Essential ThrombocythemiaPhase 2NCT04262141
IMG-7289 in Patients With Essential Thrombocythemia (ET) or Polycythemia Vera (PV)
A Phase 2 study testing IMG-7289 in people with Essential Thrombocythemia and Polycythemia Vera, run by Terrence J Bradley, MD at 1 site in United States.
Trial summary
The purpose of this study is to assess the hematologic effects of IMG-7289 therapy in ET and PV patients who require platelet, White Blood Cell (WBC) or Red Blood Cell (RBC) control, and have failed at least one standard therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Essential Thrombocythemia, Polycythemia Vera
- What is being tested?
- IMG-7289
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Oct 2020to 31 Oct 2027
- Phase
- Phase 2
- 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
- Age ≥ 18 years.
- Diagnosis of Essential Thrombocythemia or Polycythemia Vera per World Health Organization (WHO) diagnostic criteria for myeloproliferative neoplasms (Arber et al., 2016).
- Patients that have failed at least one standard therapy (failure is the equivalent of inadequate response or intolerance).
- Platelet count >400 x 10^9/L pre-dose Day 1for patients with essential thrombocytopenia.
- Platelet count >150 x 10^9/L pre-dose Day 1 for patients with polycythemia vera.
- Peripheral blast count < 10% pre-dose Day 1.
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- Absolute neutrophil count (ANC) ≥ 0.5 x 10^9/L pre-dose Day 1.
- Fibrosis score ≤ grade 2, as per a slightly modified version (Arber et al., 2016) of the European Consensus Criteria for Grading Myelofibrosis, (Thiele et al., 2005).
- Life expectancy > 36 weeks.
- Able to swallow capsules.
- Amenable to blood draws, spleen size determination, bone marrow evaluations, and peripheral blood sampling during the study.
- Must have discontinued prior therapy for condition under study for 2 weeks (4 weeks for interferon) prior to study drug initiation.
- Agrees to use an approved method of contraception from Screening until 28 days after last administration of the study drug.
- If male, agrees not to donate sperm or father a child for at least one month after the last dose of the study medication.
Who cannot join
- Eastern Cooperative Oncology Group (ECOG) questionnaire score of 3 or greater.
- Currently pregnant, planning on being pregnant in the following 6 months or currently breastfeeding.
- Currently residing outside the United States.
- History of splenectomy.
- Unresolved treatment related toxicities from prior therapies (unless resolved to ≤ Grade 1).
- Uncontrolled active infection.
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- Known positive for HIV if not well-controlled (i.e., undetectable viral load), or infectious hepatitis, type A, B or C.
- Current use of monoamine oxidase A and B inhibitors (MAOIs).
- Evidence at the time of screening of increased risk of bleeding, including any of the following:
- Activated partial thromboplastin time (aPTT) > 1.3 x the upper limit of normal
- International normalized ratio (INR) >1.3 x the local upper limit of normal
- History of severe thrombocytopenia or platelet dysfunction unrelated to a myeloproliferative disorder or its treatment
- Known bleeding disorder (e.g., dysfibrinogenaemia, factor IX deficiency, haemophilia, Von Willebrand's disorder, Disseminated Intravascular Coagulation [DIC], fibrinogen deficiency, or other clotting factor deficiency)
- Evidence at the time of Screening of significant renal or hepatic insufficiency (unless due to haemolysis, or leukaemic infiltration) 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 x the local upper limit of normal
- Current use of a prohibited medication (e.g., romiplostim) or expected to require any of these medications during treatment with the investigational drug.
- Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to IMG-7289 or LSD1 inhibitors (i.e., monoamine oxidase inhibitors; MAOIs) that contraindicates their participation.
- Patients with impaired decision-making capacity.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigator-Initiated Trial of the LSD1 Inhibitor IMG-7289 for the Treatment of Patients With Essential Thrombocythemia (ET) or Polycythemia Vera (PV) That Have Failed at Least One Standard Therapy
The purpose of this study is to assess the hematologic effects of IMG-7289 therapy in ET and PV patients who require platelet, White Blood Cell (WBC) or Red Blood Cell (RBC) control, and have failed at least one standard therapy.
- Conditions
- Essential Thrombocythemia, Polycythemia Vera
- Being tested
- IMG-7289
- Medical subject headings
- Thrombocythemia, Essential, Polycythemia Vera
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMG-7289Drug
Also called IMG7289, IMG 7289
Daily oral dose of 0.6 mg/kg/day IMG-7829 capsules. Dose escalation an de-escalation rules applied as necessary.
| Study group | Role | What they receive |
|---|---|---|
| IMG-7289 in ET and PV Patients | Experimental | Oral daily dose of 0.6 mg/kg/day IMG-7289 will be administered:
* The initial pilot period will enroll 8 participants to receive oral daily dose of IMG-7829 for 24 weeks, iteratively as long as there is clinical benefit in the absence of excess toxicity.
* The second stage group will enroll an additional 16 participants to receive IMG-7829 for over 2 years, iteratively as long as there is clinical benefit in the absence of toxicity. Receives: Drug: IMG-7289 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hematologic Response Rates
As evaluated by the International Working Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT) and European Leukemia Net (ELN) response criteria.
Measured: 24 Weeks
Secondary outcomes (5)
Incidence of Treatment-Related Toxicity
As evaluated by the treating physician using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0.
Measured: Up to 3 Years
Change in Total Symptom Score (TSS) as Measured by the Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF)
As measured using the Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF) that includes 14 disease related symptoms each scored from 0 (absent) to 10 (worst imaginable).
Measured: Baseline, Up to 3 Years
Change in Mutational Allele Burden
Evaluated via Next Generation Sequencing (NGS) molecular profiling from serum blood sample.
Measured: Baseline, Up to 3 Years
Change in Spleen Size in Centimeters
Measured via physical examination and radiologic imaging measurement.
Measured: Baseline, Up to 3 Years
Change in Fibrosis Score
Assessed using a slightly modified version of European Consensus Criteria for Grading Myelofibrosis from bone marrow/aspirate sample, as presented in Thiele et al, 2005. Myelofibrosis (MF) scores are graded on a four-point scale, from MF-0 to MF-3, grading the reticulin and collagen content of bone marrow, with MF-0 being the lowest and MF-3 the highest.
Measured: Baseline, Up to 3 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2020
- Study start2 Oct 2020
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Essential ThrombocythemiaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
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
- NCT04262141
- Sponsor's protocol ID
- 20190932
- Status last verified
- Jan 2026
- First submitted
- 6 Feb 2020
- Last updated
- 7 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 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigator-Initiated Trial of the LSD1 Inhibitor IMG-7289 for the Treatment of Patients With Essential Thrombocythemia (ET) or Polycythemia Vera (PV) That Have Failed at Least One Standard Therapy
- ClinicalTrials.gov ID
- NCT04262141
- Acronym / sponsor ID
- 20190932
- Conditions
- Essential Thrombocythemia, Polycythemia Vera
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 4 participants (actual)
- 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
- 2 Oct 2020 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 10 Feb 2020 (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.
The purpose of this study is to assess the hematologic effects of IMG-7289 therapy in ET and PV patients who require platelet, White Blood Cell (WBC) or Red Blood Cell (RBC) control, and have failed at least one standard therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IMG-7289 in ET and PV Patients | Experimental | Drug: IMG-7289Oral daily dose of 0.6 mg/kg/day IMG-7289 will be administered: * The initial pilot period will enroll 8 participants to receive oral daily dose of IMG-7829 for 24 weeks, iteratively as long as there is clinical benefit in the absence of excess toxicity. * The second stage group will enroll an additional 16 participants to receive IMG-7829 for over 2 years, iteratively as long as there is clinical benefit in the absence of toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Age ≥ 18 years.
- Diagnosis of Essential Thrombocythemia or Polycythemia Vera per World Health Organization (WHO) diagnostic criteria for myeloproliferative neoplasms (Arber et al., 2016).
- Patients that have failed at least one standard therapy (failure is the equivalent of inadequate response or intolerance).
- Platelet count >400 x 10^9/L pre-dose Day 1for patients with essential thrombocytopenia.
- Platelet count >150 x 10^9/L pre-dose Day 1 for patients with polycythemia vera.
Key exclusion criteria (19 listed)
- Eastern Cooperative Oncology Group (ECOG) questionnaire score of 3 or greater.
- Currently pregnant, planning on being pregnant in the following 6 months or currently breastfeeding.
- Currently residing outside the United States.
- History of splenectomy.
- Unresolved treatment related toxicities from prior therapies (unless resolved to ≤ Grade 1).
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 |
|---|---|---|
| IMG-7289Also: IMG7289, IMG 7289Daily oral dose of 0.6 mg/kg/day IMG-7829 capsules. Dose escalation an de-escalation rules applied as necessary. | Drug | IMG-7289 in ET and PV Patients |
Primary outcome
Hematologic Response Rates
Time frame: 24 Weeks
As evaluated by the International Working Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT) and European Leukemia Net (ELN) response criteria.
5 secondary outcomes
Incidence of Treatment-Related Toxicity
Time frame: Up to 3 Years
Change in Total Symptom Score (TSS) as Measured by the Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF)
Time frame: Baseline, Up to 3 Years
Change in Mutational Allele Burden
Time frame: Baseline, Up to 3 Years
Change in Spleen Size in Centimeters
Time frame: Baseline, Up to 3 Years
Change in Fibrosis Score
Time frame: Baseline, Up to 3 Years
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 7 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. This study is not recruiting at the moment.
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 2 study testing IMG-7289 in people with Essential Thrombocythemia and Polycythemia Vera, 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 14 inclusion and 19 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: under way, not looking for participants, as of the sponsor's last update on 7 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 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?
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hematologic Response Rates (time frame: 24 Weeks). 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 7 Jan 2026.