Comparing bomedemstat and hydroxyurea for treating essential thrombocythemia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the efficacy and safety of bomedemstat compared to hydroxyurea in patients with essential thrombocythemia who have not previously received cytoreductive therapy. The primary objective is to determine if bomedemstat provides a superior durable clinicohematologic response compared to hydroxyurea. Participants will be monitored for their response to treatment and any adverse effects. The study includes both active treatments and placebo groups to ensure robust results.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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

Where it's running

• Palo Verde Cancer Specialists ( Site 0052)
  Glendale, Arizona, United States Recruiting
• Los Angeles Cancer Network ( Site 0025)
  Glendale, California, United States Recruiting
• Stanford Cancer Center ( Site 0024)
  Palo Alto, California, United States Recruiting
• Exempla Lutheran Medical Center ( Site 0014)
  Golden, Colorado, United States Recruiting
• Yale University School of Medicine ( Site 0051)
  New Haven, Connecticut, United States Recruiting
• University of Michigan ( Site 0003)
  Ann Arbor, Michigan, United States Recruiting

+120 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Toll Free Number
• Email: Trialsites@msd.com
• Phone: 1-888-577-8839

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• A Phase 3 Test of INCA033989 vs Best Available Therapy for Essential Thrombocythemia with CALR Mutation

  This phase 3 study tests whether INCA033989 can help people with essential thrombocythemia who have a CALR mutation and have already had cytoreductive therapy, compared to the best available treatment.

  Recruiting at 5 sites Phase 3 Incyte Corporation · Birmingham, Alabama and 191 other locations · NCT07623200

• Evaluating Peginterferon for treating Essential Thrombocythemia and Polycythemia Vera

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• Peginterferon α-2b for patients with resistant or intolerant Essential Thrombocythemia

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.