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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-506996-89-00 | Registry Identifier | EU CT | |
| U1111-1294-8621 | Registry Identifier | UTN | |
| MK-3543-017 | Other Identifier | MSD |
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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:
No hypothesis testing will be conducted in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bomedemstat | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bomedemstat | Drug | 10, 15, 20, and 50 mg oral capsules |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Up to ~10 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Toll Free Number | Contact | 1-888-577-8839 | Trialsites@msd.com |
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp and Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan ( Site 6000) | Recruiting | Ann Arbor | Michigan | 48109 | United States |
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
| Plain Language Summary | View source |
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| 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. | 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. | 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. | 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. | 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. | Up to ~10 years |
| DUHS Duke Blood Cancer Center ( Site 6005) | Recruiting | Durham | North Carolina | 27705 | United States |
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| The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C ( Site 6007) | Recruiting | Columbus | Ohio | 43210 | United States |
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| UPMC Hillman Cancer Center ( Site 6004) | Recruiting | Pittsburgh | Pennsylvania | 15232 | United States |
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| Royal Prince Alfred Hospital ( Site 1003) | Recruiting | Camperdown | New South Wales | 2050 | Australia |
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| Royal North Shore Hospital ( Site 1001) | Recruiting | St Leonards | New South Wales | 2065 | Australia |
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| Sunshine Coast Hematology and Oncology Clinic ( Site 1006) | Recruiting | Buderim | Queensland | 4556 | Australia |
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| Gold Coast University Hospital-Cancer and Blood Disorders Clinical Trial Team ( Site 1002) | Recruiting | Southport | Queensland | 4215 | Australia |
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| Royal Adelaide Hospital-Haematology Clinical Trials Unit ( Site 1000) | Recruiting | Adelaide | South Australia | 5000 | Australia |
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| Monash Health ( Site 1004) | Recruiting | Clayton | Victoria | 3168 | Australia |
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| Queen Mary Hospital ( Site 1601) | Active, not recruiting | Hksar | Hong Kong |
| Azienda Ospedaliera Universitaria Careggi ( Site 2700) | Recruiting | Florence | Tuscany | 50134 | Italy |
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| Azienda Ospedaliero-Universitaria SS. Antonio e Biagio e Cesare Arrigo ( Site 2703) | Recruiting | Alessandria | 15121 | Italy |
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| IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola ( Site 2702) | Recruiting | Bologna | 40138 | Italy |
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| Ospedale di Circolo e Fondazione Macchi Varese ( Site 2701) | Recruiting | Varese | 21100 | Italy |
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| North Shore Hospital-Department of Haematology ( Site 1401) | Active, not recruiting | Auckland | 0622 | New Zealand |
| Aotearoa Clinical Trials ( Site 1400) | Active, not recruiting | Auckland | 2025 | New Zealand |
| Imperial College Healthcare NHS Trust - Hammersmith Hospital ( Site 3402) | Recruiting | London | Hammersmith and Fulham | W12 0HS | United Kingdom |
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| Boston Pilgrim Hospital ( Site 3403) | Recruiting | Boston | Lincolnshire | PE21 9QS | United Kingdom |
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| University College London Hospital ( Site 3400) | Recruiting | London | London, City of | NW1 2PG | United Kingdom |
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| Guy's & St Thomas' NHS Foundation Trust ( Site 3401) | Recruiting | London | London, City of | SE1 9RT | United Kingdom |
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| ID | Term |
|---|---|
| D013920 | Thrombocythemia, Essential |
| D055728 | Primary Myelofibrosis |
| D011087 | Polycythemia Vera |
| ID | Term |
|---|---|
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D013922 | Thrombocytosis |
| D001791 | Blood Platelet Disorders |
| D009196 | Myeloproliferative Disorders |
| D001855 | Bone Marrow Diseases |
| D006474 | Hemorrhagic Disorders |
| D019046 | Bone Marrow Neoplasms |
| D019337 | Hematologic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000730033 | bomedemstat |
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