Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06611839
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-19
Brief Title:
Venetoclax and Ivosidenib Combined with Chemotherapy in IDH1 Mutated AML
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Multicenter Single-arm Clinical Study of Venetoclax and Ivosidenib Combined with Intensive Chemotherapy in the Treatment of Fit Adult Acute Myeloid Leukemia Patients with IDH1 Mutations
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
IDH1-AML-2024
Brief Summary:
Leukemia is one of the common malignant tumors threatening human health Intensive chemotherapy or non-intensive chemotherapy has limited efficacy There is an urgent need to improve treatment outcomes with more specific well-designed drugs that target leukemia specifically
The induction therapy of venetoclax combined with demethylation agents HAM significantly improves the response rate in elderly unfit AML patients more than 60 and studies are being conducted in venetoclax combination with intensive induction 3 7 and consolidation chemotherapy in newly treated AML patients
Isocitrate dehydrogenase IDH 1 and 2 are present in the citric acid cycle About 20 of AML patients carry IDH1 or IDH2 mutations that result in the reduction of alpha-ketoglutaric acid to 2-hydroxyglutaric acid 2-HG which methylates intracellular histones and inhibits TET2 activity to hypermethylate DNA thereby affecting gene expression and cell differentiation IDH mutations are more common in older patients are often cytogenetically-related and can also co-occur with FLT3-ITD NPM1 or DNMT3A mutations Ivosidenib is an IDH1 inhibitor and its safety and efficacy in the treatment of AML have been confirmed in previous studies Based on the study of Montesinos et al on the role of ivosidenib and azacitidine in IDH-mutated AML for patients who cannot tolerate intensive chemotherapy a new treatment regimen has been added for AML patients with IDH1 mutation ivosidenib combined with azacitidine can be selected for 1 cycle every 28 days or ivosidenib monotherapy
Therefore this study intends to conduct a multi-center single-arm clinical study to determine the maximum tolerated dose of ivosidenib and venetoclax combined chemotherapy and the compound complete response rate the negative conversion rate of MRD and IDH1
The induction therapy of venetoclax combined with demethylation agents HAM significantly improves the response rate in elderly unfit AML patients more than 60 and studies are being conducted in venetoclax combination with intensive induction 3 7 and consolidation chemotherapy in newly treated AML patients
Isocitrate dehydrogenase IDH 1 and 2 are present in the citric acid cycle About 20 of AML patients carry IDH1 or IDH2 mutations that result in the reduction of alpha-ketoglutaric acid to 2-hydroxyglutaric acid 2-HG which methylates intracellular histones and inhibits TET2 activity to hypermethylate DNA thereby affecting gene expression and cell differentiation IDH mutations are more common in older patients are often cytogenetically-related and can also co-occur with FLT3-ITD NPM1 or DNMT3A mutations Ivosidenib is an IDH1 inhibitor and its safety and efficacy in the treatment of AML have been confirmed in previous studies Based on the study of Montesinos et al on the role of ivosidenib and azacitidine in IDH-mutated AML for patients who cannot tolerate intensive chemotherapy a new treatment regimen has been added for AML patients with IDH1 mutation ivosidenib combined with azacitidine can be selected for 1 cycle every 28 days or ivosidenib monotherapy
Therefore this study intends to conduct a multi-center single-arm clinical study to determine the maximum tolerated dose of ivosidenib and venetoclax combined chemotherapy and the compound complete response rate the negative conversion rate of MRD and IDH1
Detailed Description:
None
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