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LSD1 Inhibitor
IMG-7289 for Essential Thrombocythemia
Phase 2
Recruiting
Led By Ruben Mesa, MD
Research Sponsored by The University of Texas Health Science Center at San Antonio
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Able to swallow capsules
Diagnosis of Essential Thrombocythemia per World Health Organization (WHO) diagnostic criteria for myeloproliferative neoplasms (Arber et al., 2016)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks using eln (european leukemia net) criteria for et (essential thrombocythemia)
Awards & highlights
Study Summary
This trial is testing a drug to see if it helps people with a blood disorder called essential thrombocythemia.
Who is the study for?
Adults diagnosed with Essential Thrombocythemia who have high platelet counts despite hydroxyurea treatment, can swallow capsules, and will use contraception. Excluded are those with unresolved toxicities from past treatments, active infections including HIV/hepatitis, bleeding risks, pregnancy/breastfeeding plans within six months or current breastfeeding.Check my eligibility
What is being tested?
The trial is testing the oral drug IMG-7289 for patients with Essential Thrombocythemia. It's an open-label study where all participants know they're receiving the medication to see how it affects their condition.See study design
What are the potential side effects?
Potential side effects of IMG-7289 aren't specified here but may include typical reactions to new medications such as digestive issues, fatigue, allergic reactions or changes in blood counts.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can swallow pills.
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I have been diagnosed with Essential Thrombocythemia according to WHO standards.
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I have had fevers related to my condition.
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I need treatment to lower my high platelet counts.
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I am 18 years old or older.
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I have leg ulcers or skin issues due to my medication.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 weeks using eln (european leukemia net) criteria for et (essential thrombocythemia)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks using eln (european leukemia net) criteria for et (essential thrombocythemia)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The proportion of patients who achieve complete hematologic remission
Trial Design
1Treatment groups
Experimental Treatment
Group I: IMG-7289Experimental Treatment1 Intervention
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Who is running the clinical trial?
Imago BioSciences,Inc.Industry Sponsor
9 Previous Clinical Trials
424 Total Patients Enrolled
The University of Texas Health Science Center at San AntonioLead Sponsor
452 Previous Clinical Trials
91,390 Total Patients Enrolled
Imago BioSciences, Inc., a subsidiary of Merck & Co., Inc., (Rahway, New Jersey USA)Industry Sponsor
9 Previous Clinical Trials
424 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can swallow pills.I agree not to father a child or donate sperm for a month after my last dose.I have been diagnosed with Essential Thrombocythemia according to WHO standards.I have had fevers related to my condition.I need considerable assistance and am unable to carry out any work activities.You are expected to live for more than 36 weeks.I have had more than 3 blood transfusions in the last 6 months or any transfusion in the last 4 weeks.You have signs that show you might have a higher chance of bleeding, such as:I am willing to undergo tests for spleen size, bone marrow, and blood during the study.My side effects from previous treatments are mild or gone.I cannot tolerate or my condition does not respond to hydroxyurea.I agree to use effective birth control during and up to 28 days after the study.I have been diagnosed with Acquired Von Willebrand's disorder.I am currently taking MAOI medications.I need treatment to lower my high platelet counts.I am 18 years old or older.I do not have any untreated or uncontrolled infections.I have had my spleen removed.I have tested positive for HIV or hepatitis A, B, or C.I have leg ulcers or skin issues due to my medication.I stopped my hormone therapy 2 weeks ago, or interferon 4 weeks ago.My platelet count is high even after taking medication for it.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Research Study Groups:
This trial has the following groups:- Group 1: IMG-7289
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could you provide a summary of past experiments conducted with IMG-7289?
"At present, 4 studies are being conducted with IMG-7289. Of those trials, none have reached phase 3 yet and they mainly take place in San Antonio, Texas. Nevertheless 28 sites globally are running clinicals for this medication."
Answered by AI
What is the current participant count of this clinical investigation?
"Affirmative. According to the clinicaltrials.gov portal, this research is still searching for volunteers; it was initially posted on April 9th 2020 and edited as recently as December 14th 2021. This investigation seeks 20 participants across a single medical facility."
Answered by AI
What have been the demonstrated effects of IMG-7289 on patient safety?
"IMG-7289's safety is rated a 2 due to the Phase 2 trial status, which implies that there have been some studies on its safety but no evidence of efficacy yet."
Answered by AI
Is this a pioneering clinical trial?
"Since 2020, Imago BioSciences Inc. has been conducting clinical trials on IMG-7289. The first one involved 20 participants and granted the drug its Phase 2 approval. Nowadays, 4 active studies are being conducted across 7 nations and 15 major cities."
Answered by AI
Are there currently any open enrollment opportunities for this research?
"Affirmative. According to the clinicaltrials.gov database, this research is currently recruiting volunteers. This project was initially posted on April 9th 2020 and has been recently updated December 14th 2021. The investigators of the study seek 20 participants from a single location."
Answered by AI
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