Hematology, IMG-7289, LSD1 (Lysine-Specific Demethylase 1) Inhibitor, Essential Thrombocythemia (ET), Ph 2

NCT04081220 | Active Not Recruiting Phase 2 Results FDA Drug

• 2 other identifiers: CTMS# 19-0078HSC20190791H
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Thrombocythemia, Essential

Outcome Measures

Primary Outcomes (1)

• The Proportion of Patients Who Achieve Complete Hematologic Remission at Week 24 Using ELN Response Criteria for ET (Barosi et al., 2013)

  ELN criteria

  24 weeks

Secondary Outcomes (1)

• Additional Therapy Period (ATP) Overall Symptom Burden

  24 weeks to 48 weeks (may repeat)

Study Arms (1)

IMG-7289

EXPERIMENTAL

Drug: IMG-7289

Interventions

IMG-7289 DRUG

Single starting dose with individualized dose titrations throughout

Also known as: LSD1 inhibitor

IMG-7289

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years.
• Diagnosis of Essential Thrombocythemia per World Health Organization (WHO) diagnostic criteria for myeloproliferative neoplasms (Arber et al., 2016).
• \. 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;
• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead
• Imago BioSciences, Inc., a subsidiary of Merck & Co., Inc., (Rahway, New Jersey USA): collaborator

Study Sites (1)

Mays Cancer Center

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Thrombocythemia, Essential

Interventions

bomedemstat

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombocytosis; Blood Platelet Disorders; Myeloproliferative Disorders; Bone Marrow Diseases; Hemorrhagic Disorders

Results Point of Contact

• Title: Dr Zohra Nooruddin
• Organization: UT HEALTH MAYS CANCER CENTER

nooruddinz@uthscsa.edu

2013362409

Study Officials

• Zohra Nooruddin, MD

  Mays Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2019
• First Posted: September 9, 2019
• Study Start: April 9, 2020
• Primary Completion: December 20, 2023
• Study Completion (Estimated): December 20, 2026
• Last Updated: September 10, 2025
• Results First Posted: May 20, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)