OncoMatch/Clinical Trials/NCT07130695
Olutasidenib Single Plus Combo Therapy in IDH1mut AML After Induction and Consolidation
Is NCT07130695 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies Olutasidenib Investigational Agent Administration for acute myeloid leukemia.
Treatment: Olutasidenib Investigational Agent Administration — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Biomarker criteria
Required: IDH1 mutation
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: induction and/or consolidation therapy — upfront
Completed induction and/or consolidation intended as per treating physician to reach complete response (CR), complete response with partial hematologic recovery (CRh), or complete response with incomplete hematologic recovery (CRi), or morphologic leukemia free state (MLFS) at time of study enrollment. Patients must be within 90 days of their last cycle of upfront therapy.
Cannot have received: non-intensive upfront therapy including hypomethylating agents (HMA) / Venetoclax based (hypomethylating agents, Venetoclax)
Received non-intensive upfront therapy including hypomethylating agents (HMA) /Venetoclax based
Cannot have received: IDH1 inhibitor
Currently receiving other targeted therapies or AML directed therapies, including but not limited to other IDH1 or IDH2 inhibitors, FMS-like tyrosine kinase 3 (FLT3) inhibitors, B-cell lymphoma 2 (BCL-2) inhibitors, menin inhibitors
Cannot have received: IDH2 inhibitor
Currently receiving other targeted therapies or AML directed therapies, including but not limited to other IDH1 or IDH2 inhibitors, FMS-like tyrosine kinase 3 (FLT3) inhibitors, B-cell lymphoma 2 (BCL-2) inhibitors, menin inhibitors
Cannot have received: FLT3 inhibitor
Currently receiving other targeted therapies or AML directed therapies, including but not limited to other IDH1 or IDH2 inhibitors, FMS-like tyrosine kinase 3 (FLT3) inhibitors, B-cell lymphoma 2 (BCL-2) inhibitors, menin inhibitors
Cannot have received: BCL-2 inhibitor
Currently receiving other targeted therapies or AML directed therapies, including but not limited to other IDH1 or IDH2 inhibitors, FMS-like tyrosine kinase 3 (FLT3) inhibitors, B-cell lymphoma 2 (BCL-2) inhibitors, menin inhibitors
Cannot have received: menin inhibitor
Currently receiving other targeted therapies or AML directed therapies, including but not limited to other IDH1 or IDH2 inhibitors, FMS-like tyrosine kinase 3 (FLT3) inhibitors, B-cell lymphoma 2 (BCL-2) inhibitors, menin inhibitors
Cannot have received: other investigational agents
Other investigational agents in another clinical trial within 4 weeks prior to enrollment
Lab requirements
Kidney function
Calculated creatinine clearance (by Cockroft-Gault) ≥30 mL/min
Liver function
Total bilirubin ≤2 × ULN (≤3 × ULN with Gilbert's syndrome and direct bilirubin ≤2 × ULN); AST/ALT ≤3 × ULN
Cardiac function
QTc (Fredericia) ≤ 450 ms (after corrective action is taken); no history of Torsades de Pointes
Calculated creatinine clearance (by Cockroft-Gault) ≥30 mL/min; Total bilirubin ≤2 × ULN (≤3 × ULN with Gilbert's syndrome and direct bilirubin ≤2 × ULN); Serum aspartate aminotransferase/ alanine aminotransferase (AST/ALT) ≤3 × ULN; Corrected Q-T interval (QTc) (Fredericia calculation) > 450 ms (after corrective action is taken); History of Torsades de Pointes
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Virginia Commonwealth University · Richmond, Virginia
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