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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 : March 12, 2020
Sponsor:
Collaborator:
Imago BioSciences,Inc.
Information provided by (Responsible Party):
Robyn M Scherber, The University of Texas Health Science Center at San Antonio

Tracking Information
First Submitted Date  ICMJE September 4, 2019
First Posted Date  ICMJE September 9, 2019
Last Update Posted Date March 12, 2020
Estimated Study Start Date  ICMJE March 2020
Estimated Primary Completion Date January 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 6, 2019)
The proportion of patients who achieve complete hematologic remission [ Time Frame: 24 weeks using ELN (European Leukemia Net) criteria for ET (essential thrombocythemia) ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 4, 2019)
Determine the proportion of patients who achieve complete hematologic remission [ Time Frame: 24 weeks using ELN (European Leukemia Net) criteria for ET (essential thrombocythemia) ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Hematology, IMG-7289, LSD1 (Lysine-Specific Demethylase 1) Inhibitor, Essential Thrombocythemia (ET), Ph 2
Official Title  ICMJE An Investigator Initiated Phase 2 Trial of the LSD1 Inhibitor IMG-7289 in Essential Thrombocythemia (CTMS# 19-0078)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Thrombocythemia, Essential
Intervention  ICMJE Drug: IMG-7289
Single starting dose with individualized dose titrations throughout
Other Name: LSD1 inhibitor
Study Arms  ICMJE Experimental: IMG-7289
Intervention: Drug: IMG-7289
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: September 4, 2019)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2023
Estimated Primary Completion Date January 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Epp Goodwin 210-450-5798 goodwine@uthscsa.edu
Contact: Patricia Manea, BSN 210-450-1821 maneap@uthscsa.edu
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04081220
Other Study ID Numbers  ICMJE CTMS# 19-0078
HSC20190791H ( Other Identifier: UT Health Science Center San Antonio Institutional Review Board )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Robyn M Scherber, The University of Texas Health Science Center at San Antonio
Study Sponsor  ICMJE The University of Texas Health Science Center at San Antonio
Collaborators  ICMJE Imago BioSciences,Inc.
Investigators  ICMJE
Principal Investigator: Robyn Scherber, MD Mays Cancer Center
PRS Account The University of Texas Health Science Center at San Antonio
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP