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RecruitingLast updated: 4 April 2025

This study is recruiting people with essential thrombocythemia who have not yet had cytoreductive therapy but for whom it is recommendedA 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

Trial purpose

Medical clipboardCancer treatment

Tumor type

Blood Cancers Haematological

Age

People18+

Clinical summary

Summary

The purpose of this study is to evaluate the efficacy and safety of bomedemstat compared with hydroxyurea in people with cytoreductive therapy naïve essential thrombocythemia (ET) for whome cytroreductive therapy is indicated.

Eligible participants will be randomly allocated to one of two treatment arms.

In the Experimental Arm, participants will receive active bomedemstat and hydroxyurea placebo daily for up to 52 weeks.

In the Active Comparator Arm, participants will receive active hydroxyurea and bomedemstat placebo daily for up to 52 weeks. 

In both arms, dosage will be adjusted either up or down within specified time parameters for each participant to the dose that provides sufficient exposure to safely inhibit thrombopoiesis to decrease platelet counts to the target range. All treatment will be given in the form of oral capsules.

Conditions

This trial is treating people with Essential Thrombocythemia who have not received prior cytoreductive treatment

Eligibility

Inclusion

  • 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
  • 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 received no prior cytoreductive treatment for their ET
  • Human Immunodeficiency Virus (HIV)-infected participants have well controlled HIV on antiretroviral therapy
  • 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
  • Participants with history of Hepatitis C Virus (HCV) infection are eligible if HCV viral load is undetectable

Exclusion

  • History of any illness/impairment of gastrointestinal function that might interfere with drug absorption
  • History of a malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years
  • HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
  • Has an active infection requiring systemic therapy
  • 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

Inclusion

  • You have been diagnosed with cancer, but have not received any treatment.
  • You are able to swallow medication by mouth.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

  • NCT06456346 *
  • 3543-007; 2023-505232-36; MK-3543-007; JRCT2031240181; U1111-1290-8287

Trial sponsor

Merck Sharp & Dohme LLC

Scientific 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

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