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

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ClinicalTrials.gov Identifier: NCT04081220
Recruitment Status : Not yet recruiting
First Posted : September 9, 2019
Last Update Posted : November 22, 2019
Sponsor:
Collaborator:
Imago BioSciences,Inc.
Information provided by (Responsible Party):
Robyn M Scherber, The University of Texas Health Science Center at San Antonio

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Thrombocythemia, Essential Drug: IMG-7289 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Investigator Initiated Phase 2 Trial of the LSD1 Inhibitor IMG-7289 in Essential Thrombocythemia (CTMS# 19-0078)
Estimated Study Start Date : January 31, 2020
Estimated Primary Completion Date : January 31, 2022
Estimated Study Completion Date : December 2023


Arm Intervention/treatment
Experimental: IMG-7289 Drug: IMG-7289
Single starting dose with individualized dose titrations throughout
Other Name: LSD1 inhibitor




Primary Outcome Measures :
  1. The proportion of patients who achieve complete hematologic remission [ Time Frame: 24 weeks using ELN (European Leukemia Net) criteria for ET (essential thrombocythemia) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04081220


Contacts
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Contact: Epp Goodwin 210-450-5798 goodwine@uthscsa.edu
Contact: Patricia Manea, BSN 210-450-1821 maneap@uthscsa.edu

Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
Imago BioSciences,Inc.
Investigators
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Principal Investigator: Robyn Scherber, MD Mays Cancer Center

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Responsible Party: Robyn M Scherber, Clinical Investigator, The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT04081220    
Other Study ID Numbers: CTMS# 19-0078
HSC20190791H ( Other Identifier: UT Health Science Center San Antonio Institutional Review Board )
First Posted: September 9, 2019    Key Record Dates
Last Update Posted: November 22, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Thrombocytosis
Thrombocythemia, Essential
Blood Platelet Disorders
Hematologic Diseases
Myeloproliferative Disorders
Bone Marrow Diseases
Blood Coagulation Disorders
Hemorrhagic Disorders