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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Bomedemstat 		Participants will receive active bomedemstat and hydroxyurea placebo daily for up to approximately 52 weeks. 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. Participants who complete treatment at Week 52 will be eligible to continue treatment in the extended treatment phase. Unblinding will occur and placebo discontinued once all participants have completed at least 52 weeks of therapy or otherwise discontinued.
  • Drug: Bomedemstat
    Oral capsule
    Other names:
    • MK-3543
    • IMG-7289
  • Drug: Hydroxyurea placebo
    Oral capsule placebo
Active Comparator
Hydroxyurea 		Participants will receive active hydroxyurea and bomedemstat placebo daily for up to 52 weeks. 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. Participants who complete treatment at Week 52 will be eligible to continue treatment in the extended treatment phase. Unblinding will occur and placebo discontinued once all participants have completed at least 52 weeks of therapy or otherwise discontinued.
  • Drug: Hydroxyurea
    Oral capsule
  • Drug: Bomedemstat placebo
    Oral capsule placebo

Recruiting Locations

Palo Verde Cancer Specialists ( Site 0052)
Glendale, Arizona 85304
Contact:
Study Coordinator
602-978-6255

Stanford Cancer Center ( Site 0024)
Palo Alto, California 94304
Contact:
Study Coordinator
650-498-6000

Exempla Lutheran Medical Center ( Site 0014)
Golden, Colorado 80401
Contact:
Study Coordinator
303-403-6381

Yale University School of Medicine ( Site 0051)
New Haven, Connecticut 06510
Contact:
Study Coordinator
203-737-4450

University of Michigan ( Site 0003)
Ann Arbor, Michigan 48109
Contact:
Study Coordinator
800-865-1125

Optum Care Cancer Center ( Site 0053)
Las Vegas, Nevada 89102
Contact:
Study Coordinator
702-724-8787

Levine Cancer Institute ( Site 0009)
Charlotte, North Carolina 28204
Contact:
Study Coordinator
980-442-2157

Duke University Health System (DUHS) ( Site 0012)
Durham, North Carolina 27710
Contact:
Study Coordinator
916-668-0657

Wake Forest Baptist Health-Internal Medicine, Section on Hematology & Oncology ( Site 0013)
Winston-Salem, North Carolina 27157
Contact:
Study Coordinator
336-713-5440

The Ohio State University Wexner Medical Center ( Site 0028)
Columbus, Ohio 43210
Contact:
Study Coordinator
614-293-5000

Oncology Associates of Oregon, P.C.(Willamette Valley Cancer Institute) (WVCI) ( Site 8005)
Eugene, Oregon 97401
Contact:
Study Coordinator
541-683-5001

Oregon Health & Science University ( Site 0018)
Portland, Oregon 97239
Contact:
Study Coordinator
503-494-8311

TriStar Bone Marrow ( Site 7000)
Nashville, Tennessee 37203
Contact:
Study Coordinator
615-329-7640

Texas Oncology - West Texas ( Site 8003)
Amarillo, Texas 79124
Contact:
Study Coordinator
915-747-4835

Texas Oncology - DFW ( Site 8006)
Dallas, Texas 75246
Contact:
Study Coordinator
214-370-1067

University of Texas MD Anderson Cancer Center ( Site 0026)
Houston, Texas 77030
Contact:
Study Coordinator
713-745-9200

University of Texas Health Science Center at San Antonio ( Site 0021)
San Antonio, Texas 78229
Contact:
Study Coordinator
210-450-1435

Texas Oncology - Gulf Coast ( Site 8008)
Webster, Texas 77598
Contact:
Study Coordinator
281-332-7505

University of Virginia ( Site 0020)
Charlottesville, Virginia 22908
Contact:
Study Coordinator
434-243-8108

VCU Health Adult Outpatient Pavillion ( Site 0008)
Richmond, Virginia 23219
Contact:
Study Coordinator
804-828-2177

More Details

Status
Recruiting
Sponsor
Merck Sharp & Dohme LLC

Study Contact

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.