OncoMatch/Clinical Trials/NCT07283094
FHD-286 With Low-Dose Weekly Decitabine/Venetoclax in Patients With Acute Myeloid Leukemia
Is NCT07283094 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Decitabine and Venetoclax for acute myeloid leukemia.
Treatment: Decitabine · Venetoclax · FHD-286 — This is a Phase 1, uncontrolled, single-arm, open-label, nonrandomized, dose escalation, study of Decitabine (DAC)+Venetoclax (VEN)+FHD-286 in participants with newly diagnosed Acute Myeloid Leukemia (AML) classified as adverse risk per the 2022 European Leukemia Net (ELN) criteria or AML that has progressed after one prior line of therapy.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Myelodysplastic Syndrome
Performance status
ECOG 0–3(Limited self-care)
ECOG PS: New diagnosed AML: 75 years: ≤2; 18 years to <75 years: ≤3; AML that has progressed after 1 prior line of therapy (Any age): 3 if R/R AML
Prior therapy
Cannot have received: hypomethylating agent (azacitidine, decitabine)
Exception: For individuals with AML that has progressed after 1 prior line of therapy, prior treatment with Azacitidine, Decitabine and VEN is allowed
Have not received a hypomethylating agent (HMA) or VEN for their disease under study; Prior treatment with azacitidine, DAC, VEN, or FHD-286. For individuals with AML that has progressed after 1 prior line of therapy, prior treatment with Azacitidine, Decitabine and VEN is allowed
Cannot have received: BCL2 inhibitor (venetoclax)
Exception: For individuals with AML that has progressed after 1 prior line of therapy, prior treatment with Azacitidine, Decitabine and VEN is allowed
Have not received a hypomethylating agent (HMA) or VEN for their disease under study; Prior treatment with azacitidine, DAC, VEN, or FHD-286. For individuals with AML that has progressed after 1 prior line of therapy, prior treatment with Azacitidine, Decitabine and VEN is allowed
Cannot have received: other (FHD-286)
Prior treatment with azacitidine, DAC, VEN, or FHD-286
Lab requirements
Blood counts
White blood cell count ≤20×10^9/L (hydroxyurea or cytarabine ≤1 g/m2 allowed to achieve this count before and up to 28 days after start of study treatment)
Kidney function
Creatinine clearance ≥30 mL/min to <45 mL/min; GFR ≥30 mL/min
Liver function
Serum total bilirubin ≤3.0×ULN, unless considered due to advanced hematologic malignancy involvement or documented Gilbert syndrome with direct bilirubin ≤1.5×ULN; AST, ALT, and alkaline phosphatase ≤3.0×ULN, unless considered due to advanced hematologic malignancy involvement
Cardiac function
Left ventricular ejection fraction (LVEF) of ≥40% by echocardiogram (ECHO)
Adequate end organ function, defined as: Adequate hepatic function...; Prothrombin time ≤1.5×ULN or international normalized ratio ≤1.4; Activated partial thromboplastin time ≤1.5×ULN; No known portal vein thrombosis; GFR ≥30 mL/min; Adequate cardiovascular, respiratory, and immune system function as evidenced by the below criterion and in the opinion of the investigator: Left ventricular ejection fraction (LVEF) of ≥40% by echocardiogram (ECHO); White blood cell count ≤20×10^9/L
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Montefiore Medical Center · The Bronx, New York
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