A Study of Bomedemstat (IMG-7289/MK-3543) Compared to Best Available Therapy (BAT) in Participants With Essential Thrombocythemia and an Inadequate Response or Intolerance of Hydroxyurea (MK-3543-006)

Description

This is a study evaluating the safety and efficacy of bomedemstat (MK-3543) compared with the best available therapy (BAT) in participants with essential thrombocythemia (ET) who have an inadequate response to or are intolerant of hydroxyurea. The primary study hypothesis is that bomedemstat is superior to the best available therapy with respect to durable clinicohematologic response (DCHR).

Conditions

Essential Thrombocythemia

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Study Overview

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Study Details

Study overview

This is a study evaluating the safety and efficacy of bomedemstat (MK-3543) compared with the best available therapy (BAT) in participants with essential thrombocythemia (ET) who have an inadequate response to or are intolerant of hydroxyurea. The primary study hypothesis is that bomedemstat is superior to the best available therapy with respect to durable clinicohematologic response (DCHR).

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

A Study of Bomedemstat (IMG-7289/MK-3543) Compared to Best Available Therapy (BAT) in Participants With Essential Thrombocythemia and an Inadequate Response or Intolerance of Hydroxyurea (MK-3543-006)

Condition
Essential Thrombocythemia
Intervention / Treatment

-

Contacts and Locations

Stanford

Stanford Cancer Institute ( Site 0107), Stanford, California, United States, 94305-5826

Boston

Tufts Medical Center ( Site 3408), Boston, Massachusetts, United States, 02111

Ann Arbor

University of Michigan ( Site 0008), Ann Arbor, Michigan, United States, 48109

Detroit

Henry Ford Hospital ( Site 3413), Detroit, Michigan, United States, 48202

Buffalo

Roswell Park Cancer Institute ( Site 3421), Buffalo, New York, United States, 14263

Durham

Duke University Health System (DUHS) ( Site 0016), Durham, North Carolina, United States, 27710

Winston-Salem

Wake Forest Baptist Health-Internal Medicine, Section on Hematology & Oncology ( Site 3400), Winston-Salem, North Carolina, United States, 27157

Charlottesville

University of Virginia ( Site 3422), Charlottesville, Virginia, United States, 22908

Richmond

VCU Health Adult Outpatient Pavillion ( Site 3416), Richmond, Virginia, United States, 23219

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Merck Sharp & Dohme LLC,

Medical Director, STUDY_DIRECTOR, Merck Sharpe & Dohme LLC

Study Record Dates

2028-08-18