MyelofibrosisPhase 2NCT05569538
Bomedemstat (IMG-7289) Plus Ruxolitinib for Myelofibrosis
A Phase 2 study testing Bomedemstat in people with Myelofibrosis, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
This is an open-label, Phase 2 study of bomedemstat (IMG-7289), an inhibitor of lysine-specific demethylase 1 (LSD1), in combination with JAK inhibition (JAKi) in patients with myelofibrosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myelofibrosis
- What is being tested?
- Bomedemstat
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Dec 2022to 31 Dec 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Cohort A:
- 1. Patients refractory to, relapsed or intolerant of ruxolitinib as per one of the below:
- Refractory is defined as <30% reduction in spleen length or <10% SVR compared to baseline having received ruxolitinib for ≥12 weeks prior to enrollment, AND on a stable dose for ≥8 weeks prior to starting investigational therapy
- Relapsed is defined as an increase in spleen volume of ≥25% by MRI/CT from nadir, or, ≥100% in palpable spleen length from a baseline of 5 to 10 cm BLCM or, ≥50% increase in spleen length from a baseline spleen length ≥10 cm BLCM
- Intolerance is defined as the development in patients treated with ruxolitinib for ≥28 days of:
- Red blood cell transfusion requirement of 2 units/month for 2 months
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- Grade 3 thrombocytopenia, anemia, hematoma, and/or hemorrhage while on ruxolitinib treatment
- Cohort B:
- Patients who are JAK inhibitor naïve, AND:
- Require MF-directed treatment, AND
- Have measurable disease burden including one of the following:
- Disease-related symptoms, determined by a MFSAF or MPN-SAF TSS of ≥10, or at least 2 symptoms with scores ≥3
- Documented splenomegaly by physical exam, with spleen palpated ≥5 cm below the left costal margin
- Both Cohorts A and B:
- Willing and able to provide informed consent
- Age ≥18 years
- Diagnosis of Overt Myelofibrosis (primary, post-ET, or post-PV) per World Health Organization (WHO) diagnostic criteria
- Intermediate-1, Intermediate-2, or high-risk disease by Dynamic International Prognostic Scoring System (DIPSS)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Platelet count ≥100 x 10^9/L prior to dosing on Cycle 1 Day 1
- Absolute neutrophil count ≥0.5 x 10^9/L prior to dosing on Cycle 1 Day 1
- Peripheral blast count ≤10% prior to dosing on Cycle 1 Day 1
- Able to swallow capsules
- Women of childbearing potential and fertile men must agree to use an approved method of contraception from Screening until 30 days after the last dose of bomedemstat and ruxolitinib.
Who cannot join
- Those with increased risk of bleeding, including any of the following:
- Activated partial thromboplastin time (aPTT) ≥1.3 x the local upper limit of normal
- International normalized ratio (INR) ≥1.3 x the local upper limit of normal
- Known history of a platelet function disorder
- Other known bleeding disorder that is active at the time of screening (Von Willebrand's disease, dysfibrinogenemia, hemophilia, etc.)
- History of splenectomy or prior splenic irradiation
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- Use of an investigational agent within 14 days of study treatment (or at least 7 half-lives of that agent, whichever is longer), prior to the first dose of bomedemstat
- Current use of monoamine oxidase A and B inhibitors (MAOIs)
- Uncontrolled, active infection
- Major surgery within 4 weeks of starting the study drug, or not recovered from side effects of surgery
- Any other serious medical conditions that could compromise study participation, in the opinion of the investigator
- Known HIV infection or known, active hepatitis B or hepatitis C infection
- Concurrent second active and non-stable malignancy (patients with a concurrent second active but stable malignancy, i.e., non-melanoma skin cancers, are eligible)
- Current use of a prohibited medication (e.g., romiplostim) or expected to require any of these medications during treatment
- Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to bomedemstat or LSD1 inhibitors (i.e., monoamine oxidase inhibitors; MAOIs) that contraindicates participation
- Evidence at the time of Screening of significant renal or hepatic insufficiency (unless due to hemolysis) as defined by any of the following local lab parameters:
- Calculated glomerular filtration rate (GFR; using the Cockcroft-Gault equation) <40 mL/min or serum creatinine >1.5 x the local upper limit of normal
- Aspartate transaminase (AST) or alanine aminotransferase (ALT) ≥2.5 x the local upper limit of normal
- Pregnant or lactating females, or females planning to become pregnant at any time during the study
- Unwilling or unable to comply with the study protocol
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Department of Medicine, the University of Hong Kong, Queen Mary Hospital
Hong Kong
Harinder Singh Harry Gill, MD, +852 22554254, gillhsh@hku.hk
About this study
Official title: Phase 2 Study to Assess the Safety and Efficacy of Bomedemstat (IMG-7289) in Combination With Ruxolitinib in Patients With Myelofibrosis
This is an open-label, Phase 2 study of bomedemstat (IMG-7289), an inhibitor of lysine-specific demethylase 1 (LSD1), in combination with JAK inhibition (JAKi) in patients with myelofibrosis.
- Conditions
- Myelofibrosis
- Being tested
- Bomedemstat
- Keywords
- Myelofibrosis, Bomedemstat, Ruxolitinib
- Medical subject headings
- Primary Myelofibrosis
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 self-administered orally once daily. In both cohorts, the dose of bomedemstat will be adjusted in each patient based on titration of the patient's platelet count to the target range. Ruxolitinib will be self-administered orally. Both medications will continue uninterrupted in 28-day cycles. Subjects will continue combination treatment through the Initial Treatment Period (first 6 cycles), which includes a Qualification Assessment. Those deriving clinical benefit in the opinion of the treating physician may continue receiving combination treatment in the Additional Treatment Period (6 cycles). Qualification Assessments will be performed at the end of each Additional Treatment Period, which is iterative, and may repeat for as long as clinical benefit is sustained, at the discretion of the treating physician.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A (Patients refractory to, relapsed or intolerant of ruxolitinib): | Experimental | Bomedemstat : The starting dose of bomedemstat at Initial Treatment Period Cycle 1 Day 1 will be 0.4 mg/kg daily for all patients in Cohort A. The first up-titration is not permitted until Initial Treatment Period Cycle 2 Day 1; thereafter, the dose may be up-titrated no more frequently than every 4 weeks from the prior up- or down-titration (note: down-titrations may occur at any time (or the current dose maintained) in the best interest and safety of the patient), to a target platelet count range of 50-100 x 10^9/L.
Ruxolitinib: Patients will continue their prior, stable dose of ruxolitinib. This same dose will be continued throughout the study unless dose modification is required because of toxicity. Receives: Drug: Bomedemstat |
| Cohort B (Cohort B will consist of 10 patients who are JAK inhibitor naïve): | Experimental | Bomedemstat: The starting dose of bomedemstat at Initial Treatment Period Cycle 1 Day 1 will be 0.4 mg/kg daily for all patients in Cohort B. The first up-titration is not permitted until Initial Treatment Period Cycle 2 Day 1; thereafter, the dose may be up-titrated no more frequently than every 4 weeks from the prior up- or down-titration (note: down-titrations may occur at any time (or the current dose maintained) in the best interest and safety of the patient), to a target platelet count range of 50-100 x 10^9/L.
Ruxolitinib: Patients will start treatment with ruxolitinib at Initial Treatment Period Cycle 1 Day 1. The starting dose of ruxolitinib will be 10 mg BID. This same dose will be continued throughout the study unless dose modification is required because of toxicity. Receives: Drug: Bomedemstat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Enumeration and description of adverse events (AEs), including determination of dose limiting toxicities (DLTs), serious adverse events (SAEs), and other AEs
Measured: 24 months
Secondary outcomes (2)
Spleen response at 24 weeks
Proportion of patients who experience a spleen length reduction by palpation of ≥30% OR spleen volume reduction (SVR) of ≥35% by MRI or CT by 24 weeks of treatment
Measured: 24 weeks
Symptom response at 24 weeks
Proportion of patients who describe a ≥50% reduction in symptom burden by the Myelofibrosis Symptom Assessment Form (MFSAF) by 24 weeks of treatment
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2022
- Study start1 Dec 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MyelofibrosisStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Imago BioSciences, Inc., a subsidiary of Merck & Co., Inc., (Rahway, New Jersey USA)
- Responsible party
- Sponsor
- Investigators
- Harinder Gill, MD, Principal investigator, Department of Medicine, the University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05569538
- Sponsor's protocol ID
- IMG-7289-IIS001
- Status last verified
- Oct 2022
- First submitted
- 3 Oct 2022
- Last updated
- 23 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gill H, Palandri F, Ross DM, Gothert JR, Cochrane T, Larsen SR, Halpern AB, Shortt J, Rossetti JM, Liang J, Marchetti M, Wilson AJ, Innes AJ, Hanna M, Vianelli N, Stevenson WS, Vannucchi AM, Kleppe M, Flynn J, Natsoulis G, Harrison CN, Rienhoff HY Jr. Phase 2 study of the lysine-specific demethylase 1 inhibitor bomedemstat for essential thrombocythemia. Blood Adv. 2026 May 26;10(10):3494-3504. doi: 10.1182/bloodadvances.2025017575.
PubMed 41758981
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study to Assess the Safety and Efficacy of Bomedemstat (IMG-7289) in Combination With Ruxolitinib in Patients With Myelofibrosis
- ClinicalTrials.gov ID
- NCT05569538
- Acronym / sponsor ID
- IMG-7289-IIS001
- Conditions
- Myelofibrosis
- Keywords
- Myelofibrosis, Bomedemstat, Ruxolitinib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Imago BioSciences, Inc., a subsidiary of Merck & Co., Inc., (Rahway, New Jersey USA)
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 6 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 is an open-label, Phase 2 study of bomedemstat (IMG-7289), an inhibitor of lysine-specific demethylase 1 (LSD1), in combination with JAK inhibition (JAKi) in patients with myelofibrosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A (Patients refractory to, relapsed or intolerant of ruxolitinib): | Experimental | Drug: BomedemstatBomedemstat : The starting dose of bomedemstat at Initial Treatment Period Cycle 1 Day 1 will be 0.4 mg/kg daily for all patients in Cohort A. The first up-titration is not permitted until Initial Treatment Period Cycle 2 Day 1; thereafter, the dose may be up-titrated no more frequently than every 4 weeks from the prior up- or down-titration (note: down-titrations may occur at any time (or the current dose maintained) in the best interest and safety of the patient), to a target platelet count range of 50-100 x 10^9/L. Ruxolitinib: Patients will continue their prior, stable dose of ruxolitinib. This same dose will be continued throughout the study unless dose modification is required because of toxicity. |
| Cohort B (Cohort B will consist of 10 patients who are JAK inhibitor naïve): | Experimental | Drug: BomedemstatBomedemstat: The starting dose of bomedemstat at Initial Treatment Period Cycle 1 Day 1 will be 0.4 mg/kg daily for all patients in Cohort B. The first up-titration is not permitted until Initial Treatment Period Cycle 2 Day 1; thereafter, the dose may be up-titrated no more frequently than every 4 weeks from the prior up- or down-titration (note: down-titrations may occur at any time (or the current dose maintained) in the best interest and safety of the patient), to a target platelet count range of 50-100 x 10^9/L. Ruxolitinib: Patients will start treatment with ruxolitinib at Initial Treatment Period Cycle 1 Day 1. The starting dose of ruxolitinib will be 10 mg BID. This same dose will be continued throughout the study unless dose modification is required because of toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- 1. Patients refractory to, relapsed or intolerant of ruxolitinib as per one of the below:
- Refractory is defined as <30% reduction in spleen length or <10% SVR compared to baseline having received ruxolitinib for ≥12 weeks prior to enrollment, AND on a stable dose for ≥8 weeks prior to starting investigational therapy
- Relapsed is defined as an increase in spleen volume of ≥25% by MRI/CT from nadir, or, ≥100% in palpable spleen length from a baseline of 5 to 10 cm BLCM or, ≥50% increase in spleen length from a baseline spleen length ≥10 cm BLCM
- Intolerance is defined as the development in patients treated with ruxolitinib for ≥28 days of:
- Patients who are JAK inhibitor naïve, AND:
Key exclusion criteria (20 listed)
- Those with increased risk of bleeding, including any of the following:
- History of splenectomy or prior splenic irradiation
- Use of an investigational agent within 14 days of study treatment (or at least 7 half-lives of that agent, whichever is longer), prior to the first dose of bomedemstat
- Current use of monoamine oxidase A and B inhibitors (MAOIs)
- Uncontrolled, active infection
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 self-administered orally once daily. In both cohorts, the dose of bomedemstat will be adjusted in each patient based on titration of the patient's platelet count to the target range. Ruxolitinib will be self-administered orally. Both medications will continue uninterrupted in 28-day cycles. Subjects will continue combination treatment through the Initial Treatment Period (first 6 cycles), which includes a Qualification Assessment. Those deriving clinical benefit in the opinion of the treating physician may continue receiving combination treatment in the Additional Treatment Period (6 cycles). Qualification Assessments will be performed at the end of each Additional Treatment Period, which is iterative, and may repeat for as long as clinical benefit is sustained, at the discretion of the treating physician. | Drug | Cohort A (Patients refractory to, relapsed or intolerant of ruxolitinib):, Cohort B (Cohort B will consist of 10 patients who are JAK inhibitor naïve): |
Primary outcome
Adverse events
Time frame: 24 months
Enumeration and description of adverse events (AEs), including determination of dose limiting toxicities (DLTs), serious adverse events (SAEs), and other AEs
2 secondary outcomes
Spleen response at 24 weeks
Time frame: 24 weeks
Symptom response at 24 weeks
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2023.
- Derived from this study: PubMed 41758981Gill H, Palandri F, Ross DM, Gothert JR, Cochrane T, Larsen SR, Halpern AB, Shortt J, Rossetti JM, Liang J, Marchetti M, Wilson AJ, Innes AJ, Hanna M, Vianelli N, Stevenson WS, Vannucchi AM, Kleppe M, Flynn J, Natsoulis G, Harrison CN, Rienhoff HY Jr. Phase 2 study of the lysine-specific demethylase 1 inhibitor bomedemstat for essential thrombocythemia. Blood Adv. 2026 May 26;10(10):3494-3504. doi: 10.1182/bloodadvances.2025017575.
- 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. This study is not recruiting at the moment.
Harinder Gill, MD principal investigator
Department of Medicine, the University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bomedemstat in people with Myelofibrosis, run by The University of Hong Kong at 1 site in Hong Kong.
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 24 inclusion and 20 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: status not confirmed, as of the sponsor's last update on 23 May 2023. 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 Hong Kong. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Harinder Gill, MD (+852 22554542, gillhsh@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (time frame: 24 months). 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 NCT05569538, which also lists 1 linked publication.
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 23 May 2023.