Bomedemstat vs Hydroxyurea for Essential Thrombocythemia (MK-3543-007)

Conditions

• Essential Thrombocythemia

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Bomedemstat — DRUG
  Oral capsule
• Hydroxyurea — DRUG
  Oral capsule
• Bomedemstat placebo — DRUG
  Oral capsule placebo
• Hydroxyurea placebo — DRUG
  Oral capsule placebo

Study Details

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.

Key Dates

Start date

Jul 16, 2024

Status verified

Jun 2026

Primary completion

Sep 28, 2027

Completion

Mar 24, 2028

Study Design

Enrollment

300 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Bomedemstat
  Participants will receive active bomedemstat and hydroxyurea placebo daily for up to approximately 52 weeks. 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. Participants who complete treatment at Week 52 will be eligible to continue treatment in the extended treatment phase. Unblinding will occur and placebo discontinued once all participants have completed at least 52 weeks of therapy or otherwise discontinued.
• Active Comparator: Hydroxyurea
  Participants will receive active hydroxyurea and bomedemstat placebo daily for up to 52 weeks. 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. Participants who complete treatment at Week 52 will be eligible to continue treatment in the extended treatment phase. Unblinding will occur and placebo discontinued once all participants have completed at least 52 weeks of therapy or otherwise discontinued.

Primary Outcome Measure

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

Central Contacts

• Toll Free Number
  1-888-577-8839
  [email protected]

Locations (22)

Find similar trials in Glendale, AZ

Related Studies

• An Optimal Dose Finding Study of N-Acetylcysteine in Patients With Myeloproliferative Neoplasms
  PHASE1/PHASE2 · Recruiting · University of California, Irvine · Irvine, California
• Curcumin to Improve Inflammation and Symptoms in Patients With Clonal Cytopenia of Undetermined Significance, Low Risk Myelodysplastic Syndrome, and Myeloproliferative Neoplasms
  PHASE2 · Recruiting · University of Southern California · Los Angeles, California
• 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)
  PHASE3 · Recruiting · Merck Sharp & Dohme LLC · Glendale, Arizona
• Decitabine With Ruxolitinib, Fedratinib or Pacritinib for the Treatment of Accelerated/Blast Phase Myeloproliferative Neoplasms
  PHASE2 · Recruiting · University of Washington · Seattle, Washington