Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT06456346 · ClinicalTrials.gov registry record · Phase 3
Bomedemstat vs Hydroxyurea for Essential Thrombocythemia (MK-3543-007)
A Phase 3 study of Essential Thrombocythemia, sponsored by Merck Sharp & Dohme.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 300
- Enrollment target
- 20
- Study locations
NCT06456346: Recruiting Phase 3 study of Essential Thrombocythemia, sponsored by Merck Sharp & Dohme.
NCT06456346 is a Phase 3 study of Essential Thrombocythemia that is actively recruiting participants, run by Merck Sharp & Dohme. The registered enrollment target is 300 participants, above the 69-participant average among 16 other Essential Thrombocythemia trials with a reported enrollment target (335% higher). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06456346, a Phase 3 study of Essential Thrombocythemia, is actively recruiting participants, sponsored by Merck Sharp & Dohme.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 300 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
DCHR rate is the percentage of participants with DCHR, defined as a confirmed reduction of platelet count to ≤400 × 10\^9/L, absence of white blood cell (WBC) count elevation to \>10 × 10\^9/L locally assessed to be due to ET, starting by Week 24 and maintained for at least 24 weeks, and the absence of any thrombotic or major hemorrhagic events or disease progression to myelofibrosis (MF), myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) by Week 52.
Conditions Studied
Interventions
- DRUG Hydroxyurea
- DRUG Bomedemstat
- DRUG Bomedemstat placebo
- DRUG Hydroxyurea placebo
Study Locations (20)
North Carolina
- Levine Cancer Institute ( Site 0009) - Charlotte
- Duke University Health System (DUHS) ( Site 0012) - Durham
- Wake Forest Baptist Health-Internal Medicine, Section on Hematology & Oncology ( Site 0013) - Winston-Salem
California
- Los Angeles Cancer Network ( Site 0025) - Glendale
- Stanford Cancer Center ( Site 0024) - Palo Alto
Texas
- University of Texas MD Anderson Cancer Center ( Site 0026) - Houston
- University of Texas Health Science Center at San Antonio ( Site 0021) - San Antonio
Virginia
- University of Virginia ( Site 0020) - Charlottesville
- VCU Health Adult Outpatient Pavillion ( Site 0008) - Richmond
Arizona
- Palo Verde Cancer Specialists ( Site 0052) - Glendale
Colorado
- Exempla Lutheran Medical Center ( Site 0014) - Golden
Connecticut
- Yale University School of Medicine ( Site 0051) - New Haven
Indiana
- Parkview Research Center at Parkview Regional Medical Center ( Site 0006) - Fort Wayne
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2024-07-16 |
| Est. Completion | 2028-03-24 |
| Phase | Phase 3 |
What NCT06456346 shows while recruiting
NCT06456346 is an interventional study that assigns participants to a tested intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap, above the 69-participant average among 16 other Essential Thrombocythemia trials with a reported enrollment target (335% higher).
The record links to 1 condition, with Essential Thrombocythemia appearing as the primary indexed condition, and to 4 interventions - of which Hydroxyurea is the first listed.
NCT06456346 names 20 study sites across 15 states, led by North Carolina, California, Texas.
Frequently Asked Questions
What is clinical trial NCT06456346 about?
NCT06456346 is a clinical study titled "Bomedemstat vs Hydroxyurea for Essential Thrombocythemia (MK-3543-007)". 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 respec...
What is the current status of trial NCT06456346?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 300 participants. The study started on 2024-07-16. Estimated completion is 2028-03-24.
What conditions does trial NCT06456346 study?
This clinical trial studies the following conditions: Essential Thrombocythemia.
What interventions are being tested in trial NCT06456346?
The interventions under investigation include: Hydroxyurea (DRUG), Bomedemstat (DRUG), Bomedemstat placebo (DRUG), Hydroxyurea placebo (DRUG).
Who is sponsoring clinical trial NCT06456346?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06456346 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Connecticut, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Essential Thrombocythemia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06456346's enrollment target sits among peer trials
300 2nd of 16 the highest of 16 other Essential Thrombocythemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Essential Thrombocythemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
A Study of Bomedemstat (IMG-7289/MK-3543) Compared to Best Available Therapy (BAT) in Participants With Essential Thrombocythemia and an Inadequate Response or Intolerance of Hydroxyurea (MK-3543-006)
RECRUITING · Phase 3
-
Ropeginterferon Alfa-2b (P1101) vs. Anagrelide in Essential Thrombocythemia Patients With Hydroxyurea Resistance or Intolerance
ACTIVE NOT RECRUITING · Phase 3
-
A Randomized Study of ASTX727 With or Without Iadademstat in Advanced Myeloproliferative Neoplasms (MPNs)
RECRUITING · Phase 2
-
Ruxolitinib in Thrombocythemia and Polycythemia Vera
RECRUITING · Phase 2
-
Mutant CALR-peptide Based Vaccine in Patients With Mutated CALR Myeloproliferative Neoplasm
RECRUITING · Phase 1
-
Two Step Haplo With Radiation Conditioning
RECRUITING · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00353483 · 300 participants
Effect of Neoadjuvant or Adjuvant Systemic Therapy on Breast Cancers, Bone Marrow Cancer Cells, and Circulating Cancer Cells
- NCT00588185 · 300 participants · NA
[18F]-Fluoro-2-Deoxy-D-Glucose and -[18F] Dihydro-Testosterone Pet Imaging in Patients With Progressive Prostate Cancer
- NCT00682032 · 300 participants · NA
The Effect of Beta-glucan in Non-Small Cell Lung Cancer
- NCT00870064 · 300 participants · NA
The Treatment of Type I Open Fractures in Pediatrics
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI