OncoMatch/Clinical Trials/NCT05010122
ASTX727, Venetoclax, and Gilteritinib for the Treatment of Newly Diagnosed, Relapsed or Refractory FLT3-Mutated Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome
Is NCT05010122 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Decitabine and Cedazuridine and Gilteritinib for acute myeloid leukemia.
Treatment: Decitabine and Cedazuridine · Gilteritinib · Venetoclax — This phase I/II trial studies the best dose of gilteritinib given together with ASTX727 and venetoclax and the effect of ASTX727, venetoclax, and gilteritinib in treating patients with FLT3-mutated acute myeloid leukemia that is newly diagnosed, has come back (relapsed) or does not respond to treatment (refractory) or high-risk myelodysplastic syndrome. Chemotherapy drugs, such as ASTX727, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Venetoclax may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Gilteritinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving ASTX727, venetoclax, and gilteritinib may help to control the disease.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Myelodysplastic Syndrome
Biomarker criteria
Required: FLT3 ITD
patients with either FLT3-ITD or FLT3 D835 mutations will be eligible
Required: FLT3 D835
patients with either FLT3-ITD or FLT3 D835 mutations will be eligible
Performance status
ECOG 0–3(Limited self-care)
Prior therapy
Cannot have received: any prior therapy for AML
Exception: Prior therapy for antecedent hematologic disorder is allowed including prior hypomethylating agent (HMA) therapy for MDS. Prior hydroxyurea or cytarabine given for purposes of cytoreduction is also allowed. Prior all trans-retinoic acid given for presumed acute promyelocytic leukemia is also allowed.
Phase II cohort A: Patients with prior therapy for AML are not eligible.
Cannot have received: >= 3 prior lines of therapy
Exception: Stem cell transplantation, treatment given only for cytoreductive purposes (e.g. hydroxyurea), and growth factors do not count as lines of therapy for this purpose. Prior therapy with venetoclax and gilteritinib is allowed.
Phase II cohort B: Patients with >= 3 prior lines of therapy are not eligible.
Cannot have received: investigational antileukemic agents or chemotherapy agents
Exception: unless full recovery from side effects has occurred or patient has rapidly progressive disease judged to be life-threatening by the investigator. Prior recent treatment with corticosteroids, hydroxyurea and/or cytarabine (given for cytoreduction) permitted.
Treatment with any investigational antileukemic agents or chemotherapy agents in the last 7 days before study entry
Lab requirements
Kidney function
Creatinine clearance >= 30 mL/min
Liver function
Total serum bilirubin <= 2.5 x ULN, unless due to Gilbert's syndrome, hemolysis or the underlying leukemia approved by the PI; ALT or AST <= 3 x ULN, unless due to the underlying leukemia approved by the PI
Total serum bilirubin <= 2.5 x ULN, unless due to Gilbert's syndrome, hemolysis or the underlying leukemia approved by the PI; ALT or AST <= 3 x ULN, unless due to the underlying leukemia approved by the PI; Creatinine clearance >= 30 mL/min
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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