RECRUITING

Bomedemstat vs Hydroxyurea for Essential Thrombocythemia (MK-3543-007)

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

The purpose of this study is to evaluate the efficacy and safety of bomedemstat compared with hydroxyurea in cytoreductive therapy naïve essential thrombocythemia (ET) participants for whom cytoreductive therapy is indicated. Its primary objective is to compare bomedemstat to hydroxyurea with respect to durable clinicohematologic response (DCHR). The primary hypothesis is that bomedemstat is superior to hydroxyurea with respect to DCHR.

Official Title

A Phase 3, Randomized, Double-blind, Active-Comparator-Controlled Clinical Study to Evaluate the Efficacy and Safety of Bomedemstat (MK-3543) Versus Hydroxyurea in Cytoreductive Therapy Naïve Essential Thrombocythemia Participants

Quick Facts

Study Start:2024-07-16
Study Completion:2029-04-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06456346

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. * Diagnosis of Essential Thrombocythemia (ET) based on World Health Organization Criteria for myeloproliferative neoplasms, and an indication for cytoreductive therapy regardless of age or risk status
  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 received no prior cytoreductive treatment for their ET
  4. * Human Immunodeficiency Virus (HIV)-infected participants have well controlled HIV on antiretroviral therapy
  5. * Participants who are Hepatitis B surface antigen (HBsAg) positive are eligible if they have received Hepatitis B Virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load
  6. * Participants with history of Hepatitis C Virus (HCV) infection are eligible if HCV viral load is undetectable
  1. * History of any illness/impairment of gastrointestinal function that might interfere with drug absorption
  2. * History of a malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years
  3. * HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
  4. * Has an active infection requiring systemic therapy
  5. * Has had a major surgery \<4 weeks prior to first dose of study intervention or has not recovered from side effects of major surgery \>4 weeks prior to first dose

Contacts and Locations

Study Contact

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

Principal Investigator

Medical Director
STUDY_DIRECTOR
Merck Sharp & Dohme LLC

Study Locations (Sites)

Parkview Research Center at Parkview Regional Medical Center ( Site 0006)
Fort Wayne, Indiana, 46845
United States
Duke University Health System (DUHS) ( Site 0012)
Durham, North Carolina, 27710
United States

Collaborators and Investigators

Sponsor: Merck Sharp & Dohme LLC

  • Medical Director, STUDY_DIRECTOR, Merck Sharp & 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 Date2024-07-16
Study Completion Date2029-04-15

Study Record Updates

Study Start Date2024-07-16
Study Completion Date2029-04-15

Terms related to this study

Keywords Provided by Researchers

  • essential thrombocythemia
  • ET
  • bomedemstat
  • IMG-7289

Additional Relevant MeSH Terms

  • Essential Thrombocythemia