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New treatment option for Acute Myeloid Leukemia
Official title FHD-286 With Low-Dose Weekly Decitabine/Venetoclax in Patients With Acute Myeloid Leukemia
ClinicalTrials.gov ID: NCT07283094
What this study is testing
What is Decitabine?
Decitabine is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for acute myeloid leukemia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Newly diagnosed adverse risk AML, including Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML), per the 2022 ELN criteria, with a...
- Aged ≥75 years, or aged 18-74 years and either refuse to receive intensive induction chemotherapy or are not a candidate for intensive induction...
- Eastern Cooperative Oncology Group performance status (ECOG PS) of 2 or 3
- Cardiac history of congestive heart failure requiring treatment, ejection fraction ≤50%, or chronic stable angina pectoris
- Diffusing capacity of the lung for carbon monoxide ≤65% or forced expiratory volume in 1 second ≤65%
You likely can't join if
- Acute promyelocytic leukemia
- Core binding factor AML who is a candidate for intensive chemotherapy
- Eligible for and willing to receive standard HMA/VEN therapy (only applicable for individuals with newly diagnosed AML)
- Evidence (or suspicion) of central nervous system (CNS) involvement
- Prior treatment with azacitidine, DAC, VEN, or FHD-286. For individuals with AML that has progressed after 1 prior line of therapy, prior treatment...
- Currently pregnant or breast-feeding. Women of child-bearing potential (WOCBP) must have negative serum pregnancy test within 72 hours before...
See the full eligibility criteria
Who can join
- Newly diagnosed adverse risk AML, including Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML), per the 2022 ELN criteria, with a histopathologic diagnosis confirmed by hematopathology review OR AML that has...
- Aged ≥75 years, or aged 18-74 years and either refuse to receive intensive induction chemotherapy or are not a candidate for intensive induction chemotherapy due to one or more of the following comorbidities:
- Eastern Cooperative Oncology Group performance status (ECOG PS) of 2 or 3
- Cardiac history of congestive heart failure requiring treatment, ejection fraction ≤50%, or chronic stable angina pectoris
- Diffusing capacity of the lung for carbon monoxide ≤65% or forced expiratory volume in 1 second ≤65%
- Creatinine clearance ≥30 mL/min to \<45 mL/min
- Moderate hepatic impairment with total bilirubin \>1.5 to ≤3.0×upper limit of normal (ULN)
- Any other comorbidity that the investigator judges to be incompatible with intensive chemotherapy
- Bone marrow blasts ≥10%
- Have not received a hypomethylating agent (HMA) or VEN for their disease under study
- No other disease-directed therapy, except hydroxyurea or cytarabine, and including experimental or investigational drug therapy, for at least 14 days before study entry
- 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
- Life expectancy ≥3 months
- Adequate end organ function, defined as:
- Adequate hepatic function, including:
- 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
- Prothrombin time ≤1.5×ULN or international normalized ratio ≤1.4
- 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
- No known portal vein thrombosis
- 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)
- Adequate cardiovascular, respiratory, and immune system function as evidenced by the below criterion and in the opinion of the investigator: a. Left ventricular ejection fraction (LVEF) of ≥40% by echocardiogram (ECHO)
- White blood cell count ≤20×10\^9/L (treatment with hydroxyurea or cytarabine ≤1 g/m2 to achieve this count is allowed before the start of study treatment and for up to 28 days after the start of study treatment)
- Agree to abide by dietary and other considerations required during the study
- Ability to understand and willingness to sign a written informed consent form and complete study-related procedures
What rules you out
- Acute promyelocytic leukemia
- Core binding factor AML who is a candidate for intensive chemotherapy
- Eligible for and willing to receive standard HMA/VEN therapy (only applicable for individuals with newly diagnosed AML)
- Evidence (or suspicion) of central nervous system (CNS) involvement
- 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
- Currently pregnant or breast-feeding. Women of child-bearing potential (WOCBP) must have negative serum pregnancy test within 72 hours before treatment start. (NOTE: WOCBP is any biological female, regardless of sexual...
- Planning to become pregnant within 1 year after start of study treatment
- Uncontrolled intercurrent illness that could limit life expectancy or ability to complete study correlates. This includes, but is not limited to:
- Ongoing or active infection. Because patients with myeloid malignancies are prone to infections, if individuals are actively being treated with appropriate antibiotics or antifungal agents with clinical evidence of...
- Uncontrolled concurrent malignancy
- Heart rate-corrected QT interval (QTc) by Fridericia method (QTcF) \>470 milliseconds (ms) or other factors that increase the risk of QTc prolongation. Participants with QTcF \>470 ms and bundle branch block and/or...
- Congestive heart failure of New York Heart Association class III/IV. Individuals with compensated heart failure are permitted
- Unstable angina pectoris
- New or unstable cardiac arrhythmia. Patients with stable or controlled arrhythmias may be considered for the study.
- Decompensated liver cirrhosis (Child-Pugh score ≥12 or a Model for End-Stage Liver Disease (MELD) score ≥21)
- Psychiatric illness/social situation that would limit compliance with study requirements
- Any other prior or ongoing condition that, in the opinion of the investigator, could adversely affect the safety of the individual or impair the assessment of study results
- Unable to tolerate administration of oral medication or has gastrointestinal dysfunction that would preclude adequate absorption, distribution, metabolism, or excretion of FHD-286.
- Taking medications classified as:
- Strong CYP3A inhibitors. Individuals must have stopped treatment with strong CYP3A inhibitors at least 1 week or 5 half-lives, whichever is longer, before the first dose of study drug. Strong CYP3A inhibitors may be...
- Strong CYP3A inducers. Individuals must have stopped treatment with strong CYP3A inducers at least 2 weeks or 5 half-lives, whichever is longer, before the first dose of study drug
- Sensitive CYP3A substrates with narrow therapeutic indices
- Taking proton pump inhibitors (PPIs). Administration of PPIs must be stopped or switched to another acid-reducing agent (e.g., antacids or H2 blockers) at least 7 days before study entry
- WOCBP sexually active with male partners and fertile males sexually active with WOCBP unwilling to agree to use dual contraceptive measures (i.e., hormonal or barrier method of birth control, abstinence, condom)...
- Uncontrolled active HIV infection, as this will further increase the risk for opportunistic infections. However, individuals with HIV with undetectable viral load by polymerase chain reaction, without opportunistic...
- Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, unless the individual has a sustained viral response to HCV treatment or immunity to prior HBV infection
- Known allergy or hypersensitivity to any component of DAC, VEN, or FHD-286 formulations
The study team makes the final eligibility decision.
Where it's taking place
- The Bronx, New York, United States
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include The Bronx, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.