PACIFICA Trial Study Design & Eligibility Criteria

Study Design

Chart

Trial Eligibility Criteria

  • Key Inclusion Criteria
    • Adults with primary or secondary MF
    • Platelet count <50,000/μL
    • DIPSS Int-1/-2 or High Risk
    • Palpable spleen ≥5cm
    • TSS ≥10 on the MPN-SAF v2.0
    • ECOG performance status 0-2
    • LVEF ≥50%
    • Peripheral blasts <10%
    • Adequate hepatic and renal function, coagulation parameters and neutrophil count
  • Key Inclusion Criteria
    • Prior splenectomy or aHSCT
    • Any MF therapy within 14 days
    • Prior treatment with more than one JAK2 inhibitor*
    • Grade ≥2 bleeding within prior 3 months unless caused by an event
    • Medications that increase bleeding risk within 14 days
    • Grade ≥2 cardiac conditions within 6 months
    • QTc ≥450ms or medicines that prolong QT within 14 days
    • NYHA Class II-IV heart failure
    • Active bowel disorders
    • Non-MF malignancy within 3 years

For full eligibility criteria visit:

ClinicalTrials.gov
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