A Study of Bomedemstat (IMG-7289/MK-3543) Compared to Best Available Therapy (BAT) in Participants With Essential Thrombocythemia and an Inadequate Response or Intolerance of Hydroxyurea (MK-3543-006)
Condition(s) studied
Investigational drug(s) / intervention(s)
Bomedemstat: Oral Capsule
Anagrelide: Oral Capsule
Busulfan: Oral Tablet
Interferon alfa/pegylated interferon alfa 2a/pegylated interferon alfa 2b: Subcutaneous Solution
Ruxolitinib: Oral Tablet
Study summary
This is a study evaluating the safety and efficacy of bomedemstat (MK-3543) compared with the best available therapy (BAT) in participants with essential thrombocythemia (ET) who have an inadequate response to or are intolerant of hydroxyurea. The primary study hypothesis is that bomedemstat is superior to the best available therapy with respect to durable clinicohematologic response (DCHR).
Eligibility
Primary outcome measure(s)
- Durable Clinicohematologic Response (DCHR) Rate — Up to approximately 52 weeks
DCHR rate is the percentage of participants with DCHR, defined as a confirmed reduction of platelet count to ≤400 × 10\^9/L and absence of white blood cell (WBC) count elevation to \>10 × 10\^9/L locally assessed to be due to ET, starting by Week 24 and maintained for at least 24 weeks, and the absence of any thrombotic or major hemorrhagic events or disease progression to myelofibrosis (MF), myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) by Week 52.
Trial sites (161)
| Facility | City | Region | Status |
|---|---|---|---|
| Palo Verde Hematology/ Oncology Center, Ltd. ( Site 3496) | Glendale | Arizona | |
| Los Angeles Cancer Network ( Site 3491) | Glendale | California | |
| Stanford Cancer Institute ( Site 0107) | Stanford | California | |
| The Lundquist Institute ( Site 3423) | Torrance | California | |
| University of Colorado Anschutz Medical Campus ( Site 3425) | Aurora | Colorado | |
| Tufts Medical Center ( Site 3408) | Boston | Massachusetts | |
| University of Michigan ( Site 0008) | Ann Arbor | Michigan | |
| Henry Ford Hospital ( Site 3413) | Detroit | Michigan | |
| Optum Care Cancer Center ( Site 3497) | Las Vegas | Nevada | |
| Roswell Park Cancer Institute ( Site 3421) | Buffalo | New York | |
| Duke University Health System (DUHS) ( Site 0016) | Durham | North Carolina | |
| Wake Forest Baptist Health-Internal Medicine, Section on Hematology & Oncology ( Site 3400) | Winston-Salem | North Carolina | |
| Medical University of South Carolina-Hollings Cancer Center ( Site 3426) | Charleston | South Carolina | |
| University of Virginia ( Site 3422) | Charlottesville | Virginia | |
| VCU Health Adult Outpatient Pavillion ( Site 3416) | Richmond | Virginia | |
| Hospital Universitario Austral ( Site 0104) | Pilar | Buenos Aires | |
| Hospital Italiano de Buenos Aires ( Site 0105) | ABB | Buenos Aires F.D. | |
| C.I.C.E. 9 de Julio ( Site 1001) | San Miguel de Tucumán | Tucumán Province | |
| Royal Prince Alfred Hospital ( Site 1100) | Camperdown | New South Wales | |
| Liverpool Hospital-Haematology ( Site 0501) | Liverpool | New South Wales | |
| Royal North Shore Hospital ( Site 0003) | St Leonards | New South Wales | |
| Calvary Mater Newcastle ( Site 0505) | Waratah | New South Wales | |
| Royal Adelaide Hospital-Haematology Clinical Trials Unit ( Site 0001) | Adelaide | South Australia | |
| Monash Health-Haematology Research ( Site 0006) | Clayton | Victoria | |
| Western Health-Sunshine & Footscray Hospitals-Cancer Services-Cancer Research ( Site 0502) | Melbourne | Victoria | |
| Royal Perth Hospital-Haematology ( Site 0504) | Perth | Western Australia | |
| ZAS Cadix ( Site 1200) | Antwerp | Belgium | |
| The Moncton Hospital-Oncology ( Site 1500) | Moncton | New Brunswick | |
| The First Afflilated Hospital of Bengbu Medical College ( Site 3509) | Bengbu | Anhui | |
| Anhui Provincial Hospital ( Site 3513) | Hefei | Anhui | |
| Peking University Third Hospital-Hematology ( Site 3502) | Beijing | Beijing Municipality | |
| Peking Union Medical College Hospital ( Site 3531) | Beijing | Beijing Municipality | |
| The Second Affiliated Hospital Of Fujian Medical University ( Site 3525) | Quanzhou | Fujian | |
| The First Affiliated hospital of Xiamen University ( Site 3515) | Xiamen | Fujian | |
| Sun Yat-sen Memorial Hospital of Sun Yat-sen University ( Site 3524) | Guangzhou | Guangdong | |
| Southern Medical University Nanfang Hospital-Department of Hematopathology ( Site 3511) | Guangzhou | Guangdong | |
| The First Hospital of Hebei Medical University ( Site 3510) | Shijiazhuang | Hebei | |
| Henan Cancer Hospital-hematology department ( Site 3504) | Zhengzhou | Henan | |
| Wuhan Union Hospital ( Site 3500) | Wuhan | Hubei | |
| Jiangsu Province Hospital ( Site 3507) | Nanjing | Jiangsu |
+ 121 more sites — see the full list on the official registry below.
On this site
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Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06079879 on ClinicalTrials.gov ↗ ← All trials in Italy