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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

    2026/02/01

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 陳苡揚 Division of Hematology & Oncology
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 Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Tsai-Yun Chen Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Essential Thrombocythemia

Objectives

main purpose: (1) To compare durable clinical hematologic response (DCHR) with bomedemstat versus best available therapy. Secondary purpose: (1) To compare changes in fatigue scores with bomedemstat versus best available therapy based on the Myelofibrosis Symptom Assessment Form version 4.0 (MFSAF v4.0). (2) To compare changes in total fatigue scores between bomedemstat and best available therapy based on the Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form 7a (SF-7a). (3) Compare changes in total symptom scores with bomedemstat and best available therapy according to MFSAF v4.0. (4) To assess duration of clinical hematologic response (DOCHR) in both treatment groups. (5) To assess duration of hematologic response (DOHR) in both treatment groups. (6) To assess the incidence of thrombotic events in both treatment groups. (7) To assess the incidence of major bleeding events in both treatment groups. (8) To assess the incidence of disease progression in both treatment groups. (9) To evaluate event-free survival (EFS) in both treatment groups. (10) To 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) To compare durable clinical hematologic response (DCHR) with bomedemstat versus best available therapy.

Inclution Criteria

Inclusion Criteria:

Has a diagnosis of ET per WHO 2016 diagnostic criteria for myeloproliferative neoplasms
Has a 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: hydroxyurea resistance (or inadequate response) or hydroxyurea 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 × 109/L (450k /μL) assessed up to 72 hours before first dose of study intervention
Has an absolute neutrophil count (ANC) ≥0.75 × 109/L assessed up to 72 hours before first dose of study intervention
Participants may have received up to 3 prior lines of therapy 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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