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FHD-286 with Decitabine/Venetoclax for Acute Myeloid Leukemia

This study is testing a new combination of medicines for people with Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS/AML). It combines FHD-286 with two existing drugs, Decitabine and Venetoclax. You might be able to join if you have newly diagnosed AML that is considered high-risk, or if your AML has come back after one previous treatment. The researchers want to see if this new combination is safe, how well it's tolerated, and if people can stay on the treatment for a longer time. They plan to enroll 33 participants.

Study design
This is an early-stage study (Phase not specified) that is not randomized, meaning everyone receives the same treatment. It is an open-label study, so both you and your doctors will know which medications you are receiving.
What's involved
You will receive Decitabine once a week, Venetoclax once a week, and FHD-286 five days a week, all in 28-day cycles. You are expected to be on treatment for at least 12 weeks, and potentially longer if you are benefiting.
Compensation
Not stated in the trial record.
Follow-up
The study will measure how often and how severe side effects are, and if participants can continue treatment, through a 12-week induction period and after that period.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07283094

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Montefiore Medical Center
~33 participants
Updated 2026-03-03 on ClinicalTrials.gov
What's tested:DecitabineVenetoclaxFHD-286

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Dose-limiting toxicities (DLTs)
Measured over Through the 12-week induction period
+2 more outcomes measured

Conditions

Acute Myeloid Leukemia
Myelodysplastic Syndrome

Explore related trials

Acute Myeloid LeukemiaMyelodysplastic Syndrome

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • Mendel R Goldfinger, MD · PRINCIPAL_INVESTIGATOR · Montefiore Medical Center

Who to contact

Mendel R Goldfinger, MD
[email protected]
718-920-4826
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

75 years: ≤2
18 years to \<75 years: ≤3 2. AML that has progressed after 1 prior line of therapy (Any age):
3 if R/R AML 7. Life expectancy ≥3 months 8. Adequate end organ function, defined as:
Serum total bilirubin ≤3.0×ULN, unless considered due to advanced hematologic malignancy involvement or documented Gilbert syndrome with direct bilirubin ≤1.5×ULN
Aspartate aminotransferase, alanine aminotransferase, and alkaline phosphatase ≤3.0×ULN, unless considered due to advanced hematologic malignancy involvement 2. Prothrombin time ≤1.5×ULN or international normalized ratio ≤1.4 3. Activated partial thromboplastin time ≤1.5×ULN Note: Individuals who have been receiving a stable dose of anticoagulation therapy without bleeding episodes for ≥12 weeks may be considered for the study 4. No known portal vein thrombosis 5. Glomerular filtration rate (GFR) ≥30 mL/min (based on a contemporary, widely accepted, and clinically applicable equation that estimates GFR or a measure of GFR) 9. Adequate cardiovascular, respiratory, and immune system function as evidenced by the below criterion and in the opinion of the investigator:

What this trial measures

  • Dose-limiting toxicities (DLTs)Through the 12-week induction period

    Dose limiting toxicity is defined as any adverse event (AE) that occurs during the DLT evaluation period that also meets any one of the criteria for hematologic and non-hematologic AEs as defined by the protocol and determined by the Data and Safety Monitoring Committee (DSMC), with input from the clinical study team. All AEs that cannot clearly be determined to be unrelated to FHD-286 or the combination of FHD-286 with DAC and VEN will be considered relevant to determining DLTs and any other emergent toxicities that are not explicitly defined by the DLT criteria to determine if any warrant a DLT designation, including toxicities that begin after the DLT evaluation period will be reviewed by the DSMC with input from the clinical study team. The percentage of participants with DLTs will be summarized by cohort.

  • Frequency and severity of the adverse event of special interest (AESI)Through the 12-week induction period

    Differentiation syndrome is an adverse event of special interest for FHD-286. Suspected or confirmed differentiation syndrome will be reported, at minimum, as an important medical event. All Grade ≥2 events of Differentiation syndrome will be reported. The percentage of participants with DLTs will be summarized by cohort.

  • Percentage of participants who are able to continue treatmentAfter 12-week induction period

    The percentage of participants who are able to continue treatment without dose interruptions, reductions, or delays during the 12-week induction period will be summarized. Dose interruptions and delays are defined as delaying or interrupting treatment due to toxicity or intolerability for \>2 weeks.