Myelodysplastic Syndrome Clinical Trial
Bomedemstat in Patients With Polycythemia Vera
Summary
This is a Phase 2 open label study of an orally administered LSD1 inhibitor, bomedemstat (IMG-7289), in patients with polycythemia vera.
This study investigates the following:
The safety and tolerability of bomedemstat
The pharmacodynamic effect of bomedemstat
Full Description
This is a Phase 2 multi-center, open-label study evaluating the safety, efficacy, pharmacokinetics and pharmacodynamics of bomedemstat administered orally once daily in patients with polycythemia vera.
Patients will receive 36 weeks of dosing and may qualify for additional treatment thereafter.
Patients will be followed closely throughout the study for both Adverse Events by frequent monitoring of clinical signs and symptoms as well as safety labs. Efficacy and pharmacodynamic effects will be closely monitored by frequent hematology assessments of peripheral blood. Throughout dosing, transfusions or phlebotomy may be administered if needed in accordance with standard institutional guidelines.
To ensure safety, a Safety Advisory Board will perform periodic reviews of safety parameters and pharmacodynamic markers.
Eligibility Criteria
Inclusion Criteria:
Diagnosis of Polycythemia Vera per World Health Organization (WHO) diagnostic criteria for myeloproliferative neoplasms
Bone marrow fibrosis score of Grade 0 or Grade 1
Patients that have failed at least one standard cytoreductive therapy to lower hematocrit
Platelet count ≥250 x 10ˆ9/L
Absolute neutrophil count (ANC) ≥1.5 x 10ˆ9/L
Life expectancy >36 weeks.
Must have discontinued prior cytoreductive therapy for 2 weeks (4 weeks for interferon) prior to study drug initiation.
Exclusion Criteria:
Eastern Cooperative Oncology Group (ECOG) performance status of 3 or greater
Unresolved treatment related toxicities from prior therapies (unless resolved to ≤ Grade 1).
Uncontrolled active infection.
Current use of prohibited medications
Known HIV infection or active Hepatitis B or Hepatitis C virus infection
Evidence of increased risk of bleeding, including known bleeding disorders
Other hematologic/biochemistry requirements, as per protocol
Pregnant or lactating females
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There is 1 Location for this study
Skokie Illinois, 60076, United States More Info
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