Actively Recruiting
FHD-286 With Low-Dose Weekly Decitabine/Venetoclax in Patients With Acute Myeloid Leukemia
Led by Montefiore Medical Center · Updated on 2026-03-03
33
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
Sponsors
M
Montefiore Medical Center
Lead Sponsor
F
Foghorn Therapeutics Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
FHD-286 With Low-Dose Weekly Decitabine/Venetoclax in Patients With Acute Myeloid Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults with newly diagnosed adverse risk Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome/AML confirmed by pathology or AML progressed after one prior therapy with at least 5% blasts
- For newly diagnosed AML: aged 75 or older, or aged 18 to 74 and not a candidate for intensive chemotherapy due to comorbidities such as ECOG performance status 2 or 3, certain heart or lung conditions, reduced kidney function, moderate liver impairment, or other investigator-assessed reasons
- Bone marrow blasts of 10% or more
- No prior treatment with hypomethylating agents or Venetoclax for the disease under study
- No other disease-directed therapy, except hydroxyurea or cytarabine, for at least 14 days before study entry
- ECOG performance status 2 or less if age 75 or older, 3 or less if age 18 to under 75, or 3 or less if AML progressed after prior therapy
- Life expectancy of 3 months or more
- Adequate liver, blood clotting, kidney, heart, lung, and immune function as defined by specific laboratory and clinical criteria
- White blood cell count 20 x 10^9/L or less (hydroxyurea or cytarabine allowed to achieve this)
- Willingness to comply with dietary and study requirements
- Ability to understand and sign informed consent and complete study procedures
You will not qualify if you...
- Acute promyelocytic leukemia
- Core binding factor AML eligible for intensive chemotherapy
- Eligible and willing for standard hypomethylating agent/Venetoclax therapy (for newly diagnosed AML)
- Known or suspected central nervous system involvement
- Prior treatment with azacitidine, Decitabine, Venetoclax, or FHD-286 (except for progressed AML after prior therapy where azacitidine, Decitabine, and Venetoclax are allowed)
- Currently pregnant or breastfeeding; women of child-bearing potential must have negative pregnancy test within 72 hours before treatment
- Planning to become pregnant within one year of treatment start
- Uncontrolled illness limiting life expectancy or study participation, including active infection (unless controlled), concurrent malignancy, significant heart conditions, liver cirrhosis, psychiatric illness, or other investigator-assessed safety concerns
- Inability to tolerate oral medication or gastrointestinal dysfunction impacting drug absorption
- Use of certain medications including strong CYP3A inhibitors or inducers, sensitive CYP3A substrates, or proton pump inhibitors without appropriate washout
- Fertile participants unwilling to use effective contraception during and after the study
- Uncontrolled active HIV infection or untreated active hepatitis B or C infections
- Known allergy or sensitivity to study drugs or their components
AI-Screening
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Trial Site Locations
Total: 1 location
1
Montefiore Medical Center
The Bronx, New York, United States, 10467
Actively Recruiting
Research Team
M
Mendel R Goldfinger, MD
CONTACT
A
Akash R Shah
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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