Hematology, IMG-7289, LSD1 (Lysine-Specific Demethylase 1) Inhibitor, Essential Thrombocythemia (ET), Ph 2
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.
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years and Over|
- - Age ≥18 years.
- - Diagnosis of Essential Thrombocythemia per World Health Organization (WHO) diagnostic criteria for myeloproliferative neoplasms (Arber et al.
- - 3.
- - 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.
- - 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.
- - If male, agrees not to donate sperm or father a child for at least one month after the last dose of the study medication.
- - 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.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|The University of Texas Health Science Center at San Antonio|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Ruben Mesa, MD|
|Principal Investigator Affiliation||Mays Cancer Center|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
Drug: - IMG-7289
Single starting dose with individualized dose titrations throughout
Contact a Trial Team
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Mays Cancer Center
San Antonio, Texas, 78229