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Small Molecule

IMG-7289 for Blood Cell Disorders

Phase 2
Recruiting
Research Sponsored by Terrence J Bradley, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Fibrosis score ≤ grade 2, as per a slightly modified version (Arber et al., 2016) of the European Consensus Criteria for Grading Myelofibrosis, (Thiele et al., 2005)
Age ≥ 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights

Study Summary

This trial will study the effects of IMG-7289 on blood cell counts in patients with essential thrombocythemia or polycythemia vera who have failed other treatments.

Who is the study for?
Adults diagnosed with Essential Thrombocythemia or Polycythemia Vera who haven't responded well to at least one standard treatment. Participants must have certain blood cell counts, agree to contraception, and be able to swallow capsules. Excluded are those with poor physical condition scores, pregnancy/breastfeeding plans, non-US residency, history of splenectomy, unresolved toxicities from past treatments, uncontrolled infections including HIV/hepatitis or bleeding risks.Check my eligibility
What is being tested?
The trial is testing IMG-7289's ability to control platelet, WBC or RBC levels in patients with ET or PV who've had inadequate responses to previous therapies. It involves regular monitoring through blood draws and bone marrow evaluations.See study design
What are the potential side effects?
Potential side effects aren't specified here but could include reactions similar to other drugs in the same class as IMG-7289 (LSD1 inhibitors), such as mood changes due to its chemical relation to MAOIs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My fibrosis score is 2 or less, based on a specific grading system.
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I am 18 years old or older.
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I am willing to undergo blood tests, spleen measurements, and bone marrow exams for the study.
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I have been diagnosed with Essential Thrombocythemia or Polycythemia Vera.
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I agree not to father a child or donate sperm for a month after my last dose.
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I stopped my previous treatment for this condition 2 weeks ago, or 4 weeks ago if it was interferon.
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I have tried at least one standard treatment without success or could not tolerate it.
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I can swallow pills.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Hematologic Response Rates
Secondary outcome measures
Change in Fibrosis Score
Change in Mutational Allele Burden
Change in Spleen Size in Centimeters
+2 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: IMG-7289 in ET and PV PatientsExperimental Treatment1 Intervention
Oral daily dose of 0.6 mg/kg/day IMG-7289 will be administered: The initial pilot period will enroll 8 participants to receive oral daily dose of IMG-7829 for 24 weeks, iteratively as long as there is clinical benefit in the absence of excess toxicity. The second stage group will enroll an additional 16 participants to receive IMG-7829 for over 2 years, iteratively as long as there is clinical benefit in the absence of toxicity.

Find a Location

Who is running the clinical trial?

Imago BioSciences,Inc.Industry Sponsor
9 Previous Clinical Trials
407 Total Patients Enrolled
Terrence J Bradley, MDLead Sponsor
1 Previous Clinical Trials
18 Total Patients Enrolled
Imago BioSciences, Inc., a subsidiary of Merck & Co., Inc., (Rahway, New Jersey USA)Industry Sponsor
9 Previous Clinical Trials
407 Total Patients Enrolled

Media Library

IMG-7289 (Small Molecule) Clinical Trial Eligibility Overview. Trial Name: NCT04262141 — Phase 2
Essential Thrombocythemia Research Study Groups: IMG-7289 in ET and PV Patients
Essential Thrombocythemia Clinical Trial 2023: IMG-7289 Highlights & Side Effects. Trial Name: NCT04262141 — Phase 2
IMG-7289 (Small Molecule) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04262141 — Phase 2

Frequently Asked Questions

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

Have there been any other experiments involving IMG-7289?

"Currently, 4 trials are underway to evaluate the efficacy of IMG-7289. None of them have progressed beyond Phase 3 yet. The majority of these experiments take place in Jena and Victoria, but there are 28 other research sites participating in this process too."

Answered by AI

How many people are participating in this clinical research?

"Affirmative. Clinicaltrials.gov reveals that this investigation, which was launched on October 2nd 2020, is actively recruiting patients. 24 individuals need to be recruited from 1 medical centre for the study's completion."

Answered by AI

Are there any available slots within this research trial for individuals to participate?

"According to clinicaltrials.gov, recruitment for this research endeavor is in full swing since it was first posted on October 2nd 2020 and revised on April 13th 2022."

Answered by AI

What risks have been identified with the use of IMG-7289?

"As this is only a Phase 2 trial, and no efficacy data exists yet, IMG-7289 has been assessed with a safety score of 2."

Answered by AI
~3 spots leftby Oct 2024