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)
This is a study evaluating the safety and efficacy of bomedemstat (MK-3543) compared with the best available treatment (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 treatment with respect to durable clinicohematologic response (DCHR).
Stanford is currently not accepting patients for this trial.
Intervention(s):
- drug: Bomedemstat
- drug: Anagrelide
- drug: Busulfan
- drug: Interferon alfa/pegylated interferon alfa
- drug: Ruxolitinib
Eligibility
Inclusion Criteria:
- Has a diagnosis of ET per WHO 2016 diagnostic criteria for myeloproliferative
neoplasms
- Has a 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: hydroxyurea resistance (or inadequate response) or hydroxyurea
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 × 109/L (450k /μL) assessed up to 72 hours before first
dose of study intervention
- Has an absolute neutrophil count (ANC) ≥0.75 × 109/L assessed up to 72 hours before
first dose of study intervention
- Participants may have received up to 3 prior lines of therapy 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
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Leslie Hwang
lhwang1@stanford.edu
Not Recruiting
Our research team includes physicians, residents, medical students, research assistants, and volunteers. Our research topics include medical imaging, device validation, mobile application development, and pharmaceutical trials.
Some of the Neuro-Opthalmic concerns we investigate include Multiple Sclerosis, Optic Neuritis, IIH, and ICP.