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OncoMatch/Clinical Trials/NCT03816319

TAK-243 in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndromes With Increased Blasts

Is NCT03816319 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies UAE Inhibitor TAK-243 for myelodysplastic syndrome with excess blasts.

Phase 1RecruitingNational Cancer Institute (NCI)NCT03816319Data as of May 2026

Treatment: UAE Inhibitor TAK-243This phase I trial studies the side effects and best dose of TAK-243 in treating patients with acute myeloid leukemia or myelodysplastic syndromes with increased blasts that has come back (relapsed) or that is not responding to treatment (refractory). TAK-243 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

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Extracted eligibility criteria

Cancer type

Myelodysplastic Syndrome

Acute Myeloid Leukemia

Performance status

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

Prior therapy

Min 1 prior line

Lab requirements

Kidney function

Serum creatinine < 176 mcmol/L (2 mg/dL) OR Creatinine clearance > 60 mL/min based on the Cockcroft-Gault equation.

Liver function

Serum bilirubin <= 1.5 × institutional upper limit of normal (ULN); AST/ALT <= 3 × institutional ULN; Patients with a known history of Gilbert's syndrome may enroll.

Cardiac function

Documented normal cardiac function (>= 50%) by echocardiogram or multi-gated acquisition (MUGA) scan.

Serum bilirubin <= 1.5 × institutional upper limit of normal (ULN). Patients with a known history of Gilbert's syndrome may enroll. AST/ALT <= 3 × institutional ULN. Serum creatinine < 176 mcmol/L (2 mg/dL) OR Creatinine clearance > 60 mL/min based on the Cockcroft-Gault equation. Documented normal cardiac function (>= 50%) by echocardiogram or multi-gated acquisition (MUGA) scan.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Moffitt Cancer Center · Tampa, Florida
  • Northwestern University · Chicago, Illinois
  • Ohio State University Comprehensive Cancer Center · Columbus, Ohio
  • VCU Massey Comprehensive Cancer Center · Richmond, Virginia

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