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)

Part of paid clinical trials in Glendale, Arizona.

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT06079879
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Essential Thrombocythemia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bomedemstat — DRUG
    Oral Capsule
  • Anagrelide — DRUG
    Oral Capsule
  • Busulfan — DRUG
    Oral Tablet
  • Interferon alfa/pegylated interferon alfa 2a/pegylated interferon alfa 2b — DRUG
    Subcutaneous Solution
  • Ruxolitinib — DRUG
    Oral Tablet

Study Details

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).

Key Dates

First listed
Oct 12, 2023
Start date
Dec 31, 2023
Status verified
Jul 2026
Primary completion
Jul 30, 2027
Completion
Aug 18, 2028

Study Design

Enrollment
340 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Bomedemstat
    Participants will begin treatment at a dose of 50 mg of bomedemstat daily. Dosage will be adjusted either up or down within specified time parameters for each participant to the dose that provides sufficient exposure to safely inhibit thrombopoiesis to decrease platelet counts to the target range. All participants will be treated daily for up to 52 weeks, and are eligible for an extended treatment phase up to 156 weeks.
  • Active Comparator: Best Available Therapy
    Each participant will receive either anagrelide, busulfan, interferon alfa/pegylated interferon alfa 2a/pegylated interferon alfa 2b, or ruxolitinib as determined by investigator. All participants will be treated per respective approved product labels for up to 52 weeks. Participants receiving BAT for 52 weeks who stop responding to BAT are eligible to switch to bomedemstat and receive this for up to 156 weeks at the investigators discretion.

Primary Outcome Measure

Durable Clinicohematologic Response (DCHR) Rate [ Time Frame: Up to approximately 52 weeks ]

Locations (16)

FacilityCityStateZIPSite coordinators
Palo Verde Hematology/ Oncology Center, Ltd. ( Site 3496)GlendaleArizona85304-
Los Angeles Cancer Network ( Site 3491)GlendaleCalifornia91206-
Stanford Cancer Institute ( Site 0107)StanfordCalifornia94305-5826-
The Lundquist Institute ( Site 3423)TorranceCalifornia90502-
University of Colorado Anschutz Medical Campus ( Site 3425)AuroraColorado80045-
Tufts Medical Center ( Site 3408)BostonMassachusetts02111-
University of Michigan ( Site 0008)Ann ArborMichigan48109-
Henry Ford Hospital ( Site 3413)DetroitMichigan48202-
Optum Care Cancer Center ( Site 3497)Las VegasNevada89102-
Roswell Park Cancer Institute ( Site 3421)BuffaloNew York14263-
Duke University Health System (DUHS) ( Site 0016)DurhamNorth Carolina27710-
Wake Forest Baptist Health-Internal Medicine, Section on Hematology & Oncology ( Site 3400)Winston-SalemNorth Carolina27157-
Oncology Associates of Oregon, P.C.(Willamette Valley Cancer Institute) (WVCI) ( Site 8000)EugeneOregon97401-
Medical University of South Carolina-Hollings Cancer Center ( Site 3426)CharlestonSouth Carolina29425-
University of Virginia ( Site 3422)CharlottesvilleVirginia22908-
VCU Health Adult Outpatient Pavillion ( Site 3416)RichmondVirginia23219-

Find similar trials in Glendale, AZ

By research site
Palo Verde Hematology/ Oncology Center, Ltd.· Glendale, AZLos Angeles Cancer Network· Glendale, CAStanford Cancer Institute· Stanford, CAThe Lundquist Institute· Torrance, CAUniversity of Colorado Anschutz Medical Campus· Aurora, COTufts Medical Center· Boston, MA

Related Studies