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Epigenetic Modulator

Bomedemstat for Essential Thrombocythemia

Phase 3

Recruiting

Research Sponsored by Merck Sharp & Dohme LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Has an inadequate or loss of response to their most recent prior ET therapy, requiring a change of cytoreductive therapy

Has a diagnosis of ET per WHO 2016 diagnostic criteria for myeloproliferative neoplasms

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 180 weeks

Awards & highlights

Study Summary

This trial is testing a new drug called bomedemstat to see if it is better than the current best available treatment for patients with essential thrombocythemia who do not respond well to or

Who is the study for?

This trial is for individuals with essential thrombocythemia who haven't responded well to or can't tolerate hydroxyurea. They should have a life expectancy over one year, agree to contraception if they can father children, and not be pregnant or breastfeeding if female. A bone marrow fibrosis score of Grade 0 or 1 is required, along with certain blood cell count levels.Check my eligibility

What is being tested?

The study tests bomedemstat against the best available treatments like Busulfan and Ruxolitinib in patients with essential thrombocythemia. It aims to see if bomedemstat leads to better long-term control of blood cell counts compared to other options.See study design

What are the potential side effects?

Potential side effects may include those common to cancer therapies such as fatigue, digestive issues, changes in blood counts leading to increased infection risk or bleeding problems, liver function changes, and possible allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My last hormone therapy didn’t work, needing a new treatment.

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I have been diagnosed with essential thrombocythemia according to WHO standards.

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My bone marrow fibrosis is low grade.

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My white blood cell count is high enough for treatment.

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I have not responded well or had a bad reaction to hydroxyurea.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 180 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 180 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 180 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Durable Clinicohematologic Response (DCHR) Rate

Secondary outcome measures

Change From Baseline in Myelofibrosis Symptom Assessment Form (MFSAF) v4.0 Individual Fatigue Symptom Item Score

Change From Baseline in Patient-reported Outcomes Measurement Information System (PROMIS) Fatigue SF-7a Total Fatigue Score

Change From Baseline in Total Symptom Score as Measured on the MFSAF v4.0

+8 more

Side effects data

From 2022 Phase 1 & 2 trial • 90 Patients • NCT03136185

88%

Thrombocytopenia

63%

Nausea

50%

Oedema peripheral

38%

Pneumonia

38%

Diarrhoea

38%

Dysgeusia

25%

Pyrexia

25%

Pollakiuria

25%

Hot flush

25%

Fatigue

25%

Anaemia

25%

Constipation

25%

COVID-19

25%

Vomiting

25%

Hypoalbuminaemia

25%

Decreased appetite

25%

Muscular weakness

25%

Pain in extremity

25%

Myalgia

25%

Chronic obstructive pulmonary disease

25%

Epistaxis

25%

Hypotension

25%

Tachycardia

13%

Dry mouth

13%

Conjunctivitis

13%

Contusion

13%

Upper respiratory tract infection

13%

Cardiac murmur

13%

Hyperuricaemia

13%

Nephrolithiasis

13%

Pruritus

13%

Rash

13%

Small intestinal haemorrhage

13%

Rectal haemorrhage

13%

Influenza

13%

Neutropenia

13%

Septic shock

13%

Headache

13%

Dyspnoea

13%

Respiratory failure

13%

Ocular hyperaemia

13%

Bradycardia

13%

Lymphopenia

13%

Abdominal distension

13%

Abdominal pain

13%

Oral pain

13%

Erysipelas

13%

Fall

13%

Skin infection

13%

Blood alkaline phosphatase increased

13%

Activated partial thromboplastin time prolonged

13%

Parkinson's disease

13%

Blood lactate dehydrogenase increased

13%

Blood uric acid increased

13%

Blood sodium decreased

13%

Blood calcium decreased

13%

Blood potassium decreased

13%

Increased appetite

13%

Blood glucose increased

13%

Hypokalaemia

13%

Prothrombin time prolonged

13%

Hypophosphataemia

13%

Blood phosphorus decreased

13%

Weight decreased

13%

Paraesthesia

13%

Genital rash

13%

Muscle spasms

13%

Musculoskeletal pain

13%

Hypoxia

13%

Cough

13%

Rhinorrhoea

13%

Rash maculo-papular

13%

Decubitus ulcer

13%

Nail dystrophy

13%

Hypertension

100%

80%

60%

40%

20%

Study treatment Arm

Ph 2b PMF: Bomedemstat 0.5 mg/kg/d

Ph 1/2a PMF: Bomedemstat 0.25 mg/kg/d

Ph 2b PET-MF: Bomedemstat 0.6 mg/kg/d

Ph 1/2a PPV-MF: Bomedemstat 0.25 mg/kg/d

Ph 1/2a PET-MF: Bomedemstat 0.25 mg/kg/d

Ph 2b PET-MF: Bomedemstat 0.5 mg/kg/d

Ph 2b PPV-MF: Bomedemstat 0.5 mg/kg/d

Ph 2b PMF: Bomedemstat 0.6 mg/kg/d

Ph 2b PPV-MF: Bomedemstat 0.6 mg/kg/d

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: BomedemstatExperimental Treatment1 Intervention

Participants will begin treatment at a dose of 50 mg of bomedemstat daily. Dosage will be adjusted either up or down within specified time parameters for each participant to the dose that provides sufficient exposure to safely inhibit thrombopoiesis to decrease platelet counts to the target range. All participants will be treated daily for up to 52 weeks, and are eligible for an extended treatment phase up to 152 weeks.

Group II: Best Available TherapyActive Control4 Interventions

Each participant will receive either anagrelide, busulfan, interferon alfa/pegylated interferon alfa, or ruxolitinib as determined by investigator. All participants will be treated per respective approved product labels for up to 52 weeks. Participants receiving BAT for 52 weeks who stop responding to BAT are eligible to switch to bomedemstat and receive this for up to 152 weeks at the investigators discretion.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bomedemstat

2017

Completed Phase 2

~170

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCLead Sponsor

3,899 Previous Clinical Trials

5,062,562 Total Patients Enrolled

Medical DirectorStudy DirectorMerck Sharpe & Dohme LLC

2,783 Previous Clinical Trials

8,065,835 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the current investigation open for participant enrollment?

"As per details on clinicaltrials.gov, this research is currently in the recruitment phase. The study was first listed on December 31st, 2023 and was last modified on April 25th, 2024."

Answered by AI

Are multiple locations within the United States involved in conducting this research?

"The current trial is ongoing at 24 different sites, with key centers situated in Perth, Miyazaki, and Detroit. It's advisable to choose a location closer to you for convenience and reduced travel requirements upon enrollment."

Answered by AI

Has Bomedemstat received approval from the FDA?

"The safety rating for Bomedemstat is deemed to be 3 on the scale, reflecting the substantial evidence backing its efficacy and safety gathered through multiple rounds of data analysis during this Phase 3 trial."

Answered by AI

How many individuals are currently enrolled as participants in this clinical trial?

"Indeed, as per clinicaltrials.gov, this investigation is actively seeking suitable candidates. The trial was publicly accessible from 12/31/2023 and last amended on 4/25/2024. A total of 300 participants will be enrolled across 24 sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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)

2023. "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)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06079879.

All > Essential Thrombocythemia