Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06652685
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-15
Brief Title:
Molecular Subtype Combined with Early Minimal Residual Disease to Optimize the Treatment of Newly Diagnosed Acute Myeloid Leukemia
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Molecular Subtype Combined with Early Minimal Residual Disease to Optimize the Treatment of Young Treatment-naive Acute Myeloid Leukemia a Multicenter Phase II Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
None
Brief Summary:
This study aims to investigate the safety and efficacy of drug X in combination with intensive chemotherapy in subjects with newly diagnosed AML excluding APL and CBF-AML X drugs included BCL-2 inhibitor venetoclax and FLT3 inhibitor Gilteritinib
Subjects will receive standard intensive chemotherapy during induction and consolidation Early induction response will be evaluated according to the results of peripheral blood blast clearance rate on the fifth day after induction therapy D5-PBCR Venetoclax will be added in D5-PBCR positive subjects For subjects with FLT3 mutations Gilteritinib will be combined
Subjects will be stratified based on the genetic risk classification of 2022 European LeukemiaNet recommendations ELN risk and MRD status to receive specific consolidation therapy after the induction therapy
Subjects will receive standard intensive chemotherapy during induction and consolidation Early induction response will be evaluated according to the results of peripheral blood blast clearance rate on the fifth day after induction therapy D5-PBCR Venetoclax will be added in D5-PBCR positive subjects For subjects with FLT3 mutations Gilteritinib will be combined
Subjects will be stratified based on the genetic risk classification of 2022 European LeukemiaNet recommendations ELN risk and MRD status to receive specific consolidation therapy after the induction therapy
Detailed Description:
Young patients with naïve AML excluding APL and CBF-AML were included in this study 218 subjects who meet the eligibility criteria will receive the standard 37 intensive chemotherapy induction containing cytarabine and idarubicin On the basis of the IA induction regimen the early chemotherapy response was evaluated according to the results of peripheral blood blast clearance rate on the fifth day after induction therapy D5-PBCR For D5-PBCR-positive patients venetoclax will be added to conventional chemotherapy For patients with FLT3 mutations gilteritinib will be combined
Subjects who achieve a composite complete remission CRc after induction therapy will receive further consolidation therapy which regimen will be decided based on the ELN risk at diagnosis and MRD status detected by MFC and gene quantification after induction therapy
The purpose of the study is to determine whether the addition of drug X to the standard induction regimen improves efficacy in the treatment of naïve AML
Primary objective To evaluate whether intensive IA combined with targeted drug drug X regimens can improve the composite response rate CRc after 1 course of induction therapy in newly diagnosed young AML patients Secondary Objective To evaluate whether intensive chemotherapy combined with drug X during induction and consolidation can improve overall response rates overall survival and event-free survival in newly diagnosed young AML patients Safety indicators incidence of adverse reactions during treatment recovery time of neutrophils and platelets
Subjects who achieve a composite complete remission CRc after induction therapy will receive further consolidation therapy which regimen will be decided based on the ELN risk at diagnosis and MRD status detected by MFC and gene quantification after induction therapy
The purpose of the study is to determine whether the addition of drug X to the standard induction regimen improves efficacy in the treatment of naïve AML
Primary objective To evaluate whether intensive IA combined with targeted drug drug X regimens can improve the composite response rate CRc after 1 course of induction therapy in newly diagnosed young AML patients Secondary Objective To evaluate whether intensive chemotherapy combined with drug X during induction and consolidation can improve overall response rates overall survival and event-free survival in newly diagnosed young AML patients Safety indicators incidence of adverse reactions during treatment recovery time of neutrophils and platelets
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