Thrombocythemia, EssentialPhase 2NCT04081220
Hematology, IMG-7289, LSD1 (Lysine-Specific Demethylase 1) Inhibitor, Essential Thrombocythemia (ET), Ph 2
A Phase 2 study testing IMG-7289 in people with Thrombocythemia, Essential, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial summary
This is a single-center, open-label investigator-initiated trial evaluating the effects of IMG-7289 administered orally once daily in patients with essential thrombocythemia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thrombocythemia, Essential
- What is being tested?
- IMG-7289
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Apr 2020to 20 Dec 2026
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 per World Health Organization (WHO) diagnostic criteria for myeloproliferative neoplasms (Arber et al., 2016).
- 3. Patients who are intolerant or resistant to hydroxyurea per ELN (European Leukemia Net) criteria, or in the Investigator's judgment are not candidates for available approved therapy. The ELN definitions of resistance/intolerance to HU (hydroxyurea) requires the fulfillment of at least one of the following criteria:
- Platelet count greater than 600 × 109/L after 3 months of at least 2 g/day of HU (2.5 g/day in patients with a body weight over 80 kg);
- Platelet count greater than 400 × 109/L and leukocytes less than 2.5 × 109/L or hemoglobin (Hb) less than 100 g/L at any dose of HU;
- Presence of leg ulcers or other unacceptable mucocutaneous manifestations at any dose of HU;
Show all 18Show fewer
- HU-related fever.
- Requires treatment in order to lower platelet counts based on the Clinically Relevant IPSET (International Prognostic Score for Thrombosis in Essential Thrombocythemia) -Thrombosis Guidelines.
- Platelet count >450 x 109/L pre-dose Day 1.
- Peripheral blast count <10% pre-dose Day 1.
- ANC (absolute neutrophil count) ≥0.5 x 109/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 spleen size determination, bone marrow evaluations, and peripheral blood sampling during the study.
- Must have discontinued ET therapy at least 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. Acceptable methods of birth control include: birth control pills, depo-progesterone injections, a vaginal hormonal contraceptive ring, a barrier contraceptive such as a condom with spermicide cream or gel, diaphragms or cervical cap with spermicide cream or gel, or an intrauterine device (IUD).
- 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
- Greater than 3 separate transfusion episodes over the last 6 months and/or any transfusion over the last 4 weeks.
- Eastern Cooperative Oncology Group (ECOG) questionnaire score of 3 or greater.
- Currently pregnant or 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).
Show all 13Show fewer
- Uncontrolled active infection.
- Known positive for HIV 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
- Known Acquired Von Willebrand's disorder.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Investigator Initiated Phase 2 Trial of the LSD1 Inhibitor IMG-7289 in Essential Thrombocythemia (CTMS# 19-0078)
This is a single-center, open-label investigator-initiated trial evaluating the effects of IMG-7289 administered orally once daily in patients with essential thrombocythemia.
- Conditions
- Thrombocythemia, Essential
- Being tested
- IMG-7289
- Medical subject headings
- Thrombocythemia, Essential
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMG-7289Drug
Also called LSD1 inhibitor
Single starting dose with individualized dose titrations throughout
| Study group | Role | What they receive |
|---|---|---|
| IMG-7289 | Experimental | Not described Receives: Drug: IMG-7289 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Proportion of Patients Who Achieve Complete Hematologic Remission at Week 24 Using ELN Response Criteria for ET (Barosi et al., 2013)
ELN criteria
Measured: 24 weeks
Secondary outcomes (1)
Additional Therapy Period (ATP) Overall Symptom Burden
Symptom Forms will be completed by participants each week of participation in the study- even on weeks with no study visit. Symptom Form are completed at around the same time on each of the following days: Day 1, Day 8, Day 15, Day 22, Day 29, Day 36, Day 43, Day 50, Day 57, Day 64, Day 71, Day 78, Day 85, Day 92, Day 99, Day 106, Day 113, Day 120, Day 127, Day 134, Day 141, Day 148, Day 155, Day 162 and Day 169.
Measured: 24 weeks to 48 weeks (may repeat)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2019
- Study start9 Apr 2020
- Primary completion20 Dec 2023
- Study completion20 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Thrombocythemia, EssentialStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Imago BioSciences, Inc., a subsidiary of Merck & Co., Inc., (Rahway, New Jersey USA)
- Responsible party
- Sponsor
- Investigators
- Zohra Nooruddin, MD, Principal investigator, Mays Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04081220
- Sponsor's protocol ID
- CTMS# 19-0078
- Other IDs
- HSC20190791H
- Status last verified
- Oct 2026
- First submitted
- 4 Sep 2019
- Last updated
- 22 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- 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 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigator Initiated Phase 2 Trial of the LSD1 Inhibitor IMG-7289 in Essential Thrombocythemia (CTMS# 19-0078)
- ClinicalTrials.gov ID
- NCT04081220
- Acronym / sponsor ID
- CTMS# 19-0078
- Conditions
- Thrombocythemia, Essential
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 9 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Collaborators
- Imago BioSciences, Inc., a subsidiary of Merck & Co., Inc., (Rahway, New Jersey USA)
- Study start
- 9 Apr 2020 (actual)
- Primary completion
- 20 Dec 2023 (actual)
- Study completion
- 20 Dec 2026 (estimated)
- First posted
- 9 Sep 2019 (actual)
- Results
- Posted 20 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single-center, open-label investigator-initiated trial evaluating the effects of IMG-7289 administered orally once daily in patients with essential thrombocythemia.
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 | Experimental | Drug: IMG-7289 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Age ≥18 years.
- Diagnosis of Essential Thrombocythemia per World Health Organization (WHO) diagnostic criteria for myeloproliferative neoplasms (Arber et al., 2016).
- 3. Patients who are intolerant or resistant to hydroxyurea per ELN (European Leukemia Net) criteria, or in the Investigator's judgment are not candidates for available approved therapy. The ELN definitions of resistance/intolerance to HU (hydroxyurea) requires the fulfillment of at least one of the following criteria:
- Requires treatment in order to lower platelet counts based on the Clinically Relevant IPSET (International Prognostic Score for Thrombosis in Essential Thrombocythemia) -Thrombosis Guidelines.
- Platelet count >450 x 109/L pre-dose Day 1.
Key exclusion criteria (13 listed)
- Greater than 3 separate transfusion episodes over the last 6 months and/or any transfusion over the last 4 weeks.
- Eastern Cooperative Oncology Group (ECOG) questionnaire score of 3 or greater.
- Currently pregnant or planning on being pregnant in the following 6 months or currently breastfeeding.
- Currently residing outside the United States.
- History of splenectomy.
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: LSD1 inhibitorSingle starting dose with individualized dose titrations throughout | Drug | IMG-7289 |
Primary outcome
The Proportion of Patients Who Achieve Complete Hematologic Remission at Week 24 Using ELN Response Criteria for ET (Barosi et al., 2013)
Time frame: 24 weeks
ELN criteria
1 secondary outcome
Additional Therapy Period (ATP) Overall Symptom Burden
Time frame: 24 weeks to 48 weeks (may repeat)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Thrombocythemia, Essential
RecruitingPhase 3
A Phase 3 Study of Pelabresib (DAK539) and Ruxolitinib in Myelofibrosis (MF)
Primary Myelofibrosis (PMF), Post-polycythemia Vera Myelofibrosis (PPV-MF)
RecruitingPhase 3
A Phase 3 Study of INCA033989 Versus Best Available Therapy in Participants With Essential Thrombocythemia
Essential Thrombocythemia
RecruitingPhase 2
Study of Momelotinib in Combination With Luspatercept in Participants With Transfusion Dependent Myelofibrosis
Primary Myelofibrosis, Myelofibrosis; Primary Myelofibrosis; Post-polycythemia Vera Myelofibrosis; Post-essential Thrombocythemia Myelofibrosis
RecruitingPhase 1
Study of INCA036978 in Participants With Myeloproliferative Neoplasms
Myeloproliferative Neoplasms
Recruiting
Functional and Phenotypic Characterization of Monocytes in Myeloproliferative Syndromes
Myeloproliferative Neoplasm, Polycythemia Vera
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.
Zohra Nooruddin, MD principal investigator
Mays Cancer Center
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 Thrombocythemia, Essential, run by The University of Texas Health Science Center at San Antonio 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 18 inclusion and 13 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 22 Oct 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?
Yes. Results are posted in the registry (first posted 20 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Proportion of Patients Who Achieve Complete Hematologic Remission at Week 24 Using ELN Response Criteria for ET (Barosi et al., 2013) (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 22 Oct 2026.