Clinical trial NCT06351631: A Study to Evaluate Safety and Efficacy of Bomedemstat (MK-3543-017)
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Thrombocythemia, Essential
Primary Myelofibrosis
Myelofibrosis
Post-polycythemia Vera Myelofibrosis
Post-essential Thrombocythemia Myelofibrosis
Polycythemia Vera
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2024-04-08
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Percentage of participants with one or more adverse events (AEs)
timeFrame: Up to ~10 years
measure: Percentage of participants who discontinued study treatment due to an AE
timeFrame: Up to ~10 years
Secondary outcomes:
measure: For participants with ET or PV: Duration of clinicohematologic response
timeFrame: Up to ~10 years
measure: For participants with ET or PV: Duration of hematologic remission
timeFrame: Up to ~10 years
measure: For participants with ET or PV: Percentage of participants with transformation to MF or MDS/AML
timeFrame: Up to ~10 years
measure: For participants with MF: Percentage of participants with worsening of splenomegaly or transformation to MDS/AML
timeFrame: Up to ~10 years
measure: For participants with MF, ET, or PV: Percentage of participants with thrombotic events
timeFrame: Up to ~10 years
measure: For participants with MF, ET, or PV: Percentage of participants with major hemorrhagic events
timeFrame: Up to ~10 years
measure: For participants with MF, ET, or PV: Event-Free Survival (EFS)
timeFrame: Up to ~10 years
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan ( Site 6000)
state: Michigan
city: Durham
country: United States
facility: DUHS Duke Blood Cancer Center ( Site 6005)
state: North Carolina
city: Columbus
country: United States
facility: The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C ( Site 6007)
state: Ohio
city: Pittsburgh
country: United States
facility: UPMC Hillman Cancer Center ( Site 6004)
state: Pennsylvania
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital ( Site 1003)
state: New South Wales
city: St Leonards
country: Australia
facility: Royal North Shore Hospital ( Site 1001)
state: New South Wales
city: Buderim
country: Australia
facility: Sunshine Coast Hematology and Oncology Clinic ( Site 1006)
state: Queensland
city: Southport
country: Australia
facility: Gold Coast University Hospital-Cancer and Blood Disorders Clinical Trial Team ( Site 1002)
state: Queensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital-Haematology Clinical Trials Unit ( Site 1000)
state: South Australia
city: Hksar
country: Hong Kong
facility: Queen Mary Hospital ( Site 1601)
city: Alessandria
country: Italy
facility: Azienda Ospedaliero-Universitaria SS. Antonio e Biagio e Cesare Arrigo ( Site 2703)
state: Ancona
city: Firenze
country: Italy
facility: Azienda Ospedaliera Universitaria Careggi ( Site 2700)
state: Toscana
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola ( Site 2702)
city: Varese
country: Italy
facility: Ospedale di Circolo e Fondazione Macchi Varese ( Site 2701)
city: Auckland
country: New Zealand
facility: North Shore Hospital-Department of Haematology ( Site 1401)
city: Auckland
country: New Zealand
facility: Aotearoa Clinical Trials ( Site 1400)
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust - Hammersmith Hospital ( Site 3402)
state: Hammersmith And Fulham
city: Boston
country: United Kingdom
facility: Boston Pilgrim Hospital ( Site 3403)
state: Lincolnshire
city: London
country: United Kingdom
facility: University College London Hospital ( Site 3400)
state: London, City Of
city: London
country: United Kingdom
facility: Guy's & St Thomas' NHS Foundation Trust ( Site 3401)
state: London, City Of
Study officials:
affiliation: Merck Sharp and Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: