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NCT06079879 · ClinicalTrials.gov registry record · Phase 3

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)

A Phase 3 study of Essential Thrombocythemia, sponsored by Merck Sharp & Dohme.

Recruiting
Registry status
Phase 3
Development phase
340
Enrollment target
20
Study locations

NCT06079879: Recruiting Phase 3 study of Essential Thrombocythemia, sponsored by Merck Sharp & Dohme.

NCT06079879 is a Phase 3 study of Essential Thrombocythemia that is actively recruiting participants, run by Merck Sharp & Dohme. The registered enrollment target is 340 participants, above the 66-participant average among 16 other Essential Thrombocythemia trials with a reported enrollment target (415% higher). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06079879, a Phase 3 study of Essential Thrombocythemia, is actively recruiting participants, sponsored by Merck Sharp & Dohme.

RECRUITING
Registry status
Phase 3
Development phase
340 participants
Enrollment target
20
Study locations

Study Summary

This is a study evaluating the safety and efficacy of bomedemstat (MK-3543) compared with the best available therapy (BAT) in participants with essential thrombocythemia (ET) who have an inadequate response to or are intolerant of hydroxyurea. The primary study hypothesis is that bomedemstat is superior to the best available therapy with respect to durable clinicohematologic response (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 and 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

Essential Thrombocythemia

Interventions

  • DRUG Busulfan
  • DRUG Ruxolitinib
  • DRUG Bomedemstat
  • DRUG Anagrelide
  • DRUG Interferon alfa/pegylated interferon alfa 2a/pegylated interferon alfa 2b

Study Locations (20)

California

  • Los Angeles Cancer Network ( Site 3491) - Glendale
  • Stanford Cancer Institute ( Site 0107) - Stanford
  • The Lundquist Institute ( Site 3423) - Torrance

Michigan

  • University of Michigan ( Site 0008) - Ann Arbor
  • Henry Ford Hospital ( Site 3413) - Detroit

North Carolina

  • Duke University Health System (DUHS) ( Site 0016) - Durham
  • Wake Forest Baptist Health-Internal Medicine, Section on Hematology & Oncology ( Site 3400) - Winston-Salem

Virginia

  • University of Virginia ( Site 3422) - Charlottesville
  • VCU Health Adult Outpatient Pavillion ( Site 3416) - Richmond

New South Wales

  • Royal Prince Alfred Hospital ( Site 1100) - Camperdown
  • Liverpool Hospital-Haematology ( Site 0501) - Liverpool

Arizona

  • Palo Verde Hematology/ Oncology Center, Ltd. ( Site 3496) - Glendale

Colorado

  • University of Colorado Anschutz Medical Campus ( Site 3425) - Aurora

Massachusetts

  • Tufts Medical Center ( Site 3408) - Boston

Trial Details

FieldValue
Enrollment Target 340 participants
Start Date 2023-12-31
Est. Completion 2028-08-18
Phase Phase 3
Merck Sharp & Dohme

558 total trials

What NCT06079879 shows while recruiting

NCT06079879 is an interventional study that assigns participants to a tested intervention. The registered 340 participants enrollment target is mid-sized for trials with a published cap, above the 66-participant average among 16 other Essential Thrombocythemia trials with a reported enrollment target (415% higher).

The record links to 1 condition, with Essential Thrombocythemia appearing as the primary indexed condition, and to 5 interventions - of which Busulfan is the first listed.

NCT06079879 names 20 study sites across 14 states, led by California, Michigan, North Carolina.

Frequently Asked Questions

What is clinical trial NCT06079879 about?

NCT06079879 is a clinical study titled "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)". This is a study evaluating the safety and efficacy of bomedemstat (MK-3543) compared with the best available therapy (BAT) in participants with essential thrombocythemia (ET) who have an inadequate response to or are intolerant of hydroxyurea. The primary study hypothesis is that bomedemstat is supe...

What is the current status of trial NCT06079879?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 340 participants. The study started on 2023-12-31. Estimated completion is 2028-08-18.

What conditions does trial NCT06079879 study?

This clinical trial studies the following conditions: Essential Thrombocythemia.

What interventions are being tested in trial NCT06079879?

The interventions under investigation include: Busulfan (DRUG), Ruxolitinib (DRUG), Bomedemstat (DRUG), Anagrelide (DRUG), Interferon alfa/pegylated interferon alfa 2a/pegylated interferon alfa 2b (DRUG).

Who is sponsoring clinical trial NCT06079879?

This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06079879 being conducted?

This trial has 20 study locations across Arizona, California, Colorado, Massachusetts, Michigan. 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 NCT06079879's enrollment target sits among peer trials

340 1st of 16 higher than 16 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

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More recruiting context for NCT06079879

Source: ClinicalTrials.gov NCT06079879, the US trial registry maintained by the National Library of Medicine. NCT06079879 (mid enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.