Clinical Trial

FHD-286 With Low-Dose Weekly Decitabine/Venetoclax in Patients With Acute Myeloid Leukemia

Study acronym: FHD-286
Recruiting Phase 1
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Summary
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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-12-02; most recent amendment 2026-02-27.
Status change: Not Yet Recruiting → Recruiting 2026-02-27
Trial Details
NCT Number NCT07283094
Lead Sponsor Montefiore Medical Center
Collaborators: Foghorn Therapeutics Inc.
Conditions Acute Myeloid Leukemia, Myelodysplastic Syndrome
Enrollment 33 participants
Start Date 2026-02-03
Primary Completion 2028-05 (estimated)
Study Completion 2030-02 (estimated)
Updated on ClinicalTrials.gov 2026-03-03