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Clinical Trials List

Protocol NumberMK-3543-006
NCT Number(ClinicalTrials.gov Identfier)NCT06079879
Active

2023-11-01 - 2031-12-31

Phase III

Recruiting5

ICD-10C88.8

Other malignant immunoproliferative diseases

ICD-10C94.40

Acute panmyelosis with myelofibrosis not having achieved remission

ICD-10C94.41

Acute panmyelosis with myelofibrosis, in remission

ICD-10C94.42

Acute panmyelosis with myelofibrosis, in relapse

ICD-10C94.6

Myelodysplastic disease, not classified

ICD-10D46.9

Myelodysplastic syndrome, unspecified

ICD-10D46.A

Refractory cytopenia with multilineage dysplasia

ICD-10D46.B

Refractory cytopenia with multilineage dysplasia and ring sideroblasts

ICD-10D46.C

Myelodysplastic syndrome with isolated del(5q) chromosomal abnormality

ICD-10D46.Z

Other myelodysplastic syndromes

ICD-10D47.1

Chronic myeloproliferative disease

ICD-10D47.3

Essential (hemorrhagic) thrombocythemia

ICD-10D47.9

Neoplasm of uncertain behavior of lymphoid, hematopoietic and related tissue, unspecified

ICD-10D47.Z1

Post-transplant lymphoproliferative disorder (PTLD)

ICD-10D47.Z9

Other specified neoplasms of uncertain behavior of lymphoid, hematopoietic and related tissue

ICD-9238.7

Neoplasm of uncertain behavior of other lymphatic and hematopoietic tissues

A Phase 3, Randomized, Open-label, Active-Comparator-Controlled Clinical Study to Evaluate the Safety and Efficacy of Bomedemstat (MK-3543/IMG-7289) Versus Best Available Therapy (BAT) in Participants With Essential Thrombocythemia Who Have an Inadequate Response to or Are Intolerant of Hydroxyurea

  • Trial Applicant

    Merck Sharp & Dohme (I.A.) LLC

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/06/23

Investigators and Locations

Principal Investigator HSUAN JEN SHIH Division of Hematology & Oncology
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 廖碧涵 Division of Hematology & Oncology
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator
Chiayi Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator HSIN-AN HOU 無
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Tsai-Yun Chen
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Essential Thrombocythemia

Objectives

Primary Objectives: (1) To compare the durable clinical-hematological response (DCHR) between bomedemstat and best existing therapy. Secondary Objectives: (1) To compare changes in fatigue scores between bomedemstat and best existing therapy according to the Myelofibrosis Symptom Assessment Scale version 4.0 (MFSAF v4.0). (2) To compare changes in total fatigue scores between bomedemstat and best existing therapy according to the Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form 7a (SF-7a). (3) To compare changes in total symptom scores between bomedemstat and best existing therapy according to MFSAF v4.0. (4) To assess the duration of clinical-hematological response (DOCHR) between the two treatment groups. (5) To assess the duration of hematological remission (DOHR) between the two treatment groups. (6) To assess the incidence of thrombotic events between the two treatment groups. (7) To assess the incidence of major bleeding events between the two treatment groups. (8) To assess the incidence of disease exacerbations between the two treatment groups. (9) Evaluate event-free survival (EFS) in both treatment groups. (10) Evaluate the safety and tolerability of bomedemstat.

Test Drug

MK-3543

Active Ingredient

Bomedemstat

Dosage Form

capsules

Dosage

10 mg/cap, 15 mg/cap, 20 mg/cap, 50mg/cap

Endpoints

(1) Compare the durable clinical hematologic response (DCHR) of bomedemstat with the best available therapy.

Inclution Criteria

Inclusion Criteria:

Has a diagnosis of ET per WHO 2016 diagnostic criteria for myeloproliferative neoplasms (confirmed by a central pathologist)
Has a centrally assessed bone marrow fibrosis score of Grade 0 or Grade 1, as per a modified version of the European Consensus Criteria for Grading Myelofibrosis
Has a history of inadequate response to or intolerance of hydroxyurea based on modified European LeukemiaNet (ELN) criteria for hydroxyurea resistance or intolerance
Has an inadequate or loss of response to their most recent prior ET therapy, requiring a change of cytoreductive therapy
Has a platelet count > 450 × 10^9/L (450k /μL) assessed up to 72 hours before first dose of study intervention
Has an absolute neutrophil count (ANC) ≥0.75 × 10^9/L assessed up to 72 hours before first dose of study intervention
Participants may have received up to 3 prior ET-directed cytoreductive agents including hydroxyurea

Exclusion Criteria

Exclusion Criteria:

Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to bomedemstat or lysine demethylase or monoamine oxidase inhibitor (LSDi or MAOi) or the chosen best available therapy (including anagrelide, interferon alfa/pegylated interferon, ruxolitinib, or busulfan) that contraindicates participation
History of any illness/impairment of GI function that might interfere with drug absorption (eg, chronic diarrhea or history of gastric bypass surgical procedure), confound the study results or pose an additional risk to the individual by participation in the study
Evidence at the time of Screening of increased risk of bleeding
History of a malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years. Note: The time requirement does not apply to participants who underwent successful definitive resection of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ, excluding carcinoma in situ of the bladder
Human immunodeficiency virus (HIV)-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease

The Estimated Number of Participants

  • Taiwan

    15 participants

  • Global

    340 participants

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