OncoMatch/Clinical Trials/NCT04187703
5-Azacitidine and Decitabine Epigenetic Therapy for Myeloid Malignancies
Is NCT04187703 recruiting? Yes, currently enrolling (May 2026). This Early Phase 1 trial studies multiple treatments including 5-azacytidine and Decitabine for myelodysplastic syndromes.
Treatment: 5-azacytidine · Decitabine — Another term for myelodysplastic syndrome is bone marrow failure. The bone marrow is where components of blood such as red cells, platelets and white cells are made. In bone marrow failure, the ability for bone marrow to make these cells is decreased. In myelodysplastic syndrome, this decreased bone marrow function is believed to result from abnormalities that prevent the normal maturation process by which bone marrow cells develop into red blood cells, white blood cells and platelets. In myelodysplastic syndrome, these abnormal bone marrow cells occupy space in the bone marrow and prevent the function of remaining normal bone marrow cells. One approach to treating the abnormal growth of immature cells is to give chemotherapy which damages DNA within these cells and causes their death. Unfortunately, such therapy has side-effects, since even normal cells can be affected by the treatment. Both 5-azacitidine (5AZA) and decitabine (DEC) are FDA-approved to treat MDS. In this study, 5AZA and DEC will be administered using an alternating low doses schedule in an attempt to overcome the known mechanisms of resistance to the administration of 5AZA or DEC as single agents caused by automatic adaptive shifts in DNA metabolism.
Check if I qualifyExtracted eligibility criteria
Cancer type
Myelodysplastic Syndrome
Prior therapy
Must have received: lenalidomide (lenalidomide) — lower risk MDS, if indicated
Participants with lower risk MDS must have failed or have contraindications to available therapies (e.g. lenalidomide, epoetin if indicated for symptomatic anemia and/or transfusion dependence of red cells)
Must have received: erythropoiesis-stimulating agent (epoetin) — lower risk MDS, if indicated
Participants with lower risk MDS must have failed or have contraindications to available therapies (e.g. lenalidomide, epoetin if indicated for symptomatic anemia and/or transfusion dependence of red cells)
Cannot have received: hypomethylating agent (azacitidine, decitabine, guadecitibine)
Prior Treatment with azacitidine, decitabine or investigational HMA therapy with overlapping mechanism of action (e.g. guadecitibine)
Lab requirements
Liver function
AST and ALT < 3× ULN; Bilirubin ≤ 1.5× ULN (direct bilirubin ≤ 1.5× ULN if elevated due to impaired conjugation or hemolysis)
Must have adequate end organ function defined as: AST and ALT < 3× ULN; Bilirubin ≤ 1.5× ULN. If elevated bilirubin is due to impaired conjugation (e.g Gilbert's disease or concomitant medication) or disease related hemolysis, then direct bilirubin ≤ 1.5× ULN. As azacitidine and decitabine have little renal metabolism, and have proven safety even in dialysis participants, renal function is not an inclusion or exclusion criteria
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Cleveland Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center · Cleveland, Ohio
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