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

Sponsor

The University of Texas Health Science Center at San Antonio (Other)

Overall Status

Recruiting

CT.gov ID

NCT04081220

Collaborator

Imago BioSciences,Inc. (Industry)

Enrollment

Location

Arm

44.7

Anticipated Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

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)

Actual Study Start Date :

Apr 9, 2020

Anticipated Primary Completion Date :

Jan 1, 2023

Anticipated Study Completion Date :

Jan 1, 2024

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: IMG-7289

Drug: IMG-7289

Single starting dose with individualized dose titrations throughout

Other Names:

LSD1 inhibitor

Outcome Measures

Primary Outcome Measures

The proportion of patients who achieve complete hematologic remission [24 weeks using ELN (European Leukemia Net) criteria for ET (essential thrombocythemia)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age ≥18 years.
Diagnosis of Essential Thrombocythemia per World Health Organization (WHO) diagnostic criteria for myeloproliferative neoplasms (Arber et al., 2016).
1. 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:

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
Known Acquired Von Willebrand's disorder.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mays Cancer Center	San Antonio	Texas	United States	78229

Sponsors and Collaborators

The University of Texas Health Science Center at San Antonio
Imago BioSciences,Inc.

Investigators

Principal Investigator: Ruben Mesa, MD, Mays Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ruben Mesa, Clinical Investigator, The University of Texas Health Science Center at San Antonio

ClinicalTrials.gov Identifier:

NCT04081220

Other Study ID Numbers:

CTMS# 19-0078
HSC20190791H

First Posted:

Sep 9, 2019

Last Update Posted:

Dec 15, 2021

Last Verified:

Dec 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Thrombocytosis

Thrombocythemia, Essential

Study Results

No Results Posted as of Dec 15, 2021