Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06597734
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-12
Brief Title:
A Phase 2 Study Evaluating Olutasidenib in Combination with Hypomethylating Agents in Patients with IDH1-mutated Higher-risk Myelodysplastic Syndromes Chronic Myelomonocytic Leukemia or Advanced Myeloproliferative Neoplasm
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 2 Study Evaluating Olutasidenib in Combination with Hypomethylating Agents in Patients with IDH1-mutated Higher-risk Myelodysplastic Syndromes Chronic Myelomonocytic Leukemia or Advanced Myeloproliferative Neoplasm
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:
To learn if olutasidenib when combined with a drug called a hypomethylating agent HMA can help to control MDS CMML andor MPN The safety of the drug combination will also be studied
Detailed Description:
Primary Objectives To determine the overall response rate of olutasidenib in combination with investigators choice of HMA in patients with IDH1-mutated higher-risk MDSCMML or advanced MPN Secondary Objectives
The secondary objectives of this study are
To evaluate the rates of complete remission CR and median duration of CR
To ascertain the safety and tolerability of olutasidenib with HMA in this participant population
To determine survival including overall survival OS progression-free survival PFS and duration of response DOR To analyze reduction in IDH1 clone size Exploratory Objectives
To examine overall response rate of patients previously exposed to venetoclax
To investigate global gene expression profiles DNA methylation profiles and other potential prognostic markers to explore predictors of antitumor activity andor resistance to treatment
The secondary objectives of this study are
To evaluate the rates of complete remission CR and median duration of CR
To ascertain the safety and tolerability of olutasidenib with HMA in this participant population
To determine survival including overall survival OS progression-free survival PFS and duration of response DOR To analyze reduction in IDH1 clone size Exploratory Objectives
To examine overall response rate of patients previously exposed to venetoclax
To investigate global gene expression profiles DNA methylation profiles and other potential prognostic markers to explore predictors of antitumor activity andor resistance to treatment
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