IMG-7289 in Patients With Essential Thrombocythemia (ET) or Polycythemia Vera (PV) (NCT04262141) | Clinical Trial Compass
Active — Not RecruitingPhase 2
IMG-7289 in Patients With Essential Thrombocythemia (ET) or Polycythemia Vera (PV)
United States4 participantsStarted 2020-10-02
Plain-language summary
The purpose of this study is to assess the hematologic effects of IMG-7289 therapy in ET and PV patients who require platelet, White Blood Cell (WBC) or Red Blood Cell (RBC) control, and have failed at least one standard therapy.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age ≥ 18 years.
✓. Diagnosis of Essential Thrombocythemia or Polycythemia Vera per World Health Organization (WHO) diagnostic criteria for myeloproliferative neoplasms (Arber et al., 2016).
✓. Patients that have failed at least one standard therapy (failure is the equivalent of inadequate response or intolerance).
✓. Platelet count \>400 x 10\^9/L pre-dose Day 1for patients with essential thrombocytopenia.
✓. Platelet count \>150 x 10\^9/L pre-dose Day 1 for patients with polycythemia vera.
✓. Peripheral blast count \< 10% pre-dose Day 1.
✓. Absolute neutrophil count (ANC) ≥ 0.5 x 10\^9/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).
Exclusion criteria
✕. Eastern Cooperative Oncology Group (ECOG) questionnaire score of 3 or greater.
✕. Currently pregnant, planning on being pregnant in the following 6 months or currently breastfeeding.