A Study to Evaluate Safety and Efficacy of Bomedemstat (MK-3543-017)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Bomedemstat.
- Who it may be relevant to
- Registry conditions: Thrombocythemia, Essential, Primary Myelofibrosis, Myelofibrosis, Post-polycythemia Vera Myelofibrosis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Australia, Hong Kong, Italy, New Zealand +1
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- Drug Bomedemstat
10, 15, 20, and 50 mg oral capsules
Primary outcome measures
- Percentage of participants with one or more adverse events (AEs) [Time frame: Up to ~10 years]
- Percentage of participants who discontinued study treatment due to an AE [Time frame: Up to ~10 years]
Secondary outcome measures (6)
- For participants with ET or PV: Duration of clinicohematologic response [Time frame: Up to ~10 years]
- For participants with ET or PV: Duration of hematologic remission [Time frame: Up to ~10 years]
- For participants with ET or PV: Percentage of participants with transformation to MF or MDS/AML [Time frame: Up to ~10 years]
- For participants with MF: Percentage of participants with worsening of splenomegaly or transformation to MDS/AML [Time frame: Up to ~10 years]
- For participants with MF, ET, or PV: Percentage of participants with thrombotic events [Time frame: Up to ~10 years]
- For participants with MF, ET, or PV: Percentage of participants with major hemorrhagic events [Time frame: Up to ~10 years]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Australia · 6 centers
- Royal Prince Alfred Hospital ( Site 1003) — Camperdown
- Royal North Shore Hospital ( Site 1001) — St Leonards
- Sunshine Coast Hematology and Oncology Clinic ( Site 1006) — Buderim
- Gold Coast University Hospital-Cancer and Blood Disorders Clinical Trial Team ( Site 1002) — Southport
- Royal Adelaide Hospital-Haematology Clinical Trials Unit ( Site 1000) — Adelaide
- Monash Health ( Site 1004) — Clayton
United States · 4 centers
- University of Michigan ( Site 6000) — Ann Arbor
- DUHS Duke Blood Cancer Center ( Site 6005) — Durham
- The James Cancer Hospital and Solove Research Institute at The Ohio State University Compr — Columbus
- UPMC Hillman Cancer Center ( Site 6004) — Pittsburgh
Italy · 4 centers
- Azienda Ospedaliera Universitaria Careggi ( Site 2700) — Florence
- 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
United Kingdom · 4 centers
- Imperial College Healthcare NHS Trust - Hammersmith Hospital ( Site 3402) — London
- Boston Pilgrim Hospital ( Site 3403) — Boston
- University College London Hospital ( Site 3400) — London
- Guy's & St Thomas' NHS Foundation Trust ( Site 3401) — London
New Zealand · 2 centers
- North Shore Hospital-Department of Haematology ( Site 1401) — Auckland
- Aotearoa Clinical Trials ( Site 1400) — Auckland
Hong Kong · 1 center
- Queen Mary Hospital ( Site 1601) — Hksar
Identifiers
NCT: NCT06351631 · 3543-017 · 2023-506996-89-00 · U1111-1294-8621 · MK-3543-017