Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06566742
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-20
Brief Title:
A Phase 2 Study Evaluating Olutasidenib in Patients With IDH1-mutated Clonal Cytopenia of Undetermined Significance and Lower-risk MyelodysplasticSyndromesChronic Myelomonocytic Leukemia
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 2 Study Evaluating Olutasidenib in Patients With IDH1-mutated Clonal Cytopenia of Undetermined Significance and Lower-risk MyelodysplasticSyndromesChronic Myelomonocytic Leukemia
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:
None
Brief Summary:
To learn if olutasidenib can help to control CCUS MDS andor CMML The safety of the drug will also be studied
Detailed Description:
Primary Objectives - To determine the response rate of olutasidenib monotherapy in patients with IDH1-mutated CCUS or lower-risk MDSCMML
Secondary Objectives
To evaluate the rates of transfusion independence defined as the absence of transfusions over a period of at least 8 weeks
To ascertain the safety and tolerability of olutasidenib monotherapy in these participants populations
To determine survival and rates of leukemia transformation
To analyze reduction in IDH1 clone size
Exploratory Objectives
- To investigate global gene expression profiles DNA methylation profiles and other potential prognostic markers to explore predictors of antitumor activity andor resistance to treatment
Secondary Objectives
To evaluate the rates of transfusion independence defined as the absence of transfusions over a period of at least 8 weeks
To ascertain the safety and tolerability of olutasidenib monotherapy in these participants populations
To determine survival and rates of leukemia transformation
To analyze reduction in IDH1 clone size
Exploratory Objectives
- 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