Clinical Trials /

Hematology, IMG-7289, LSD1 (Lysine-Specific Demethylase 1) Inhibitor, Essential Thrombocythemia (ET), Ph 2

NCT04081220

Description:

This is a single-center, open-label investigator-initiated trial evaluating the effects of IMG-7289 administered orally once daily in patients with essential thrombocythemia.

Related Conditions:
  • Essential Thrombocythemia
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Hematology, IMG-7289, LSD1 (Lysine-Specific Demethylase 1) Inhibitor, Essential Thrombocythemia (ET), Ph 2
  • Official Title: An Investigator Initiated Phase 2 Trial of the LSD1 Inhibitor IMG-7289 in Essential Thrombocythemia (CTMS# 19-0078)

Clinical Trial IDs

  • ORG STUDY ID: CTMS# 19-0078
  • SECONDARY ID: HSC20190791H
  • NCT ID: NCT04081220

Conditions

  • Thrombocythemia, Essential

Interventions

DrugSynonymsArms
IMG-7289LSD1 inhibitorIMG-7289

Purpose

This is a single-center, open-label investigator-initiated trial evaluating the effects of IMG-7289 administered orally once daily in patients with essential thrombocythemia.

Trial Arms

NameTypeDescriptionInterventions
IMG-7289Experimental
  • IMG-7289

Eligibility Criteria

        Inclusion Criteria:

          -  Age ≥18 years.

          -  Diagnosis of Essential Thrombocythemia per World Health Organization (WHO) diagnostic
             criteria for myeloproliferative neoplasms (Arber et al., 2016).

          -  3. Patients who are intolerant or resistant to hydroxyurea per ELN (European Leukemia
             Net) criteria, or in the Investigator's judgment are not candidates for available
             approved therapy. The ELN definitions of resistance/intolerance to HU (hydroxyurea)
             requires the fulfillment of at least one of the following criteria:

               -  Platelet count greater than 600 × 109/L after 3 months of at least 2 g/day of HU
                  (2.5 g/day in patients with a body weight over 80 kg);

               -  Platelet count greater than 400 × 109/L and leukocytes less than 2.5 × 109/L or
                  hemoglobin (Hb) less than 100 g/L at any dose of HU;

               -  Presence of leg ulcers or other unacceptable mucocutaneous manifestations at any
                  dose of HU;

               -  HU-related fever.

          -  Requires treatment in order to lower platelet counts based on the Clinically Relevant
             IPSET (International Prognostic Score for Thrombosis in Essential Thrombocythemia)
             -Thrombosis Guidelines.

          -  Platelet count >450 x 109/L pre-dose Day 1.

          -  Peripheral blast count <10% pre-dose Day 1.

          -  ANC (absolute neutrophil count) ≥0.5 x 109/L pre-dose Day 1.

          -  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).

          -  Life expectancy > 36 weeks.

          -  Able to swallow capsules.

          -  Amenable to spleen size determination, bone marrow evaluations, and peripheral blood
             sampling during the study.

          -  Must have discontinued ET therapy at least 2 weeks (4 weeks for interferon) prior to
             study drug initiation.

          -  Agrees to use an approved method of contraception from Screening until 28 days after
             last administration of the study drug. Acceptable methods of birth control include:
             birth control pills, depo-progesterone injections, a vaginal hormonal contraceptive
             ring, a barrier contraceptive such as a condom with spermicide cream or gel,
             diaphragms or cervical cap with spermicide cream or gel, or an intrauterine device
             (IUD).

          -  If male, agrees not to donate sperm or father a child for at least one month after the
             last dose of the study medication.

        Exclusion Criteria:

          -  Greater than 3 separate transfusion episodes over the last 6 months and/or any
             transfusion over the last 4 weeks.

          -  Eastern Cooperative Oncology Group (ECOG) questionnaire score of 3 or greater.

          -  Currently pregnant or planning on being pregnant in the following 6 months or
             currently breastfeeding.

          -  Currently residing outside the United States.

          -  History of splenectomy.

          -  Unresolved treatment related toxicities from prior therapies (unless resolved to ≤
             Grade 1).

          -  Uncontrolled active infection.

          -  Known positive for HIV or infectious hepatitis, type A, B or C.

          -  Current use of monoamine oxidase A and B inhibitors (MAOIs).

          -  Evidence at the time of screening of increased risk of bleeding, including any of the
             following:

               1. Activated partial thromboplastin time (aPTT) > 1.3 x the upper limit of normal

               2. International normalized ratio (INR) >1.3 x the local upper limit of normal

               3. Known Acquired Von Willebrand's disorder.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:The proportion of patients who achieve complete hematologic remission
Time Frame:24 weeks using ELN (European Leukemia Net) criteria for ET (essential thrombocythemia)
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:The University of Texas Health Science Center at San Antonio

Last Updated

June 8, 2020