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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT06351631
Registration number
NCT06351631
Ethics application status
Date submitted
2/04/2024
Date registered
8/04/2024
Date last updated
29/05/2024
Titles & IDs
Public title
A Study to Evaluate Safety and Efficacy of Bomedemstat (MK-3543-017)
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Scientific 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
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Secondary ID [1]
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2023-506996-89
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Secondary ID [2]
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3543-017
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Thrombocythemia, Essential
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Primary Myelofibrosis
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Myelofibrosis
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Post-polycythemia Vera Myelofibrosis
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Post-essential Thrombocythemia Myelofibrosis
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Polycythemia Vera
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Condition category
Condition code
Blood
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Haematological diseases
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Blood
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Other blood disorders
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Musculoskeletal
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Other muscular and skeletal disorders
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Human Genetics and Inherited Disorders
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Other human genetics and inherited disorders
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Cancer
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Leukaemia - Chronic leukaemia
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Bomedemstat
Experimental: Bomedemstat - Participants will receive oral capsules of bomedemstat once daily for up to 10 years, with the starting dose as the same dose that the participant was on at the time of transition from the feeder study.
Treatment: Drugs: Bomedemstat
10, 15, 20, and 50 mg oral capsules
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of participants with one or more adverse events (AEs)
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Assessment method [1]
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An AE is any undesirable physical, psychological or behavioral effect experienced by a patient during participation in an investigational study, in conjunction with the use of the drug or biologic, whether or not product-related. This includes any untoward signs or symptoms experienced by the patient from the time of first dose with bomedemstat under this protocol until completion of the study. The percentage of participants with AEs will be presented.
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Timepoint [1]
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Up to ~10 years
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Primary outcome [2]
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Percentage of participants who discontinued study treatment due to an AE
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Assessment method [2]
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An AE is any undesirable physical, psychological or behavioral effect experienced by a patient during participation in an investigational study, in conjunction with the use of the drug or biologic, whether or not product-related. This includes any untoward signs or symptoms experienced by the patient from the time of first dose with bomedemstat under this protocol until completion of the study. The percentage of participants who discontinued study treatment due to an AE will be presented.
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Timepoint [2]
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Up to ~10 years
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Secondary outcome [1]
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For participants with ET or PV: Duration of clinicohematologic response
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Assessment method [1]
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For participants who showed durable clinicohematologic response (DCHR) in their feeder studies, duration of clinicohematologic response is defined as the time from the first documented evidence of confirmed reduction of platelet and white blood cell (WBC) count until confirmed increase of platelet and WBC counts to above acceptable threshold, thrombotic or major hemorrhagic events or disease progression to myelofibrosis (MF), myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML). The duration of clinicohematologic response will be reported.
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Timepoint [1]
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Up to ~10 years
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Secondary outcome [2]
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For participants with ET or PV: Duration of hematologic remission
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Assessment method [2]
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For participants who showed confirmed hematologic remission in their feeder studies, duration of hematologic remission is defined as the time from the first documented evidence of confirmed reduction of platelet and WBC count until confirmed increase of platelet and WBC counts to above acceptable threshold. The duration of hematologic remission will be reported.
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Timepoint [2]
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Up to ~10 years
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Secondary outcome [3]
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For participants with ET or PV: Percentage of participants with transformation to MF or MDS/AML
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Assessment method [3]
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Disease Progression is defined as the transformation to post-ET myelofibrosis (ET participants only), post-PV myelofibrosis (PV participants only), spleen volume increase =25% (MF participants only), myelodysplastic syndrome, or acute myeloid leukemia as assessed by the investigator. The percentage of participants with transformation to MF or MDS/AML will be reported.
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Timepoint [3]
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Up to ~10 years
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Secondary outcome [4]
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For participants with MF: Percentage of participants with worsening of splenomegaly or transformation to MDS/AML
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Assessment method [4]
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Spleen volume will be assessed by magnetic resonance imaging (MRI) (or computed tomography [CT] where applicable) at pre-specified timepoints. The percentage of participants with worsening of splenomegaly or transformation to MDS/AML will be reported.
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Timepoint [4]
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Up to ~10 years
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Secondary outcome [5]
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For participants with MF, ET, or PV: Percentage of participants with thrombotic events
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Assessment method [5]
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Thrombotic events are defined as: new or recurrent acute myocardial infarction; unstable angina; stroke; transient ischemic attack (TIA); deep venous thrombosis (DVT); pulmonary embolism (PE); thrombotic digital ischemia; other thrombotic events such as peripheral limb ischemia or Budd-Chiari syndrome that are assessed to be due to underlying PV; other vascular occlusive events such as symptoms of cardiac, abdominal or peripheral limb ischemia supported by objective evidence of vessel disease and/or ischemia. The percentage of participants with thrombotic events will be presented.
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Timepoint [5]
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Up to ~10 years
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Secondary outcome [6]
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For participants with MF, ET, or PV: Percentage of participants with major hemorrhagic events
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Assessment method [6]
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Hemorrhagic events are defined as: Major Bleeding (MB) Events such as fatal bleeding, and/or symptomatic bleeding in a critical area or organ such as intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome, and/or bleeding causing a fall in hemoglobin level of 2 g/dL or more, or leading to transfusion of 2 or more units of whole blood or red cells; Clinically Relevant Non-Major Bleeding (CRNMB) Events Leading to hospitalization or increased level of care or clinically important, prompting a face-to-face medical evaluation. The percentage of participants with major hemorrhagic events will be presented.
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Timepoint [6]
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Up to ~10 years
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Secondary outcome [7]
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For participants with MF, ET, or PV: Event-Free Survival (EFS)
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Assessment method [7]
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EFS is defined as the time from feeder study randomization (if randomized feeder study) or first dose (if nonrandomized feeder study) to the first documented occurrence of thrombotic or major hemorrhagic event or disease progression as assessed by the investigator, or death due to any cause, whichever occurs first. EFS will be reported.
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Timepoint [7]
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Up to ~10 years
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Eligibility
Key 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
- Be able to initiate study intervention on Day 1 of the extension study (ie, not
currently on a dose hold)
- Participant must be able to swallow oral medication and follow instructions for
at-home dosing of bomedemstat
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
23/05/2024
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
4/12/2034
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Actual
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Sample size
Target
400
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
SA
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Recruitment hospital [1]
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Royal Adelaide Hospital-Haematology Clinical Trials Unit ( Site 1000) - Adelaide
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Recruitment postcode(s) [1]
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5000 - Adelaide
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Auckland
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Merck Sharp & Dohme LLC
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT06351631
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Medical Director
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Address
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Merck Sharp and Dohme LLC
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Toll Free Number
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Address
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Country
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Phone
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1-888-577-8839
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT06351631
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