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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
400
10, 15, 20, and 50 mg oral capsules
University of Michigan ( Site 6000)
Ann Arbor, Michigan, United States
RECRUITINGDUHS Duke Blood Cancer Center ( Site 6005)
Durham, North Carolina, United States
RECRUITINGThe James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C ( Site 6007)
Columbus, Ohio, United States
RECRUITINGUPMC Hillman Cancer Center ( Site 6004)
Pittsburgh, Pennsylvania, United States
Percentage of participants with one or more adverse events (AEs)
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.
Time frame: Up to ~10 years
Percentage of participants who discontinued study treatment due to an AE
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.
Time frame: Up to ~10 years
For participants with ET or PV: Duration of clinicohematologic response
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.
Time frame: Up to ~10 years
For participants with ET or PV: Duration of hematologic remission
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.
Time frame: Up to ~10 years
For participants with ET or PV: Percentage of participants with transformation to MF or MDS/AML
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.
Time frame: Up to ~10 years
For participants with MF: Percentage of participants with worsening of splenomegaly or transformation to MDS/AML
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.
Time frame: Up to ~10 years
For participants with MF, ET, or PV: Percentage of participants with thrombotic events
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.
Time frame: Up to ~10 years
For participants with MF, ET, or PV: Percentage of participants with major hemorrhagic events
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.
Time frame: Up to ~10 years
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Royal Prince Alfred Hospital ( Site 1003)
Camperdown, New South Wales, Australia
RECRUITINGRoyal North Shore Hospital ( Site 1001)
St Leonards, New South Wales, Australia
RECRUITINGSunshine Coast Hematology and Oncology Clinic ( Site 1006)
Buderim, Queensland, Australia
RECRUITINGGold Coast University Hospital-Cancer and Blood Disorders Clinical Trial Team ( Site 1002)
Southport, Queensland, Australia
RECRUITINGRoyal Adelaide Hospital-Haematology Clinical Trials Unit ( Site 1000)
Adelaide, South Australia, Australia
RECRUITINGMonash Health ( Site 1004)
Clayton, Victoria, Australia
RECRUITING...and 11 more locations