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OncoMatch/Clinical Trials/NCT06597734

A Phase 2 Study Evaluating Olutasidenib in Combination With Hypomethylating Agents in Patients With IDH1-mutated Higher-risk Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, or Advanced Myeloproliferative Neoplasm

Is NCT06597734 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Olutasidenib for chronic myelomonocytic leukemia.

Phase 2RecruitingM.D. Anderson Cancer CenterNCT06597734Data as of May 2026

Treatment: OlutasidenibTo learn if olutasidenib, when combined with a drug called a hypomethylating agent (HMA) can help to control MDS, CMML, and/or MPN. The safety of the drug combination will also be studied.

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Extracted eligibility criteria

Cancer type

Acute Myeloid Leukemia

Myeloproliferative Neoplasm

Myelodysplastic Syndrome

Biomarker criteria

Required: IDH1 mutation

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Cannot have received: hypomethylating agent

Exception: treatment-naive arm only; prior HMA not allowed

Participants on the treatment-naive arm must not have received a prior HMA

Lab requirements

Kidney function

calculated creatinine clearance >= 50 mL/min (Cockcroft-Gault, MDRD, or CKD-Epi)

Liver function

Bilirubin <= 2x ULN or <= 3x ULN in participants with Gilbert Syndrome; AST, ALT, and alkaline phosphatase <= 3x ULN

Acceptable liver function: Bilirubin <= 2x ULN or <= 3x ULN in participants with Gilbert Syndrome; AST, ALT, and alkaline phosphatase <= 3x ULN. Acceptable renal function: 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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