Comparing bomedemstat to the best available therapy for essential thrombocythemia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the safety and efficacy of bomedemstat (MK-3543) in comparison to the best available therapy (BAT) for patients with essential thrombocythemia (ET) who have not responded adequately to or are intolerant of hydroxyurea. The primary hypothesis is that bomedemstat will demonstrate a superior durable clinicohematologic response (DCHR) compared to BAT. Participants will be monitored for their response to treatment and any adverse effects. The study aims to provide a new therapeutic option for patients struggling with existing treatments.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Has a diagnosis of ET per WHO 2016 diagnostic criteria for myeloproliferative neoplasms (confirmed by a central pathologist)
* 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 a history of inadequate response to or intolerance of hydroxyurea based on modified European LeukemiaNet (ELN) criteria for hydroxyurea resistance or intolerance
* Has an inadequate or loss of response to their most recent prior ET therapy, requiring a change of cytoreductive therapy
* Has a platelet count \> 450 × 10\^9/L (450k /μL) assessed up to 72 hours before first dose of study intervention
* Has an absolute neutrophil count (ANC) ≥0.75 × 10\^9/L assessed up to 72 hours before first dose of study intervention
* Participants may have received up to 3 prior ET-directed cytoreductive agents including hydroxyurea

Exclusion Criteria:

* Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to bomedemstat or lysine demethylase or monoamine oxidase inhibitor (LSDi or MAOi) or the chosen best available therapy (including anagrelide, interferon alfa/pegylated interferon, ruxolitinib, or busulfan) that contraindicates participation
* History of any illness/impairment of GI function that might interfere with drug absorption (eg, chronic diarrhea or history of gastric bypass surgical procedure), confound the study results or pose an additional risk to the individual by participation in the study
* Evidence at the time of Screening of increased risk of bleeding
* History of a malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years. Note: The time requirement does not apply to participants who underwent successful definitive resection of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ, excluding carcinoma in situ of the bladder
* Human immunodeficiency virus (HIV)-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease

Where it's running

• Palo Verde Hematology/ Oncology Center, Ltd. ( Site 3496)
  Glendale, Arizona, United States Recruiting
• Los Angeles Cancer Network ( Site 3491)
  Glendale, California, United States Recruiting
• Stanford Cancer Institute ( Site 0107)
  Stanford, California, United States Recruiting
• The Lundquist Institute ( Site 3423)
  Torrance, California, United States Recruiting
• University of Colorado Anschutz Medical Campus ( Site 3425)
  Aurora, Colorado, United States Recruiting
• Tufts Medical Center ( Site 3408)
  Boston, Massachusetts, United States Recruiting

+113 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Toll Free Number
• Email: Trialsites@msd.com
• Phone: 1-888-577-8839

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.