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AzTrials

Acute Myeloid LeukemiaPhase 1FHD-286NCT07283094

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

A Phase 1 study testing Decitabine, Venetoclax and FHD-286 in people with Acute Myeloid Leukemia and Myelodysplastic Syndrome, run by Montefiore Medical Center at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Decitabine, Venetoclax and FHD-286
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
1 siteUnited States
Study dates
3 Feb 2026to Feb 2030
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to 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 progressed after 1 prior line of therapy with ≥5% blasts
  • Inclusion Criteria 2 to 4 apply only for patients who are individuals with newly diagnosed AML:
  • 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%
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  • 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:
  • 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

Who cannot join

  • 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 or gender orientation, having undergone tubal ligation, or remaining celibate by choice, who has not undergone a documented hysterectomy or bilateral oophorectomy or has had a menses any time in the preceding 12 months [therefore not naturally post-menopausal for >12 months].)
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  • 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 infection control, they may be considered for the study. If treatment with a triazole antifungal agent is indicated, isavuconazonium sulfate should be used preferentially. If isavuconazonium sulfate cannot be used, a different triazole antifungal agent may be used. Refer to Exclusion Criterion 10a regarding strong Cytochrome P450, family 3, subfamily A (CYP3A) inhibitors
  • 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 pacemaker rhythm may be considered for the study
  • 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 permitted; however, the FHD-286 dose should be reduced to 1.5 mg QD when a strong CYP3A inhibitor is in use, and for at least 1 week or 5 half-lives of the strong CYP3A inhibitor, whichever is longer, after the end of treatment with the strong CYP3A inhibitor. The venetoclax dose should be reduced as per the United States Prescribing Information (USPI)
  • 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), beginning at the screening visit and continuing until 4 weeks after taking the last dose of DAC/VEN and 90 days after taking the last dose of FHD-286. Participants must agree to refrain from donating sperm/Ova from the screening visit through 90 days after the last dose of FHD-286
  • 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 infection, with Cluster of Differentiation 4 count (CD4) count >200 cells/µL, and on a stable regimen of antiretroviral therapy would be eligible
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Mendel R Goldfinger, MD contact

718-920-4826

mgoldfin@montefiore.org

Akash R Shah contact

718-862-8840

ashah1@montefiore.org

United States1 site, 1 recruiting

  • Montefiore Medical Center

    The Bronx, New York, 10467

    Akash Shah, 718-862-8840, ashah1@montefiore.org

    Recruiting

Other trials in United States

About this study

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.

Read the detailed description

This study evaluates the addition of FHD-286, which has a distinct mechanism of action and clinical activity in AML, to a modification of the current standard of care regimen (DAC/VEN) that has been shown to be more tolerable than and have similar clinical activity as the more intensive regimen evaluated in the VIALE-A study (see References section).

Total duration of trial intervention for each participant will vary. Participants are anticipated to remain on treatment for at least 12 weeks (induction period). As long as they are receiving benefit from treatment, participants may remain on treatment until they experience a reason for treatment discontinuation or study withdrawal. Participants may remain on study as long as they are receiving DAC and VEN, even if FHD-286 is on hold or discontinued due to toxicity.

After written informed consent is obtained from a participant, they will undergo screening evaluations within 28 days before the first dose of study treatment. Results from assessments conducted within 28 days before the first dose of study treatment may be used to fulfill screening requirements, even if they occurred before written informed consent was obtained. The first 3 to 6 participants will participate in the safety run-in portion of the study. During this portion, if ≥3 of the participants develop AEs meeting the stopping criterion during the DLT evaluation period, the study will be terminated. Thereafter, interim safety analyses will be conducted after the enrollment of every 3 participants. The first 12 weeks of treatment (cycles 1-3) are an induction period intended to produce a relatively rapid reduction in tumor burden, to a level that will permit more functional hematopoiesis, alleviating cytopenias and permitting bone marrow recovery. During the induction period, dose modifications and holds are discouraged, except in the case of severe toxicity from severe, non-hematologic adverse events. Additionally, if treatment-related myelosuppression is suspected, dose holds or reductions may be implemented, upon agreement with the principal investigator (PI). If the participant is receiving clinical benefit (at minimum, stable disease) after 12 weeks of treatment, they will have the option of continuing their treatment regimen during the long-term treatment period. The goal of the long-term treatment period is to continue to provide clinical benefit via disease control and hematopoietic improvement. Each participant may continue treatment until they experience a reason for treatment discontinuation. Upon discontinuation of treatment, each participant will be asked to undergo an end-of-treatment evaluation. Thirty days after discontinuation of study treatment, each participant will be asked to undergo a safety follow-up evaluation. Participants will then be contacted approximately every 2 months for long-term follow-up to assess survival status, receipt and type of subsequent anticancer therapy, and disease status.

Dose-limiting toxicities will be assessed during the first cycle (first 28 days) of treatment.

Being tested
Decitabine, Venetoclax, FHD-286
Medical subject headings
Leukemia, Myeloid, Acute, Myelodysplastic Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DecitabineDrug

    Decitabine: 0.2 mg/kg/day subcutaneously once weekly (QW) (days 1, 8, 15, 22 [±3 days] of each 28-day cycle)

    • A second weekly dose may be added if the investigator determines that more rapid debulking is required for a participant with high disease burden. The 2 weekly DAC doses should, preferably, be given on consecutive days

  • VenetoclaxDrug

    Venetoclax: 400 mg orally (PO) (tablets) QW, concurrent with the first weekly DAC dose (days 1, 8, 15, and 22 [±1 day] of each 28-day cycle)

    • Refer to the United States Prescribing Information (USPI) ("steady daily dose") for details regarding VEN dosage modifications. When decitabine is held, venetoclax should also be held. Based on best clinical judgment, the investigator may continue decitabine while withholding VEN for several doses to allow for improved count recovery
    • If treatment with a P-gp inhibitor or triazole antifungal agent classified as a moderate CYP3A inhibitor is medically necessary, reduce the VEN dose by at least 50%
    • If treatment with posaconazole is medically necessary, reduce the VEN dose to 70 mg
    • If treatment with another triazole antifungal agent classified as a strong CYP3A inhibitor is medically necessary, reduce the VEN dose to 100 mg

  • FHD-286Drug

    FHD-286: 2.5 or 5 mg (based on assigned dose group) PO (capsules) once daily (QD) 5 days/week (days 3-7, 10-14, 17-21, and 24-28 of each 28-day cycle)

    If acceptable safety and tolerability are observed at the end of cycle 1 with at least 3 DLT-evaluable participants in cohort 1 (FHD-286 2.5 mg QD), the dose of FHD-286 will be escalated to 5 mg QD for cohort 2. Doses of DAC and VEN will not change

    The 2 non-dosing days must be the day of and the day after the VEN dose

    • If necessary to improve tolerability and/or reduce toxicity, frequency of FHD-286 dosage may be reduced to 4 days/week
    • FHD-286 dose level will be escalated/de-escalated as described in protocol
    • If treatment with a strong CYP3A inhibitor is medically necessary, discussion with the PI is required and the FHD-286 dose should be reduced to 1.5 mg QD. Dose interruption or discontinuation of FHD-286 may also be necessary
    • See protocol for information on prohibited concomitant therapies when medically necessary
Study groups in NCT07283094
Study groupRoleWhat they receive
Decitabine, Venetoclax, and FHD-286ExperimentalAdministration: * Decitabine is reconstituted with 5 mL of sterile water and given by subcutaneous (SC) injection at the investigational site. * Venetoclax is taken as a tablet provided by the investigational site pharmacy or another authorized specialty pharmacy. * FHD-286 is taken as a capsule provided by the investigational site pharmacy.
Receives: Drug: Decitabine; Drug: Venetoclax; Drug: FHD-286

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose-limiting toxicities (DLTs)

    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.

    Measured: Through the 12-week induction period

  2. Frequency and severity of the adverse event of special interest (AESI)

    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.

    Measured: Through the 12-week induction period

  3. Percentage of participants who are able to continue treatment

    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.

    Measured: After 12-week induction period

Secondary outcomes (6)

  1. Hemoglobin (Hgb) laboratory level for safety assessments

    Hemoglobin laboratory values outside of normal ranges defined as 12.2 - 15.3 g/dL. Hgb counts will be monitored as part of treatment response criteria. Values outside of normal ranges will be summarized.

    Measured: Weekly during 12-week induction period

  2. Platelet (Plt) laboratory level for safety assessments

    Platelet laboratory values outside of normal ranges defined as 150 - 400 thousands per microliter (k/uL). Along with other laboratory values, treatment-emergent decreases in platelet counts will be monitored as part of dose modification guidelines and elevated platelet counts will be monitored as part of differentiation syndrome criteria. Platelet counts will also be monitored as part of treatment response criteria. Values outside of normal ranges will be summarized.

    Measured: Weekly during 12-week induction period

  3. Absolute Neutrophil Count (ANC) laboratory level for safety assessments

    Absolute neutrophil count laboratory values outside of normal ranges defined as 1.80 - 7.70 k/uL. Along with other laboratory values, treatment-emergent decreases in ANC counts will be monitored as part of dose modification guidelines and elevated ANC counts will be monitored as part of differentiation syndrome criteria. ANC counts will also inform the need for supportive concomitant therapy. ANC counts will also be monitored as part of treatment response criteria. Values outside of normal ranges will be summarized.

    Measured: Weekly during 12-week induction period

  4. Overall response rate (ORR)

    Overall response rate is defined as the rate of complete remission (CR), CR with incomplete hematologic recovery, morphologic leukemia-free state, and partial remission, based on ELN 2022 criteria. ORR will be summarized by cohort.

    Measured: End of Cycle 1 (28 days) and end of Cycle 2 (56 days)

  5. Duration of response

    Duration of response is defined as the time from the first documentation of a response until the first documentation of disease progression or relapse, or death.

    Measured: Up to 2 years

  6. Percentage of participants who achieve Complete Remission

    Complete remission is defined as bone marrow blasts <5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; ANC ≥1.0×10^9/L (1000/µL); platelet count ≥100×10^9/L (100,000/µL). The percentage of participants who achieve Complete Remission will be summarized by cohort and disease state.

    Measured: End of Cycle 1 (28 days), end of Cycle 2 (56 days) and Cycle 3 (84 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Dec 2025
  2. Study start3 Feb 2026
  3. Primary completionMay 2028 (estimated)
  4. Study completionFeb 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
The study will enroll approximately 3-6 participants per cohort using a 3+3 design, resulting in a total of approximately 6-12 participants. During dose escalation, up to 5 additional participants per dose level may be enrolled at dose levels that have already been cleared. After a dose(s) has been selected for further study, additional participants may be enrolled to further explore safety or preliminary clinical activity.
Masking
None (open label)
Enrolment
33 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07283094
Sponsor's protocol ID
2025-16661
Other IDs
2516661-FHD-286, 2025
Acronym
FHD-286
Status last verified
Feb 2026
First submitted
2 Dec 2025
Last updated
3 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Dohner H, Wei AH, Appelbaum FR, Craddock C, DiNardo CD, Dombret H, Ebert BL, Fenaux P, Godley LA, Hasserjian RP, Larson RA, Levine RL, Miyazaki Y, Niederwieser D, Ossenkoppele G, Rollig C, Sierra J, Stein EM, Tallman MS, Tien HF, Wang J, Wierzbowska A, Lowenberg B. Diagnosis and management of AML in adults: 2022 recommendations from an international expert panel on behalf of the ELN. Blood. 2022 Sep 22;140(12):1345-1377. doi: 10.1182/blood.2022016867.

    PubMed 35797463

  • DiNardo CD, Jonas BA, Pullarkat V, Thirman MJ, Garcia JS, Wei AH, Konopleva M, Dohner H, Letai A, Fenaux P, Koller E, Havelange V, Leber B, Esteve J, Wang J, Pejsa V, Hajek R, Porkka K, Illes A, Lavie D, Lemoli RM, Yamamoto K, Yoon SS, Jang JH, Yeh SP, Turgut M, Hong WJ, Zhou Y, Potluri J, Pratz KW. Azacitidine and Venetoclax in Previously Untreated Acute Myeloid Leukemia. N Engl J Med. 2020 Aug 13;383(7):617-629. doi: 10.1056/NEJMoa2012971.

    PubMed 32786187

  • Aldoss I, Yang D, Aribi A, Ali H, Sandhu K, Al Malki MM, Mei M, Salhotra A, Khaled S, Nakamura R, Snyder D, O'Donnell M, Stein AS, Forman SJ, Marcucci G, Pullarkat V. Efficacy of the combination of venetoclax and hypomethylating agents in relapsed/refractory acute myeloid leukemia. Haematologica. 2018 Sep;103(9):e404-e407. doi: 10.3324/haematol.2018.188094. Epub 2018 Mar 15. No abstract available.

    PubMed 29545346

  • Pratz KW, Jonas BA, Pullarkat V, Thirman MJ, Garcia JS, Dohner H, Recher C, Fiedler W, Yamamoto K, Wang J, Yoon SS, Wolach O, Yeh SP, Leber B, Esteve J, Mayer J, Porkka K, Illes A, Lemoli RM, Turgut M, Ku G, Miller C, Zhou Y, Zhang M, Chyla B, Potluri J, DiNardo CD. Long-term follow-up of VIALE-A: Venetoclax and azacitidine in chemotherapy-ineligible untreated acute myeloid leukemia. Am J Hematol. 2024 Apr;99(4):615-624. doi: 10.1002/ajh.27246. Epub 2024 Feb 11.

    PubMed 38343151

  • Goldfinger M, Mantzaris I, Shastri A, Saunthararajah Y, Gritsman K, Sica RA, Kornblum N, Shah N, Levitz D, Rockwell B, Shapiro LC, Gupta R, Pradhan K, Xue X, Munoz A, Dhawan A, Fehn K, Comas M, Verceles JA, Jonas BA, Kambhampati S, Shi Y, Braunschweig I, Cooper DL, Konopleva M, Feldman EJ, Verma A. A weekly low-dose regimen of decitabine and venetoclax is efficacious and less myelotoxic in a racially diverse cohort. Blood. 2024 Nov 28;144(22):2360-2363. doi: 10.1182/blood.2024025834.

    PubMed 39316768

  • Velcheti V, Schrump D, Saunthararajah Y. Ultimate Precision: Targeting Cancer but Not Normal Self-replication. Am Soc Clin Oncol Educ Book. 2018 May 23;38:950-963. doi: 10.1200/EDBK_199753.

    PubMed 30231326

  • Saunthararajah Y, Sekeres M, Advani A, Mahfouz R, Durkin L, Radivoyevitch T, Englehaupt R, Juersivich J, Cooper K, Husseinzadeh H, Przychodzen B, Rump M, Hobson S, Earl M, Sobecks R, Dean R, Reu F, Tiu R, Hamilton B, Copelan E, Lichtin A, Hsi E, Kalaycio M, Maciejewski J. Evaluation of noncytotoxic DNMT1-depleting therapy in patients with myelodysplastic syndromes. J Clin Invest. 2015 Mar 2;125(3):1043-55. doi: 10.1172/JCI78789. Epub 2015 Jan 26.

    PubMed 25621498

  • Awada H, Mahfouz RZ, Kishtagari A, Kuzmanovic T, Durrani J, Kerr CM, Patel BJ, Visconte V, Radivoyevitch T, Lichtin A, Carraway HE, Maciejewski JP, Saunthararajah Y. Extended experience with a non-cytotoxic DNMT1-targeting regimen of decitabine to treat myeloid malignancies. Br J Haematol. 2020 Mar;188(6):924-929. doi: 10.1111/bjh.16281. Epub 2019 Nov 17.

    PubMed 31736067

  • Gu X, Tohme R, Tomlinson B, Sakre N, Hasipek M, Durkin L, Schuerger C, Grabowski D, Zidan AM, Radivoyevitch T, Hong C, Carraway H, Hamilton B, Sobecks R, Patel B, Jha BK, Hsi ED, Maciejewski J, Saunthararajah Y. Decitabine- and 5-azacytidine resistance emerges from adaptive responses of the pyrimidine metabolism network. Leukemia. 2021 Apr;35(4):1023-1036. doi: 10.1038/s41375-020-1003-x. Epub 2020 Aug 7.

    PubMed 32770088

  • Zavras PD, Shastri A, Goldfinger M, Verma AK, Saunthararajah Y. Clinical Trials Assessing Hypomethylating Agents Combined with Other Therapies: Causes for Failure and Potential Solutions. Clin Cancer Res. 2021 Dec 15;27(24):6653-6661. doi: 10.1158/1078-0432.CCR-21-2139. Epub 2021 Sep 22.

    PubMed 34551907

  • DiNardo CD, Fathi AT, Kishtagari A, Bhalla KN, Quintas-Cardama A, Reilly SA, Almon C, Patriquin C, Nabhan S, Healy K, Hickman D, Collins MP, Khalil A, Corrigan D, Zhao T, Piel J, Lyons K, Horrigan K, Schuck V, Martin P, Elliott G, Lahr DL, Bosinger M, D'Aco K, Smolen GA, Hentemann M, Loghavi S, Agresta S, Savona MR, Stein EM. A Phase I Study of FHD-286, a Dual BRG1/BRM (SMARCA4/SMARCA2) Inhibitor, in Patients with Advanced Myeloid Malignancies. Clin Cancer Res. 2025 Jun 13;31(12):2327-2338. doi: 10.1158/1078-0432.CCR-24-3790.

    PubMed 40238563

  • Jonas BA, Pollyea DA. How we use venetoclax with hypomethylating agents for the treatment of newly diagnosed patients with acute myeloid leukemia. Leukemia. 2019 Dec;33(12):2795-2804. doi: 10.1038/s41375-019-0612-8. Epub 2019 Oct 18.

    PubMed 31628431

  • Winters AC, Gutman JA, Purev E, Nakic M, Tobin J, Chase S, Kaiser J, Lyle L, Boggs C, Halsema K, Schowinsky JT, Rosser J, Ewalt MD, Siegele B, Rana V, Schuster S, Abbott D, Stevens BM, Jordan CT, Smith C, Pollyea DA. Real-world experience of venetoclax with azacitidine for untreated patients with acute myeloid leukemia. Blood Adv. 2019 Oct 22;3(20):2911-2919. doi: 10.1182/bloodadvances.2019000243.

    PubMed 31648312

  • Abaza Y, Winer ES, Murthy GSG, Shallis RM, Matthews AH, Badar T, Geramita EM, Kota VK, Swaroop A, Doukas P, Bradshaw D, Helenowski IB, Liu Y, Zhang H, Im A, Litzow MR, Perl AE, Atallah E, Altman JK. Clinical outcomes of hypomethylating agents plus Venetoclax as frontline treatment in patients 75 years and older with acute myeloid leukemia: Real-world data from eight US academic centers. Am J Hematol. 2024 Apr;99(4):606-614. doi: 10.1002/ajh.27231. Epub 2024 Feb 11.

    PubMed 38342997

  • Brandwein J, Page D, Liew E, Hnatiuk M, Bolster L, Hamilton M, Sawler D, Wang P. A Real-World Evaluation of Frontline Treatment for Acute Myeloid Leukemia With Azacitidine Plus Venetoclax. Clin Lymphoma Myeloma Leuk. 2025 Jul;25(7):e435-e442. doi: 10.1016/j.clml.2025.01.024. Epub 2025 Feb 1.

    PubMed 40023757

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Decitabine, Venetoclax and FHD-286 in people with Acute Myeloid Leukemia and Myelodysplastic Syndrome, run by Montefiore Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 32 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Mendel R Goldfinger, MD (718-920-4826, mgoldfin@montefiore.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-limiting toxicities (DLTs) (time frame: Through the 12-week induction period). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07283094, which also lists 27 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2026.

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