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

STATUS

Recruiting
participants needed

24
sponsor

Terrence J Bradley, MD

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Updated on 19 February 2024

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platelet count

fibrosis

neutrophil count

thrombocytopenia

myeloproliferative disorder

interferon

essential thrombocythemia

myelofibrosis

thrombocytosis

polycythemia vera

blast count

chronic myeloproliferative disease

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.

Details

Condition	ESSENTIAL THROMBOCYTHEMIA, Polycythemia Vera
Age	18-100 years
Treatment	IMG-7289
Clinical Study Identifier	NCT04262141
Sponsor	Terrence J Bradley, MD
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	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 > 450 x 10^9/L pre-dose Day 1
	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
Exclusion Criteria
	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
	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

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Study Definition

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