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OncoMatch/Clinical Trials/NCT04734990

Seclidemstat and Azacitidine for the Treatment of Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia

Is NCT04734990 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Azacitidine and Seclidemstat for chronic myelomonocytic leukemia-0.

Phase 1/2RecruitingM.D. Anderson Cancer CenterNCT04734990Data as of May 2026

Treatment: Azacitidine · SeclidemstatThis phase I/II trial identifies the best dose of seclidemstat when given together with azacitidine in treating patients with myelodysplastic syndrome or chronic myelomonocytic leukemia. Seclidemstat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Azacitidine may help block the formation of growths that may become cancer. Giving seclidemstat and azacytidine may kill more cancer cells.

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Extracted eligibility criteria

Cancer type

Acute Myeloid Leukemia

Myelodysplastic Syndrome

Biomarker criteria

Required: ASXL1 mutation

Required: NRAS mutation

Required: RUNX1 mutation

Required: SETBP1 mutation

Required: TP53 mutation

Performance status

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

Prior therapy

Min 1 prior line

Must have received: hypomethylating agent (azacitidine, decitabine, guadecitabine, ASTX030, ASTX727)

No response after 6 cycles of azacitidine, decitabine, guadecitabine, ASTX030 or ASTX727 or relapse or progression after any number of cycles

Lab requirements

Kidney function

serum creatinine <= 1.5 x ULN OR creatinine clearance >= 50 ml/min for patients with creatinine > 1.5 x ULN

Liver function

total bilirubin < 2 x ULN (will allow < 5 x ULN if Gilbert's syndrome at investigator's discretion); AST or ALT <= 3 x ULN

Cardiac function

NYHA class III or IV congestive heart failure or LVEF < 50% by echocardiogram or MUGA scan excluded; history of MI within 6 months or unstable/uncontrolled angina or severe/uncontrolled ventricular arrhythmias excluded; QTcF >= 450 msecs and long QT syndrome or family history of idiopathic sudden death or congenital long QT syndrome excluded

Serum creatinine <= 1.5 x ULN OR creatinine clearance >= 50 ml/min... Adequate hepatic function with total bilirubin < 2 x ULN (will allow < 5 x ULN if Gilbert's syndrome at investigator's discretion)... AST or ALT <= 3 x ULN... NYHA class III or IV congestive heart failure or LVEF < 50% by echocardiogram or MUGA scan excluded; history of MI within 6 months or unstable/uncontrolled angina or severe/uncontrolled ventricular arrhythmias excluded; QTcF >= 450 msecs and long QT syndrome or family history of idiopathic sudden death or congenital long QT syndrome excluded

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

US trial sites

  • M D Anderson Cancer Center · Houston, Texas

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