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Bomedemstat vs Best Available Therapy in Essential Thrombocythemia
NCT06079879Phase 3
Key facts
- Status
- Active, not recruiting
- Start
- Dec 2023
- Primary completion
- Jul 2027
- Countries
- 24
- Sponsor
- Merck & Co.
- Modality
- Small Molecules
- Drugs
- bomedemstat
- Conditions
- essential thrombocythemia (ET)
01
Overview
Phase 3, randomised, open-label trial of bomedemstat in essential thrombocythemia (ET) (2 arms), sponsored by Merck & Co. Primary endpoint: Durable Clinicohematologic Response Rate at 52 weeks. Started Dec 2023; status: active, not recruiting.
02
Design
2 arms- Study design
- RandomizedOpen-label
Bomedemstat
Bomedemstat 50 mg daily, dose adjusted to target platelet counts.
Best Available Therapy
Investigator's choice of anagrelide, busulfan, interferon alfa, or ruxolitinib.
03
Who it enrols
Participants must have a confirmed diagnosis of essential thrombocythemia, inadequate response or intolerance to hydroxyurea, platelet count > 450 x 10^9/L, and ANC >= 0.75 x 10^9/L. Excludes patients with increased bleeding risk, GI absorption issues, or recent malignancies.
04
Endpoints
Primary
Durable Clinicohematologic Response Rate
Secondary
Clinicohematologic Response Rate
Hematologic Response Rate
Change From Baseline in Patient-reported Outcomes Measurement Information System Fatigue SF-7a Total Fatigue Score
Change From Baseline in Total Symptom Score as Measured on the MFSAF v4.0
Duration of Durable Clinicohematologic Response
Duration of Clinicohematologic Response
Duration of Hematologic Response
Percentage of Participants with Thrombotic Events
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