IMG-7289 in Patients With Essential Thrombocythemia (ET) or Polycythemia Vera (PV)

NCT04262141 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 20190932
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Essential Thrombocythemia; Polycythemia Vera

Outcome Measures

Primary Outcomes (1)

• Hematologic Response Rates

  As evaluated by the International Working Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT) and European Leukemia Net (ELN) response criteria.

  24 Weeks

Secondary Outcomes (5)

• Incidence of Treatment-Related Toxicity

  Up to 3 Years

• Change in Total Symptom Score (TSS) as Measured by the Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF)

  Baseline, Up to 3 Years

• Change in Mutational Allele Burden

  Baseline, Up to 3 Years

• Change in Spleen Size in Centimeters

  Baseline, Up to 3 Years

• Change in Fibrosis Score

  Baseline, Up to 3 Years

Study Arms (1)

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.

Drug: IMG-7289

Interventions

IMG-7289 DRUG

Daily oral dose of 0.6 mg/kg/day IMG-7829 capsules. Dose escalation an de-escalation rules applied as necessary.

Also known as: IMG7289, IMG 7289

IMG-7289 in ET and PV Patients

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 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.
• 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.

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Terrence J Bradley, MD: lead
• Imago BioSciences, Inc., a subsidiary of Merck & Co., Inc., (Rahway, New Jersey USA): collaborator

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Thrombocythemia, Essential; Polycythemia Vera

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; Bone Marrow Neoplasms; Hematologic Neoplasms; Neoplasms by Site; Neoplasms

Study Officials

• Terrence J Bradley, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 6, 2020
• First Posted: February 10, 2020
• Study Start: October 2, 2020
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2027
• Last Updated: January 7, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)