← Back to Search

Small Molecule

IMG-7289 for Blood Cell Disorders

Phase 2

Waitlist Available

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

Must not have

Uncontrolled active infection

Evidence at the time of screening of increased risk of bleeding, including any of the following: Activated partial thromboplastin time (aPTT) > 1.3 x the upper limit of normal, International normalized ratio (INR) >1.3 x the local upper limit of normal, History of severe thrombocytopenia or platelet dysfunction unrelated to a myeloproliferative disorder or its treatment, Known bleeding disorder (e.g., dysfibrinogenaemia, factor IX deficiency, haemophilia, Von Willebrand's disorder, Disseminated Intravascular Coagulation [DIC], fibrinogen deficiency, or other clotting factor deficiency)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

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.

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.

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

Select...

My fibrosis score is 2 or less, based on a specific grading system.

Select...

I am 18 years old or older.

Select...

I have been diagnosed with Essential Thrombocythemia or Polycythemia Vera.

Select...

I agree not to father a child or donate sperm for a month after my last dose.

Select...

I can swallow pills.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I do not have any ongoing infections that aren't responding to treatment.

Select...

I have a higher risk of bleeding due to blood test results or a history of bleeding disorders.

Select...

I am not allergic to IMG-7289, LSD1 inhibitors, or similar drugs.

Select...

I have had my spleen removed.

Select...

My kidney or liver function is not significantly impaired.

Select...

I need considerable assistance and am unable to carry out any work activities.

Select...

I am not taking, nor will I need, any medication that is not allowed during the trial.

Select...

I am unable to make medical decisions for myself.

Select...

I am currently taking MAOI medications.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Hematologic Response Rates

Secondary study objectives

Change in Fibrosis Score

Change in Mutational Allele Burden

Change in Spleen Size in Centimeters

+2 more

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-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.

0 / 14Eligibility criteria met