Bomedemstat in Patients With Polycythemia Vera

• Status: Not yet recruiting
• Trial end date: 2024-07-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Imago BioSciences,Inc.

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