Your session is about to expire
← Back to Search
Histone Methyltransferase Inhibitor
Bomedemstat vs Hydroxyurea for Essential Thrombocythemia
Phase 3
Recruiting
Research Sponsored by Merck Sharp & Dohme LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of Essential Thrombocythemia (ET) based on World Health Organization Criteria for myeloproliferative neoplasms, and in indication for cytoreductive therapy
Has received no prior cytoreductive treatment for their ET
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to week 52
Awards & highlights
Pivotal Trial
Summary
This trial aims to see if bomedemstat is better and safer than hydroxyurea for treating essential thrombocythemia. The main goal is to compare the two drugs based on their
Who is the study for?
This trial is for individuals with Essential Thrombocythemia (ET) who need cytoreductive therapy but haven't had any such treatment before. Participants must meet specific criteria, including controlled HIV or hepatitis if present, and a low bone marrow fibrosis score.
What is being tested?
The study compares the effectiveness and safety of bomedemstat to hydroxyurea in treating ET. Patients will be randomly assigned to receive either bomedemstat or hydroxyurea, aiming to see which one better achieves a durable clinicohematologic response.
What are the potential side effects?
Potential side effects for both treatments may include digestive issues, headaches, dizziness, skin reactions, and an increased risk of infections. The exact side effects will vary between the two drugs.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with Essential Thrombocythemia and need treatment to reduce my blood cell count.
Select...
I have not had treatment to reduce my blood cell count.
Select...
My HIV is well controlled with medication.
Select...
My bone marrow fibrosis is low grade.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to week 52
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to week 52
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Durable Clinicohematologic Response (DCHR) Rate
Secondary study objectives
Change From Baseline in MFSAF v4.0 Total Symptom Score
Change From Baseline in Myelofibrosis Symptom Assessment Form version 4.0 (MFSAF v4.0) Individual Fatigue Symptom Item Score
Change From Baseline in Patient-reported Outcomes Measurement Information System (PROMIS) Fatigue SF-7a Total Fatigue Score
+6 moreAwards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: BomedemstatExperimental Treatment2 Interventions
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.
Group II: HydroxyureaActive Control2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bomedemstat
2021
Completed Phase 2
~250
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme LLCLead Sponsor
4,031 Previous Clinical Trials
5,189,404 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,905 Previous Clinical Trials
8,090,685 Total Patients Enrolled