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NCT06351631 | RECRUITING | Thrombocythemia, Essential

A Study to Evaluate Safety and Efficacy of Bomedemstat (MK-3543-017)
Sponsor:

Merck Sharp & Dohme LLC

Brief 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.

Condition or disease

Thrombocythemia, Essential

Primary Myelofibrosis

Myelofibrosis

Post-polycythemia Vera Myelofibrosis

Post-essential Thrombocythemia Myelofibrosis

Polycythemia Vera

Intervention/treatment

Bomedemstat

Phase

PHASE3

Study Type : INTERVENTIONAL
Estimated Enrollment : 400 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : A Multicenter, Open-Label, Extension Study Evaluating the Safety and Efficacy of Bomedemstat for the Treatment of Participants Enrolled in a Prior Bomedemstat Clinical Study
Actual Study Start Date : 2024-05-23
Estimated Primary Completion Date : 2034-12-04
Estimated Study Completion Date : 2034-12-04

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * Is from a bomedemstat study sponsored by Imago BioSciences, Inc. (a subsidiary of Merck \& Co., Inc.) or MSD, and established by the Sponsor as MK-3543-017 ready
  • * Has received at least 6 months of treatment with bomedemstat in the IMG-7289-202/MK-3543-005 study, while safely tolerating bomedemstat, and receiving clinical benefit from its use in the estimation of the investigator
  • * ET and PV participants from established feeder studies other than IMG-7289- 202/MK-3543-005 must have achieved confirmed hematologic remission, must be safely tolerating bomedemstat, and must be receiving clinical benefit from its use in the estimation of the investigator
  • * Is not currently on a dose hold
  • * Participant must be able to swallow oral medication and follow instructions for at-home dosing of bomedemstat
Exclusion Criteria
  • * Has received prohibited concomitant medications
  • * Ongoing or planned participation in another investigational study
  • * Has noncompliance in prior bomedemstat study receiving \<90% of assigned doses excluding suspensions or holds as assigned by the investigator
A Study to Evaluate Safety and Efficacy of Bomedemstat (MK-3543-017)

Location Details

NCT06351631

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Road cancer

University of Michigan ( Site 6000)

Ann Arbor, Road cancer, United States, 48109

RECRUITING

United States, Pennsylvania

UPMC Hillman Cancer Center ( Site 6004)

Pittsburgh, Pennsylvania, United States, 15232

RECRUITING

Australia, New South Wales

Royal Prince Alfred Hospital ( Site 1003)

Camperdown, New South Wales, Australia, 2050

RECRUITING

Australia, New South Wales

Royal North Shore Hospital ( Site 1001)

St Leonards, New South Wales, Australia, 2065

RECRUITING

Australia, Queensland

Gold Coast University Hospital-Cancer and Blood Disorders Clinical Trial Team ( Site 1002)

Southport, Queensland, Australia, 4215

RECRUITING

Australia, South Australia

Royal Adelaide Hospital-Haematology Clinical Trials Unit ( Site 1000)

Adelaide, South Australia, Australia, 5000

ACTIVE NOT RECRUITING

Hong Kong,

Queen Mary Hospital ( Site 1601)

Hkar, Hong Kong,

RECRUITING

Italy, Ancona

Hospital-University SS. Antonio and Biagio and Cesare Arrigo (Site 2703)

Alexandria, Ancona, Italy, 15121

RECRUITING

Italy, Tuscany

Careggi University Hospital (Site 2700)

Firenze, Tuscany, Italy, 50134

RECRUITING

Italy,

IRCCS Hospital-University of Bologna, Polyclinic of Sant'Orsola (Site 2702)

Bologna, Italy, 40138

RECRUITING

Italy,

Circolo Hospital and Macchi Varese Foundation (Site 2701)

Varese, Italy, 21100

ACTIVE NOT RECRUITING

New Zealand,

North Shore Hospital-Department of Haematology ( Site 1401)

Auckland, New Zealand, 0622

ACTIVE NOT RECRUITING

New Zealand,

Aotearoa Clinical Trials ( Site 1400)

Auckland, New Zealand, 2025

RECRUITING

United Kingdom, London, City Of

University College London Hospital ( Site 3400)

London, London, City Of, United Kingdom, NW1 2PG

RECRUITING

United Kingdom, London, City Of

Guy's & St Thomas' NHS Foundation Trust ( Site 3401)

London, London, City Of, United Kingdom, SE1 9RT