OncoMatch/Clinical Trials/NCT05184842
Metabolically Optimized, Non-cytotoxic Low Dose Weekly Decitabine/Venetoclax in MDS and AML
Is NCT05184842 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Venetoclax and Decitabine for myelodysplastic syndromes.
Treatment: Venetoclax · Decitabine — Myeloid malignancies which include AML (acute myeloid leukemia) and MDS (myelodysplatic syndrome) are cancers of the bone marrow which lead to bone marrow failure. The bone marrow is the place or factory in the body where components of blood such as red cells, platelets and white cells are made. In bone marrow failure, the ability of the bone marrow to make these cells is decreased. The decreased bone marrow function is the result from abnormalities that develop in the malignant cells which prevent the normal maturation process by which bone marrow cells develop into red blood cells, white blood cells and platelets. The malignant cells in the bone marrow are not good at maturing to make the components of the blood that you need, they occupy space in the bone marrow and prevent the function of remaining normal bone marrow cells. DNA is a chemical substance within cells that stores information needed for cell growth and cell behavior. One approach to treating the malignant 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. Decitabine is FDA approved for treatment of MDS and AML. Venetoclax is approved for AML in combination with Azacitidine for patients with AML or are over age 75 or unfit for chemotherapy. In this study, Decitabine and venetoclax will be administered using a low dose weekly schedule in an attempt to improve efficacy by decreasing the side effects often seen when these drugs are given at standard dosing.
Check if I qualifyExtracted eligibility criteria
Cancer type
Myelodysplastic Syndrome
Acute Myeloid Leukemia
Prior therapy
Must have received: hypomethylating agent
Indication for therapy with potential sensitivity to hypomethylating agents (HMA) therapy, defined as prior published evidence of response to HMA
Cannot have received: hypomethylating agent (azacitidine, decitabine)
Prior Treatment with azacitidine, decitabine
Cannot have received: BCL2 inhibitor (venetoclax)
Prior Treatment with...venetoclax
Cannot have received: disease directed therapy (other than hydroxyurea)
Exception: hydroxyurea allowed
No other disease directed therapy, save for hydroxyurea, including experimental or investigational drug therapy for 14 days prior to study entry
Lab requirements
Kidney function
creatinine clearance ≥30 mL/min or on dialysis is allowed
Liver function
AST and ALT < 4× ULN; Bilirubin ≤ 2× ULN (direct bilirubin ≤ 1.5× ULN if elevated due to impaired conjugation or hemolysis)
adequate end organ function defined as. Aspartate aminotransferase (AST) and Alanine transaminase (ALT) < 4× the upper limit of normal (ULN); Bilirubin ≤ 2× the ULN (upper limit of normal). 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× the ULN; renal function with a creatinine clearance ≥30 mL/min or on dialysis is allowed
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of California Davis Health (UC Davis Health) · Sacramento, California
- Montefiore Medical Center · The Bronx, New York
- White Plains Hospital · White Plains, New York
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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