RECRUITING

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)

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Conditions

Essential ThrombocythemiaETbomedemstatIMG-7289

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

Official Title

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

Quick Facts

Study Start:2023-12-31
Study Completion:2028-08-18
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06079879

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Has a diagnosis of ET per WHO 2016 diagnostic criteria for myeloproliferative neoplasms (confirmed by a central pathologist)
  2. * 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
  3. * Has a history of inadequate response to or intolerance of hydroxyurea based on modified European LeukemiaNet (ELN) criteria for hydroxyurea resistance or intolerance
  4. * Has an inadequate or loss of response to their most recent prior ET therapy, requiring a change of cytoreductive therapy
  5. * Has a platelet count \> 450 × 10\^9/L (450k /μL) assessed up to 72 hours before first dose of study intervention
  6. * Has an absolute neutrophil count (ANC) ≥0.75 × 10\^9/L assessed up to 72 hours before first dose of study intervention
  7. * Participants may have received up to 3 prior ET-directed cytoreductive agents including hydroxyurea
  1. * 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
  2. * 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
  3. * Evidence at the time of Screening of increased risk of bleeding
  4. * 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
  5. * Human immunodeficiency virus (HIV)-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease

Contacts and Locations

Study Contact

Toll Free Number
CONTACT
1-888-577-8839
Trialsites@msd.com

Principal Investigator

Medical Director
STUDY_DIRECTOR
Merck Sharpe & Dohme LLC

Study Locations (Sites)

Stanford Cancer Institute ( Site 0107)
Stanford, California, 94305-5826
United States
Tufts Medical Center ( Site 3408)
Boston, Massachusetts, 02111
United States
University of Michigan ( Site 0008)
Ann Arbor, Michigan, 48109
United States
Henry Ford Hospital ( Site 3413)
Detroit, Michigan, 48202
United States
Roswell Park Cancer Institute ( Site 3421)
Buffalo, New York, 14263
United States
Duke University Health System (DUHS) ( Site 0016)
Durham, North Carolina, 27710
United States
Wake Forest Baptist Health-Internal Medicine, Section on Hematology & Oncology ( Site 3400)
Winston-Salem, North Carolina, 27157
United States
University of Virginia ( Site 3422)
Charlottesville, Virginia, 22908
United States
VCU Health Adult Outpatient Pavillion ( Site 3416)
Richmond, Virginia, 23219
United States

Collaborators and Investigators

Sponsor: Merck Sharp & Dohme LLC

  • Medical Director, STUDY_DIRECTOR, Merck Sharpe & Dohme LLC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-31
Study Completion Date2028-08-18

Study Record Updates

Study Start Date2023-12-31
Study Completion Date2028-08-18

Terms related to this study

Keywords Provided by Researchers

  • essential thrombocythemia
  • ET
  • bomedemstat
  • IMG-7289

Additional Relevant MeSH Terms

  • Essential Thrombocythemia