Acute Myeloid LeukemiaPhase 1VenBomNCT05597306
Venetoclax and Bomedemstat in Patients With Relapsed/Refractory Acute Myeloid Leukemia
A Phase 1 study testing Bomedemstat and Venetoclax in people with Acute Myeloid Leukemia and Refractory Acute Myeloid Leukemia, run by Terrence J Bradley, MD at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia, Acute Myeloid Leukemia, in Relapse
- What is being tested?
- Bomedemstat and Venetoclax
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Nov 2022to 19 Nov 2026
- 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
- Confirmed diagnosis of one of the following:
- 1. Relapsed/refractory Acute Myeloid Leukemia (AML) following failure of at least one standard, front-line therapy. Patients must have an AML diagnosis per the World Health Organization (WHO) criteria, regardless of etiology, sub-type or treatment history.
- Adult male or female patients 18 years of age or older.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2 (Appendix A: Performance Status Scales).
- Patients must satisfy the following laboratory criteria:
- Total bilirubin ≤ 2 upper limit of normal (ULN) except in patients with Gilbert's syndrome. Patients with Gilbert's syndrome may enroll if direct bilirubin is ≤ 1.5 x ULN of the direct bilirubin.
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- Alanine aminotransferase (ALT) and aspartate transaminase (AST) must be ≤ 3 × ULN.
- Calculated creatinine clearance > 50 ml/min.
- Hemoglobin > 8 g/dL (prior red blood cell (RBC) transfusion allowed). Patients may be transfused to achieve this value. Elevated indirect bilirubin due to posttransfusion hemolysis is allowed.
- White blood cell (WBC) count < 25,000 cells/μL before administration of VenBom on Cycle 1 Day 1. Note: During Cycle 1 only, hydroxyurea may be used to control the level of circulating leukemic blast cell counts to not lower than 10,000 cells/μL.
- Platelet count ≥ 20,000 cells/μL before administration of VenBom on Cycle 1 Day 1. Note: Transfusions permitted to achieve this threshold.
- Suitable venous access to allow for all study related-blood sampling (safety and research).
- Estimated life expectancy, in the judgment of the Investigator, that will permit receipt of at least 3 months of treatment.
- Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care or other benefits to which they are entitled to receive.
- Female patients who:
- Are postmenopausal (No menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of menorrhoea, a single FSH measurement is insufficient.), OR
- Are surgically sterile, OR
- If they are of childbearing potential: Agree to practice 1 highly effective method and 1 additional effective (barrier) method of contraception, at the same time, from the time of signing the informed consent through 4 months after the last dose of study drug (female and male condoms should not be used together), OR Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient. (Periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception).
- Male patients, even if surgically sterilized (i.e., status post-vasectomy), who:
- Agree to practice effective barrier contraception during the entire study treatment period and through 4 months after the last dose of study drug (female and male condoms should not be used together), OR
- Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient. (Periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods for the female partner] withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception).
- Amenable to bone marrow evaluation and peripheral blood sampling at protocol required collection time-points.
Who cannot join
- Treatment with clinically significant metabolic enzyme inducers within 14 days before the first dose of the study drug. (Refer to Section 6.3 for instruction on use of strong or moderate Cytochrome P450 (CYP3A) inhibitors/inducers.)
- Diagnosis of acute promyelocytic leukemia (APL)
- Therapy with any investigational products, anti-neoplastic therapy, or radiotherapy within 14 days prior to Cycle 1, Day 1. Exception: Patients actively receiving hydroxyurea are eligible and may continue to receive hydroxyurea to control the level of circulating leukemic blast counts to not lower than 10,000 cells/μL during Cycle 1 of protocol treatment.
- Candidates for standard and/or potentially curative treatments (a candidate is defined as a patient that is both eligible and willing to have these treatments).
- Major surgery within 14 days before the first dose of study drug or a scheduled surgery during the study period.
- Grade 2 or higher diarrhea as defined by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 despite optimal anti-diarrheal supportive care within 7 days prior to Cycle 1, Day 1.
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- Known cardiopulmonary disease defined as one of the following:
- Uncontrolled high blood pressure (i.e., systolic blood pressure > 180 mm Hg, diastolic blood pressure > 95 mm Hg)
- Cardiomyopathy or history of ischemic heart disease. Exception: Patients with ischemic heart disease who have received treatment for acute coronary syndrome (ACS), myocardial infarction (MI), and/or coronary artery revascularization surgery (e.g., coronary artery bypass graft, stent) greater than 6 months before screening and who are without cardiac symptoms may enroll.
- Congestive heart failure (New York Heart Association (NYHA) Class III or IV or Class II with a recent decompensation requiring hospitalization or referral to a heart failure clinic within 4 weeks before screening).
- Moderate to severe aortic and/or mitral stenosis or other valvulopathy (ongoing).
- Known moderate to severe chronic obstructive pulmonary disease (COPD), interstitial lung disease, and pulmonary fibrosis.
- Active uncontrolled infection or severe infectious disease, such as severe pneumonia, meningitis, or septicemia.
- Uncontrolled human immunodeficiency virus (HIV), defined as dateable viral load.
- Known hepatitis B surface antigen seropositive. (Note: Patients who have isolated positive hepatitis B core antibody (i.e., in the setting of negative hepatitis B surface antigen and negative hepatitis B surface antibody) must have an undetectable hepatitis B viral load if they are to participate in this study.)
- Known active hepatitis C infections. (Note: Patients who are hepatitis C surface antigen-positive are eligible if they have an undetectable hepatitis C viral load.)
- Females of child-bearing potential who refuse to either practice 2 effective methods of contraception at the same time or abstain from heterosexual intercourse from the time of signing the informed consent through 30 days after the last dose of study drug.
- Sexually active males who refuse to practice effective barrier contraception during the entire study treatment period and through 4 months after the last dose of study drug (includes males surgically sterilized - i.e., status post vasectomy).
- Female patients who are both lactating and breastfeeding or have a positive serum pregnancy test during the screening period or a positive urine pregnancy test on Day 1 before first dose of study drug.
- Female patients who intend to donate eggs (ova) during the course of this study or within 4 months after receiving their last dose of study drug.
- Male patients who intend to donate sperm during the course of this study or within 4 months after receiving their last dose of study drug.
- Any serious medical or psychiatric illness that could, in the Investigator's opinion, potentially interfere with the completion of study procedures.
- Symptomatic central nervous system (CNS) involvement.
- Diagnosed or treated for another malignancy within 2 years before randomization or previously diagnosed with another malignancy and have any evidence of residual disease. Patients with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone resection.
- Known hepatic cirrhosis or severe pre-existing hepatic impairment.
- Current use of a prohibited medication (Section 4.12) or expected to require any of these medications during treatment with study drug.
- Patients with uncontrolled coagulopathy or bleeding disorder.
- Life-threatening illness unrelated to cancer.
- Patients with impaired decision-making capacity.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Miami
Miami, Florida, 33136
Alessia Zoso, PhD, 305-243-2373, azoso@med.miami.edu
Terrence Bradley, MD, 305-243-1000, tbradley@med.miami.edu
About this study
Official title: VenBom: A Phase 1 Study of Bomedemstat (IMG-7289), a Novel Inhibitor of Lysine-Specific Demethylase 1 (LSD1), in Combination With Venetoclax in Adult Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML)
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
- Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia, Acute Myeloid Leukemia, in Relapse
- Being tested
- Bomedemstat, Venetoclax
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BomedemstatDrug
Also called IMG-7289
Bomedemstat will be administered orally once daily via capsule.
VenetoclaxDrug
Also called Venclexta
Venetoclax will be administered orally once daily via tablet.
| Study group | Role | What they receive |
|---|---|---|
| Part 1: VenBom Dose Escalation/De-Escalation Cohort | Experimental | Participants in this group will receive Venetoclax and Bomedemstat (VenBom) in a dose escalation/de-escalation design to determine the maximum tolerated dose (MTD). Participants will receive VenBom for 21 days on (Days 1-21) and seven days off (Days 22-28) during a 28-day cycle for three months. Doses will be administered as follows:
* Dose Level -2: 0.375 mg/kg daily (d) Bomedemstat and 200 mg/d Venetoclax;
* Dose Level -1: 0.75 mg/kg/d Bomedemstat and 200 mg/d Venetoclax;
* Dose Level 1 (Starting): 1.5 mg/kg/d Bomedemstat and 200 mg/d Venetoclax;
* Dose Level 2: 3 mg/kg/d Bomedemstat and 200 mg/d Venetoclax;
* Dose Level 3: 3 mg/kg/d Bomedemstat and 400 mg/d Venetoclax.
Participants will receive three cycles of VenBom, but may continue to receive treatment as long as receiving clinical benefit or until disease progression. Participants starting at dose levels -2, -1, or 1 receive 100 mg Venetoclax on Cycle 1 Day 1. Receives: Drug: Bomedemstat; Drug: Venetoclax |
| Part 2: VenBom Expansion Cohort | Experimental | Participants in this group will receive VenBom therapy at the most appropriate dose determined in Part 1. Participants will continue to receive treatment as long as receiving clinical benefit or until disease progression. Receives: Drug: Bomedemstat; Drug: Venetoclax |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Toxicity
Toxicity is defined as including dose limiting toxicities (DLTs), serious adverse events (SAEs) and adverse events (AEs) in study participants. Toxicity will be assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, per physician discretion.
Measured: Up to 72 weeks
Recommended Phase 2 Dose (RP2D)
The RP2D of combination VenBom therapy will be determined as the maximum tolerated dose of study treatment as assessed by treating physician using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Measured: Up to 72 weeks
Secondary outcomes (2)
Overall Response Rate (ORR)
Rate of participants achieving complete response (CR), CR with incomplete neutrophil or platelet recovery (CRi), CR with incomplete hematologic recovery (CRh), partial remission (PR), or morphologic leukemia free state (MLFS) response to study treatment. Response will be assessed by treating physician using the modified 2017 European LeukemiaNet (ELN) AML Response Criteria.
Measured: Up to 72 weeks
Proportion of Participants with Measurable Residual Disease
Proportion of patients with measurable residual disease (MRD) evaluated by multiparameter flow cytometry (MFC) at each bone marrow aspirate collection.
Measured: Up to 72 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2022
- Study start19 Nov 2022
- Primary completion19 Nov 2026 (estimated)
- Study completion19 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Non-randomised
- Intervention model
- Sequential
- Model description
- Phase 1 dose escalation/de-escalation and dose expansion design.
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Terrence J Bradley, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Imago BioSciences, Inc., a subsidiary of Merck & Co., Inc., (Rahway, New Jersey USA)
- Responsible party
- Sponsor-investigator, Terrence J Bradley, MD, University of Miami
- Investigators
- Terrence J Bradley, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05597306
- Sponsor's protocol ID
- 20220733
- Other IDs
- NCI-2022-09456
- Acronym
- VenBom
- Status last verified
- Jan 2026
- First submitted
- 24 Oct 2022
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VenBom: A Phase 1 Study of Bomedemstat (IMG-7289), a Novel Inhibitor of Lysine-Specific Demethylase 1 (LSD1), in Combination With Venetoclax in Adult Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML)
- ClinicalTrials.gov ID
- NCT05597306
- Acronym / sponsor ID
- VenBom / 20220733
- Conditions
- Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia, Acute Myeloid Leukemia, in Relapse
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Terrence J Bradley, MDUniversity, hospital or other
- Collaborators
- Imago BioSciences, Inc., a subsidiary of Merck & Co., Inc., (Rahway, New Jersey USA)
- Study start
- 19 Nov 2022 (actual)
- Primary completion
- 19 Nov 2026 (estimated)
- Study completion
- 19 Nov 2026 (estimated)
- First posted
- 28 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Phase 1 dose escalation/de-escalation and dose expansion design.
| Arm | Type | Receives |
|---|---|---|
| Part 1: VenBom Dose Escalation/De-Escalation Cohort | Experimental | Drug: Bomedemstat, Drug: VenetoclaxParticipants in this group will receive Venetoclax and Bomedemstat (VenBom) in a dose escalation/de-escalation design to determine the maximum tolerated dose (MTD). Participants will receive VenBom for 21 days on (Days 1-21) and seven days off (Days 22-28) during a 28-day cycle for three months. Doses will be administered as follows: * Dose Level -2: 0.375 mg/kg daily (d) Bomedemstat and 200 mg/d Venetoclax; * Dose Level -1: 0.75 mg/kg/d Bomedemstat and 200 mg/d Venetoclax; * Dose Level 1 (Starting): 1.5 mg/kg/d Bomedemstat and 200 mg/d Venetoclax; * Dose Level 2: 3 mg/kg/d Bomedemstat and 200 mg/d Venetoclax; * Dose Level 3: 3 mg/kg/d Bomedemstat and 400 mg/d Venetoclax. Participants will receive three cycles of VenBom, but may continue to receive treatment as long as receiving clinical benefit or until disease progression. Participants starting at dose levels -2, -1, or 1 receive 100 mg Venetoclax on Cycle 1 Day 1. |
| Part 2: VenBom Expansion Cohort | Experimental | Drug: Bomedemstat, Drug: VenetoclaxParticipants in this group will receive VenBom therapy at the most appropriate dose determined in Part 1. Participants will continue to receive treatment as long as receiving clinical benefit or until disease progression. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Confirmed diagnosis of one of the following:
- 1. Relapsed/refractory Acute Myeloid Leukemia (AML) following failure of at least one standard, front-line therapy. Patients must have an AML diagnosis per the World Health Organization (WHO) criteria, regardless of etiology, sub-type or treatment history.
- Adult male or female patients 18 years of age or older.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2 (Appendix A: Performance Status Scales).
- Patients must satisfy the following laboratory criteria:
Key exclusion criteria (29 listed)
- Treatment with clinically significant metabolic enzyme inducers within 14 days before the first dose of the study drug. (Refer to Section 6.3 for instruction on use of strong or moderate Cytochrome P450 (CYP3A) inhibitors/inducers.)
- Diagnosis of acute promyelocytic leukemia (APL)
- Therapy with any investigational products, anti-neoplastic therapy, or radiotherapy within 14 days prior to Cycle 1, Day 1. Exception: Patients actively receiving hydroxyurea are eligible and may continue to receive hydroxyurea to control the level of circulating leukemic blast counts to not lower than 10,000 cells/μL during Cycle 1 of protocol treatment.
- Candidates for standard and/or potentially curative treatments (a candidate is defined as a patient that is both eligible and willing to have these treatments).
- Major surgery within 14 days before the first dose of study drug or a scheduled surgery during the study period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BomedemstatAlso: IMG-7289Bomedemstat will be administered orally once daily via capsule. | Drug | Part 1: VenBom Dose Escalation/De-Escalation Cohort, Part 2: VenBom Expansion Cohort |
| VenetoclaxAlso: VenclextaVenetoclax will be administered orally once daily via tablet. | Drug | Part 1: VenBom Dose Escalation/De-Escalation Cohort, Part 2: VenBom Expansion Cohort |
Primary outcome
Incidence of Treatment-Emergent Toxicity
Time frame: Up to 72 weeks
Toxicity is defined as including dose limiting toxicities (DLTs), serious adverse events (SAEs) and adverse events (AEs) in study participants. Toxicity will be assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, per physician discretion.
Recommended Phase 2 Dose (RP2D)
Time frame: Up to 72 weeks
The RP2D of combination VenBom therapy will be determined as the maximum tolerated dose of study treatment as assessed by treating physician using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
2 secondary outcomes
Overall Response Rate (ORR)
Time frame: Up to 72 weeks
Proportion of Participants with Measurable Residual Disease
Time frame: Up to 72 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Terrence J Bradley, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Bomedemstat and Venetoclax in people with Acute Myeloid Leukemia and Refractory Acute Myeloid Leukemia, run by Terrence J Bradley, MD 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 22 inclusion and 29 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 8 Jan 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 Alessia Zoso, PhD (305-243-2373, azoso@med.miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Toxicity (time frame: Up to 72 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jan 2026.