Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT06351631 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate Safety and Efficacy of Bomedemstat (MK-3543-017)
A Phase 3 study of Myelofibrosis and Primary Myelofibrosis, sponsored by Merck Sharp & Dohme.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 400
- Enrollment target
- 20
- Study locations
NCT06351631 is a Phase 3 study of Myelofibrosis and Primary Myelofibrosis that is actively recruiting participants, run by Merck Sharp & Dohme. The registered enrollment target is 400 participants, above the 189-participant average among 61 other Myelofibrosis trials with a reported enrollment target (112% higher). The trial reports 20 study locations across 13 states.
The verdict
NCT06351631, a Phase 3 study of Myelofibrosis and Primary Myelofibrosis, is actively recruiting participants, sponsored by Merck Sharp & Dohme.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 400 participants
- Enrollment target
- 20
- Study locations
Study Summary
The primary purpose of the study is to transition participants into an extension study to collect long-term safety and efficacy data. The study will include participants who are safely tolerating bomedemstat, receiving clinical benefit from its use in estimation of the investigator, and have shown the following criteria: * Participants from the IMG-7289-202/MK-3543-005 (NCT05223920) study must have received at least 6 months of treatment with bomedemstat; * Essential thrombocythemia (ET) and polycythemia vera (PV) participants from studies other than IMG-7289-202/MK-3543-005 must have achieved confirmed hematologic remission. No hypothesis testing will be conducted in this study.
Conditions Studied
Interventions
- DRUG Bomedemstat
Study Locations (20)
Other
- Queen Mary Hospital ( Site 1601) - Hksar
- Azienda Ospedaliero-Universitaria SS. Antonio e Biagio e Cesare Arrigo ( Site 2703) - Alessandria
- IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola ( Site 2702) - Bologna
- Ospedale di Circolo e Fondazione Macchi Varese ( Site 2701) - Varese
- North Shore Hospital-Department of Haematology ( Site 1401) - Auckland
- Aotearoa Clinical Trials ( Site 1400) - Auckland
New South Wales
- Royal Prince Alfred Hospital ( Site 1003) - Camperdown
- Royal North Shore Hospital ( Site 1001) - St Leonards
Queensland
- Sunshine Coast Hematology and Oncology Clinic ( Site 1006) - Buderim
- Gold Coast University Hospital-Cancer and Blood Disorders Clinical Trial Team ( Site 1002) - Southport
Michigan
- University of Michigan ( Site 6000) - Ann Arbor
North Carolina
- DUHS Duke Blood Cancer Center ( Site 6005) - Durham
Ohio
- The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C ( Site 6007) - Columbus
Pennsylvania
- UPMC Hillman Cancer Center ( Site 6004) - Pittsburgh
South Australia
- Royal Adelaide Hospital-Haematology Clinical Trials Unit ( Site 1000) - Adelaide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 400 participants |
| Start Date | 2024-05-23 |
| Est. Completion | 2034-12-04 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06351631
The ClinicalTrials.gov registry entry for NCT06351631 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 400 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 189-participant average among 61 other Myelofibrosis trials with a reported enrollment target (112% higher). The listed sponsor is Merck Sharp & Dohme, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 6 conditions, with Myelofibrosis appearing as the primary indexed condition, and to 1 intervention - of which Bomedemstat is the first listed.
NCT06351631 reports 20 study locations spanning 13 distinct geographic areas - top geographies include Other, New South Wales, Queensland.
Frequently Asked Questions
What is clinical trial NCT06351631 about?
NCT06351631 is a clinical study titled "A Study to Evaluate Safety and Efficacy of Bomedemstat (MK-3543-017)". The primary purpose of the study is to transition participants into an extension study to collect long-term safety and efficacy data. The study will include participants who are safely tolerating bomedemstat, receiving clinical benefit from its use in estimation of the investigator, and have shown t...
What is the current status of trial NCT06351631?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 400 participants. The study started on 2024-05-23. Estimated completion is 2034-12-04.
What conditions does trial NCT06351631 study?
This clinical trial studies the following conditions: Myelofibrosis, Primary Myelofibrosis, Polycythemia Vera, Post-Essential Thrombocythemia Myelofibrosis, Post-Polycythemia Vera Myelofibrosis.
What interventions are being tested in trial NCT06351631?
The interventions under investigation include: Bomedemstat (DRUG).
Who is sponsoring clinical trial NCT06351631?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06351631 being conducted?
This trial has 20 study locations across Michigan, North Carolina, Ohio, Pennsylvania, New South Wales. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Myelofibrosis
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.
-
Study of Navtemadlin add-on to Ruxolitinib in JAK Inhibitor-Naïve Patients With Myelofibrosis Who Have a Suboptimal Response to Ruxolitinib
RECRUITING · Phase 3
-
Haploidentical Allogeneic Peripheral Blood Transplantation: Examining Checkpoint Immune Regulators' Expression
ACTIVE NOT RECRUITING · Phase 3
-
An Efficacy and Safety Study of Luspatercept (ACE-536) Versus Placebo in Subjects With Myeloproliferative Neoplasm-Associated Myelofibrosis on Concomitant JAK2 Inhibitor Therapy and Who Require Red Blood Cell Transfusions
ACTIVE NOT RECRUITING · Phase 3
-
Study of Selinexor in Combination With Ruxolitinib in Myelofibrosis
ACTIVE NOT RECRUITING · Phase 3
-
A Study Comparing Imetelstat Versus Best Available Therapy for the Treatment of Intermediate-2 or High-risk Myelofibrosis (MF) Who Have Not Responded to Janus Kinase (JAK)-Inhibitor Treatment
ACTIVE NOT RECRUITING · Phase 3
-
Phase 3 Study of Pelabresib (CPI-0610) in Myelofibrosis (MF) (MANIFEST-2)
ACTIVE NOT RECRUITING · Phase 3
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.