Selinexor and Pacritinib in JAK Inhibitor-naïve MF Patients With Cytopenias (NCT07447817) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Selinexor and Pacritinib in JAK Inhibitor-naïve MF Patients With Cytopenias
United States26 participantsStarted 2026-05-04
Plain-language summary
This is a phase II, multicenter, open-label trial evaluating the safety and efficacy of pacritinib and selinexor in JAK inhibitor naïve patients with anemia and thrombocytopenia.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Adults ≥ 18 years of age capable of providing informed consent
* Pathologically confirmed diagnosis of PMF, post-ET MF, or post-PV MF as per the World Health Organization (WHO) diagnostic criteria - Intermediate-1, Intermediate-2, or High-Risk disease by the Dynamic International Prognostic Scoring System (DIPSS)
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
* Baseline splenomegaly ≥ 5cm palpable below the left costal margin and in the midclavicular line OR ≥ 450cc by imaging (i.e. ultrasound, CT, MRI)
* Baseline anemia, defined by hemoglobin \< 10 g/dL within 28 days prior to Cycle 1 Day 1
* Baseline thrombocytopenia, defined by platelet count 50-150 x 109/L without platelet transfusions within 28 days prior to Cycle 1 Day 1
* Adequate organ function as demonstrated by the following within 28 days prior to Cycle 1 Day 1:
* ALT (SGPT) and/or AST (SGOT) ≤ 3x the upper limit of normal (ULN), or ≤ 4 x ULN if, upon judgment of the treating physician, it is believed to be due to MF-related extramedullary hematopoiesis (EMH);
* Direct bilirubin ≤ 1.5 x ULN; or ≤ 2x ULN if, upon judgment of the treating physician, it is believed to be due to MF-related extramedullary hematopoiesis (EMH) or documented Gilbert's syndrome;
* Creatinine clearance ≥ 30 mL/min;
* Prothrombin time (PT) and activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN (Exceptions to coagulation parameters may be considered for patients who are taking concomita…