Ignite Creation Date:
2025-12-17 @ 2:50 PM
Ignite Modification Date:
2025-12-23 @ 9:56 PM
Study NCT ID:
NCT07130695
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-18
First Post:
2025-08-07
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Olutasidenib Single Plus Combo Therapy in IDH1mut AML After Induction and Consolidation
Sponsor:
Virginia Commonwealth University
Organization:
Study Overview
Official Title:
Olutasidenib Single Agent as Maintenance Therapy in IDH1mut AML After Induction and Consolidation
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Treatment with olutasidenib for isocitrate dehydrogenase 1 (IDH1) mutant acute myeloid leukemia (AML) after completion of traditional intensive induction/consolidation is likely to be safe, tolerable, and may provide clinical benefit in terms of maintenance of remission and perhaps improvement in survival.
Detailed Description:
Up to 15 participants will receive treatment with olutasidenib 150 mg by mouth twice daily for up to 2 years. Participants will be regularly monitored for toxicities, adverse events, quality of life (QOL), and disease status. Once off treatment, participants will continue to be followed for a maximum of 2 years from date of enrollment for survival endpoints
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: