OncoMatch/Clinical Trials/NCT04774393
Decitabine/Cedazuridine and Venetoclax in Combination With Ivosidenib or Enasidenib for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia
Is NCT04774393 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Decitabine and Cedazuridine and Enasidenib for acute myeloid leukemia.
Treatment: Decitabine and Cedazuridine · Enasidenib · Ivosidenib · Venetoclax — This phase Ib/II trials studies the side effects of decitabine/cedazuridine (ASTX727) and venetoclax in combination with ivosidenib or enasidenib, and how well they work in treating patients with acute myeloid leukemia that has come back (relapsed) or does not respond to treatment (refractory). ASTX727 is the combination of a fixed dose of 2 drugs, cedazuridine and decitabine. Cedazuridine may slow down how fast decitabine is broken down by the body, and decitabine may block abnormal cells or cancer cells from growing. Venetoclax may stop the growth of cancer cells by blocking BCL-2, a protein needed for cancer cell survival. Enasidenib and ivosidenib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving decitabine/cedazuridine and venetoclax in combination with ivosidenib or enasidenib may help control acute myeloid leukemia.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Biomarker criteria
Required: IDH1 any mutation
Subjects must have documented IDH1 or IDH2 gene mutation
Required: IDH2 any mutation
Subjects must have documented IDH1 or IDH2 gene mutation
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Lab requirements
Kidney function
Creatinine clearance ≥30 mL/min to <45 mL/min; Adequate renal function including creatinine < 2 unless related to the disease
Liver function
Moderate hepatic impairment with total bilirubin >1.5 to ≤3.0 × ULN; Direct bilirubin < 2 x ULN unless increase is due to Gilbert's disease or leukemic involvement; AST and/or ALT < 3 x ULN unless considered due to leukemic involvement, in which case direct bilirubin or AST and/or ALT < 5 x ULN will be considered eligible
Cardiac function
Severe cardiac disorder (eg, congestive heart failure requiring treatment, ejection fraction ≤50%, or chronic stable angina) defines ineligibility for intensive chemotherapy
Severe cardiac disorder (eg, congestive heart failure requiring treatment, ejection fraction ≤50%, or chronic stable angina). Severe pulmonary disorder (eg, DLCO ≤65% or forced expiratory volume in 1 second [FEV1] ≤65%). Creatinine clearance ≥30 mL/min to <45 mL/min. Moderate hepatic impairment with total bilirubin >1.5 to ≤3.0 × ULN. Adequate renal function including creatinine < 2 unless related to the disease. Direct bilirubin < 2 x upper limit of normal (ULN) unless increase is due to Gilbert's disease or leukemic involvement. AST and/or ALT < 3 x ULN unless considered due to leukemic involvement, in which case direct bilirubin or AST and/or ALT < 5 x ULN will be considered eligible
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- M D Anderson Cancer Center · Houston, Texas
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify