Bomedemstat for Polycythemia Vera

Recruiting at 20 trial locations

Overseen By Toll Free Number

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Imago BioSciences, Inc., a subsidiary of Merck & Co., Inc., (Rahway, New Jersey USA)

Disqualifiers: HIV, Hepatitis B/C, Bleeding disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 36 weeks

20 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a pill called bomedemstat for patients with polycythemia vera, a condition with too many red blood cells. The pill works by blocking an enzyme to reduce red blood cells and improve symptoms like an enlarged spleen.

Will I have to stop taking my current medications?

The trial requires that you stop taking any prior cytoreductive therapy for at least 2 weeks (4 weeks for interferon) before starting the study drug.

How does the drug bomedemstat differ from other treatments for polycythemia vera?

Bomedemstat is unique because it targets a different mechanism in the body compared to traditional treatments like interferon alpha or hydroxyurea, which are commonly used for polycythemia vera. While standard treatments focus on reducing blood cell production or managing symptoms, bomedemstat may offer a novel approach by potentially affecting the underlying disease process. ^{1 2 3 4 5}

Research Team

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Eligibility Criteria

This trial is for people with Polycythemia Vera who haven't responded well to at least one standard treatment. They should have a certain level of platelets and white blood cells, expect to live more than 36 weeks, and meet specific diagnostic criteria. Those with severe physical limitations, unresolved side effects from past treatments, certain infections or bleeding risks, pregnant or breastfeeding women, or on prohibited meds can't join.

Inclusion Criteria

My bone marrow fibrosis is minimal.

Has a life expectancy >36 weeks

I have tried at least one standard treatment to lower my blood volume without success.

Exclusion Criteria

I have HIV or active Hepatitis B/C.

I have an ongoing infection that isn't under control.

Is pregnant or lactating

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive bomedemstat daily for 36 weeks

36 weeks

Extended Treatment

Participants may receive additional treatment through Week 52 if deriving clinical benefit

16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• bomedemstat

Trial Overview The study tests Bomedemstat (MK-3543), an oral drug that targets LSD1 enzymes in patients with Polycythemia Vera. The goal is to see if it's safe and can manage the disease by reducing blood counts, improving symptoms, and shrinking enlarged spleens within 36 weeks.

Participant Groups

Group I: Bomedemstat Experimental Treatment 1 Intervention

Participants will receive bomedemstat daily for 36 weeks and may qualify for additional treatment through Week 52 if deriving clinical benefit.

Who Is Running the Clinical Trial?

Imago BioSciences, Inc., a subsidiary of Merck & Co., Inc., (Rahway, New Jersey USA)

Lead Sponsor

Trials

10

Recruited

380+

Imago BioSciences,Inc.

Lead Sponsor

Trials

10

Recruited

380+

Findings from Research

The expert panel recommends starting cytoreductive drug therapy for patients with polycythaemia vera under 60 years old if they meet specific criteria, such as severe symptoms or high blood cell counts, to improve their quality of life and reduce vascular risks.

Ropeginterferon alfa-2b and ruxolitinib are recommended treatments, with ropeginterferon being the preferred option for patients needing cytoreductive therapy, especially those intolerant to phlebotomy or with inadequate control of their condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Appropriate management of polycythaemia vera with cytoreductive drug therapy: European LeukemiaNet 2021 recommendations. Marchetti, M., Vannucchi, AM., Griesshammer, M., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

A remarkable hematological and molecular response pattern in a patient with polycythemia vera during combination therapy with simvastatin and alendronate. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Appropriate management of polycythaemia vera with cytoreductive drug therapy: European LeukemiaNet 2021 recommendations. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Polycythemia vera: scientific advances and current practice. [2012]

4. Austria pubmed.ncbi.nlm.nih.gov

Austrian recommendations for the management of polycythemia vera. [2019]

5. England pubmed.ncbi.nlm.nih.gov

A review of the therapeutic agents used in the management of polycythaemia vera. [2013]