OncoMatch/Clinical Trials/NCT07304011
Olutasidenib With Azacitidine Followed by Olutasidenib Maintenance for the Treatment of IDH1-mutated Acute Myeloid Leukemia in Patients With Prior Treatment With Venetoclax Plus a Hypomethylating Agent
Is NCT07304011 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Azacitidine and Olutasidenib for acute myeloid leukemia.
Treatment: Azacitidine · Olutasidenib — This phase II trial studies how well giving olutasidenib with azacitidine, followed by olutasidenib maintenance, works in treating patients with IDH1-mutated acute myeloid leukemia (AML) who have received prior treatment with venetoclax plus a hypomethylating agent (HMA-Ven). Olutasidenib and azacitidine may inhibit the growth of cancer cells by blocking certain enzymes required for cell growth. Maintenance therapy can help prevent or delay cancer from coming back. Olutasidenib with azacitidine followed by olutasidenib maintenance may be effective in treating patients with IDH1-mutated AML who have received prior HMA-Ven.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Biomarker criteria
Required: IDH1 r132 mutation (≥ 0.01%)
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: hypomethylating agent plus venetoclax (venetoclax) — first-line
Achieved complete response (CR)/complete remission with incomplete count recovery (CRi) response to first line HMA-Ven according to the European Leukemia Net (ELN) recommendations for diagnosis as determined by investigator review
Cannot have received: IDH1 inhibitor
Prior IDH1 inhibitor (IDH1i) targeted therapy
Cannot have received: AML therapy except for HMA-Ven
Prior AML therapy except for HMA-Ven
Lab requirements
Kidney function
Creatinine clearance ≥ 40 mL/min (calculated by the Cockcroft-Gault formula or measured by 24-hour urine collection)
Liver function
ALT ≤ 3 × ULN; AST ≤ 3 × ULN; Bilirubin ≤ 2 x ULN unless due to Gilbert's syndrome or controlled autoimmune hemolytic anemia (not requiring immunosuppressive other than ≤ 20 mg of prednisolone daily); Patients with Gilbert's syndrome may be included if total bilirubin is ≤ 3 × ULN and direct bilirubin is ≤ 2 × ULN
Cardiac function
Prothrombin time (PT) or INR/aPTT ≤ 1.5 × ULN; QTcF ≤ 480 msec (does not apply to patients with bundle branch block)
Creatinine clearance ≥ 40 mL/min; ALT ≤ 3 × ULN; AST ≤ 3 × ULN; Bilirubin ≤ 2 x ULN unless due to Gilbert's syndrome or controlled autoimmune hemolytic anemia; PT or INR/aPTT ≤ 1.5 × ULN; QTcF ≤ 480 msec
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of California Davis Comprehensive Cancer Center · Sacramento, California
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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