction therapy will be applied to the non-elderly AML patients with adverse genetic risk features guided by rapid screening with FISH and NGS such as the combination of venetoclax plus decitabine and Sorafenib for patients with high FLT3-ITD allelic ratio This study aims to improve induction therapy for non-elderly AML patients with adverse genetic risk features reduce treatment-related complications and improve overall survival
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