Actively Recruiting
Venetoclax and Bomedemstat in Patients With Relapsed/Refractory Acute Myeloid Leukemia
Led by Terrence J Bradley, MD · Updated on 2026-01-08
18
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
Sponsors
T
Terrence J Bradley, MD
Lead Sponsor
I
Imago BioSciences, Inc., a subsidiary of Merck & Co., Inc., (Rahway, New Jersey USA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study aims to learn about the safety, tolerability, and different dose levels' safety profiles of Venetoclax and Bomedemstat (VenBom) combination therapy in participants with relapsed or refractory acute myeloid leukemia.
CONDITIONS
Official Title
Venetoclax and Bomedemstat in Patients With Relapsed/Refractory Acute Myeloid Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of relapsed or refractory acute myeloid leukemia (AML) after failing at least one standard front-line therapy, diagnosed according to WHO criteria regardless of subtype or treatment history
- Adults aged 18 years or older
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
- Laboratory criteria including total bilirubin ≤ 2 times upper limit of normal except for Gilbert's syndrome, ALT and AST ≤ 3 times upper limit of normal, creatinine clearance > 50 ml/min, hemoglobin > 8 g/dL (transfusions allowed), white blood cell count < 25,000 cells/μL before first dose, and platelet count ≥ 20,000 cells/μL before first dose (transfusions allowed)
- Suitable venous access for blood sampling
- Estimated life expectancy sufficient for at least 3 months of treatment
- Voluntary written informed consent
- Female patients who are postmenopausal, surgically sterile, or of childbearing potential agreeing to use specified contraception or true abstinence during and up to 4 months after treatment
- Male patients agreeing to use effective barrier contraception or true abstinence during and up to 4 months after treatment
- Willingness to undergo bone marrow evaluation and blood sampling as required by the protocol
You will not qualify if you...
- Treatment with significant metabolic enzyme inducers within 14 days before starting study drug
- Diagnosis of acute promyelocytic leukemia (APL)
- Use of investigational products, anti-cancer therapy, or radiotherapy within 14 days before Cycle 1 Day 1, except hydroxyurea to control blast counts during Cycle 1
- Candidates for standard or potentially curative treatments who are eligible and willing to receive them
- Major surgery within 14 days before first dose or planned surgery during the study
- Grade 2 or higher diarrhea despite optimal care within 7 days before Cycle 1 Day 1
- Known significant cardiopulmonary diseases including uncontrolled high blood pressure, cardiomyopathy or recent ischemic heart disease, congestive heart failure Class III/IV or recent decompensation, moderate to severe valvular disease, severe COPD, interstitial lung disease or pulmonary fibrosis
- Active uncontrolled severe infections
- Uncontrolled HIV infection
- Positive hepatitis B surface antigen or active hepatitis C infection without undetectable viral load
- Females of childbearing potential refusing required contraception or abstinence
- Sexually active males refusing required barrier contraception or abstinence
- Female patients lactating or breastfeeding or with positive pregnancy tests
- Patients intending to donate eggs or sperm during or shortly after study
- Serious medical or psychiatric illness interfering with study completion
- Symptomatic central nervous system involvement
- Diagnosed or treated for another malignancy within 2 years, except certain skin cancers
- Known hepatic cirrhosis or severe liver impairment
- Use or expected use of prohibited medications during treatment
- Uncontrolled bleeding or clotting disorders
- Life-threatening illnesses unrelated to cancer
- Impaired decision-making capacity
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Miami
Miami, Florida, United States, 33136
Actively Recruiting
Research Team
A
Alessia Zoso, PhD
CONTACT
T
Terrence J Bradley, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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