OncoMatch/Clinical Trials/NCT06566742
A Phase 2 Study Evaluating Olutasidenib in Patients With IDH1-mutated Clonal Cytopenia of Undetermined Significance and Lower-risk Myelodysplastic/Syndromes/Chronic Myelomonocytic Leukemia.
Is NCT06566742 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Olutasidenib for myelodysplastic syndromes.
Treatment: Olutasidenib — To learn if olutasidenib can help to control CCUS, MDS, and/or CMML. The safety of the drug will also be studied.
Check if I qualifyExtracted eligibility criteria
Cancer type
Myelodysplastic Syndrome
Acute Myeloid Leukemia
Biomarker criteria
Required: IDH1 mutation (variant allele frequency (VAF) ≥ 0.02)
documented IDH1 mutation with variant allele frequency (VAF) ≥ 0.02
Disease stage
Required: Stage IPSS LOW-RISK, IPSS INTERMEDIATE-1-RISK, IPSS-R ≤ 3.5, IPSS-M VERY LOW-RISK, IPSS-M LOW-RISK, IPSS-M MODERATE LOW-RISK (IPSS, IPSS-R, IPSS-M)
Lower-risk MDS/CMML includes patients with International Prognostic Scoring System (IPSS) low- or intermediate-1-risk disease and Revised IPSS (IPSS-R) score ≤ 3.5 and Molecular IPSS (IPSS-M) very low-, low-, or moderate low-risk categories.
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Lab requirements
Kidney function
serum creatinine ≤ 1.5 times ULN or calculated creatinine clearance ≥ 50 mL/min (as assessed by Cockcroft-Gault, MDRD, or CKD-Epi validated measures)
Liver function
Bilirubin ≤ 2 times upper limit of normal (ULN) or ≤ 3 times ULN in patients with Gilbert Syndrome. AST, ALT, and alkaline phosphatase ≤ 3 times ULN.
Bilirubin ≤ 2 times upper limit of normal (ULN) or ≤ 3 times ULN in patients with Gilbert Syndrome. AST, ALT, and alkaline phosphatase ≤ 3 times ULN. Acceptable renal function with serum creatinine ≤ 1.5 times ULN or calculated creatinine clearance ≥ 50 mL/min (as assessed by Cockcroft-Gault, MDRD, or CKD-Epi validated measures).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- MD Anderson Cancer Center · Houston, Texas
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