Seclidemstat and Azacitidine for the Treatment of Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia
Trial Parameters
Brief Summary
This 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.
Eligibility Criteria
Inclusion Criteria: * Age \>= 18 years as myelodysplastic syndrome (MDS) is a very rare disease in the pediatric setting * Diagnosis of MDS or chronic myelomonocytic leukemia (CMML) according to World Health Organization (WHO) and: * MDS with int-1, int-2, or high risk by International Prognostic Scoring System (IPSS), or CMML-1/CMML-2 , myeloproliferative CMML (white blood cell \[WBC\] \>= 13 x 10\^9/L) or CMML-0 with high-risk molecular features (known mutations in ASXL1, SETBP1, RUNX1, NRAS, TP53 or more than 3 mutations). * No response after 6 cycles of azacitidine, decitabine, guadecitabine, ASTX030 or ASTX727 or relapse or progression after any number of cycles * Serum creatinine =\< 1.5 x upper limit of normal (ULN) OR creatinine clearance \>= 50 ml/min for patients with creatinine levels \> 1.5 x ULN * Adequate hepatic function with total bilirubin \< 2 x ULN (will allow less than 5 x ULN if Gilbert's syndrome at investigator's discretion) * Aspartate aminotransferase (AST) or