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LSD1 Inhibitor
IMG-7289 for Essential Thrombocythemia
Phase 2
Waitlist Available
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)
Must not have
Eastern Cooperative Oncology Group (ECOG) questionnaire score of 3 or greater
Greater than 3 separate transfusion episodes over the last 6 months and/or any transfusion over the last 4 weeks
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
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.
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.
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I need considerable assistance and am unable to carry out any work activities.
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I have had more than 3 blood transfusions in the last 6 months or any transfusion in the last 4 weeks.
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I have been diagnosed with Acquired Von Willebrand's disorder.
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I am currently taking MAOI medications.
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I do not have any untreated or uncontrolled infections.
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I have had my spleen removed.
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I have tested positive for HIV or hepatitis A, B, or C.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: IMG-7289Experimental Treatment1 Intervention
Find a Location
Who is running the clinical trial?
Imago BioSciences,Inc.Industry Sponsor
9 Previous Clinical Trials
374 Total Patients Enrolled
The University of Texas Health Science Center at San AntonioLead Sponsor
475 Previous Clinical Trials
92,307 Total Patients Enrolled
Imago BioSciences, Inc., a subsidiary of Merck & Co., Inc., (Rahway, New Jersey USA)Industry Sponsor
9 Previous Clinical Trials
374 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
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