Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06561880
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-08
Brief Title:
The Efficacy of Triple Regimen in Newly Diagnosed AML Patients With FLT3 Mutation
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Multi-center Single-arm Trial of the Efficacy of a Triple Regimen Including Gilteritinib Venetoclax and Azacitidine in Newly Diagnosed Fit AML Patients With FLT3 Mutation
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FLT3AML-2024
Brief Summary:
The FMS tyrosine kinase 3 FLT3 gene mutation occurs in 30 of newly diagnosed AML patients leading to a higher relapse rate and mortality rate In the past multi-drug combination chemotherapy regimens had limited efficacy in newly diagnosed AML patients with FLT3 mutations especially in those with FLT3-ITD However the FLT3 inhibitors greatly improved the survival of AML patients with FLT3 mutations Although several studies have focused on the effectiveness of FLT3 inhibitor combination therapy for FLT3-mutated AML further studies are needed to determine the optimal regimen and dosage A triple regimen consisting of Gilteritinib Venetoclax and Azacitidine had shown good efficacy in unfit newly diagnosed FLT3-mutated AML patients This clinical trial aims to determine the optimal dosage of the triple regimen and investigate its efficacy in newly diagnosed fit FLT3-mutated AML patients Besides this trial will provide evidence for treatment decisions based on measurable residual disease in patients with the triple regimen
Detailed Description:
This stuay intends to conduct a multi-center single-arm clinical study to explore the efficacy of the triple induction regimen consisting of Gilteritinib Venetoclax and Azacitidine in newly diagnosed FLT3 mutated AML patients who are suitable for intensive chemotherapy The maximum dose of Gilteritinib that can be safely combined with Azacitidine and Venetoclax will be determined Patients will receive 2 courses of a triple regimen therapy for induction and those who achieved complete remission will receive 3 courses of intermediate-dose cytarabine for consolidation After consolidation therapy dose-adjusted triple regimen therapy will be applied for 6 courses as maintenance treatment Bone marrow morphology and minimal residual disease detected by flow cytometry and next-generation sequencing will be monitored during the treatment to provide evidence for treatment decisions Response and survival of patients will be recorded to evaluate the efficacy of the triple regimen
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None