Bomedemstat vs Hydroxyurea for Essential Thrombocythemia (MK-3543-007)
ConditionEssential Thrombocythemia
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorMerck Sharp & Dohme LLC
About this trial
The purpose of this study is to evaluate the efficacy and safety of bomedemstat compared with hydroxyurea in cytoreductive therapy naïve essential thrombocythemia (ET) participants for whom cytoreductive therapy is indicated. Its primary objective is to compare bomedemstat to hydroxyurea with respect to durable clinicohematologic response (DCHR). The primary hypothesis is that bomedemstat is superior to hydroxyurea with respect to DCHR.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosis of Essential Thrombocythemia (ET) based on World Health Organization Criteria for myeloproliferative neoplasms, and an indication for cytoreductive therapy regardless of age or risk status
Has a centrally assessed bone marrow fibrosis score of Grade 0 or Grade 1, as per a modified version of the European Consensus Criteria for Grading Myelofibrosis
Has received no prior cytoreductive treatment for their ET
Human Immunodeficiency Virus (HIV)-infected participants have well controlled HIV on antiretroviral therapy
Disqualifiers
History of any illness/impairment of gastrointestinal function that might interfere with drug absorption
History of a malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years
HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
Has an active infection requiring systemic therapy
Trial design
Design model
Parallel
Treatments tested in this trial
Bomedemstat
DrugOral capsule
Hydroxyurea
DrugOral capsule
Bomedemstat placebo
DrugOral capsule placebo
Hydroxyurea placebo
DrugOral capsule placebo
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: BomedemstatExperimental treatment 2 interventions
Group B: HydroxyureaActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
Durable Clinicohematologic Response (DCHR) Rate
DCHR rate is the percentage of participants with DCHR, defined as a confirmed reduction of platelet count to ≤400 × 10\^9/L, 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.
Time frame
Up to Week 52Secondary outcomes
1
Change From Baseline in Myelofibrosis Symptom Assessment Form version 4.0 (MFSAF v4.0) Individual Fatigue Symptom Item Score
The MFSAF v4.0 is a 7-item participant-reported myelofibrosis symptom assessment which asks respondents to report symptom severity at its worst for each of the 7 items on a 0 (Absent) to 10 (Worst Imaginable) numeric rating scale.
Time frame
Baseline and pre-specified timepoints up to Week 522
Change From Baseline in Patient-reported Outcomes Measurement Information System (PROMIS) Fatigue SF-7a Total Fatigue Score
The PROMIS F SF-7a is a 7-item participant-reported assessment that measures both the experience of fatigue and the interference of fatigue on daily activities over the past week. Response options are on a 5-point Likert scale, ranging from 1 = never to 5 = always.
Time frame
Baseline and pre-specified timepoints up to Week 523
Change From Baseline in MFSAF v4.0 Total Symptom Score
The MFSAF v4.0 is a 7-item participant-reported myelofibrosis symptom assessment which asks respondents to report symptom severity at its worst for each of the 7 items on a 0 (Absent) to 10 (Worst Imaginable) numeric rating scale. The change from baseline in MFSAF total score for all symptoms will be presented.
Time frame
Baseline and Week 524
Duration of Hematologic Remission (DOHR)
For participants who demonstrate hematologic remission, DOHR is defined as the time from the first documented evidence of platelet and WBC counts reduction until platelet or WBC counts increase to above acceptable threshold.
Time frame
Up to Week 52Sponsors and contacts
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Source ClinicalTrials.gov