SummaryThis is a randomised, controlled trial for people with Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post-essential Thrombocythemia Myelofibrosis, who have had no or limited exposure to any JAK2 inhibitor, or are JAK2 inhibitor-naive, and who have severe thrombocytopenia. Eligible participants will be randomly allocated to either the Experimental Arm or Active Comparator Arm. In the Experimental Arm, participants will receive pacritinib 200 mg twice daily (BID) orally, at the same time of day, with or without food. In the Active Comparator Arm, participants will receive the physician's choice of therapy (limited to single drugs from the following list: corticosteroids, hydroxyurea, danazol, or low-dose ruxolitinib). The proposed P/C regimen for a patient must be selected prior to randomization.
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A Randomized, Controlled Phase 3 Study of Pacritinib Versus Physician's Choice in Patients With Primary Myelofibrosis, Post Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis With Severe Thrombocytopenia (Platelet Count <50,000>50,000>