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.
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)
Prior treatment with Janus kinase (JAK) inhibitors
Prior treatment with selinexor or other Exportin 1 (XPO1) inhibitors
Treatment with any MF-directed therapy (including investigational therapies and excluding hydroxyurea) within 2 weeks or 5.5 half-lives, whichever is shorter, of Cycle 1 Day 1
Completed hematopoietic cell transplant (HCT)
John Mascarenhas
Lead sponsor
Icahn School of Medicine at Mount Sinai
Sponsor institution
Sobi, Inc.
Collaborator
Karyopharm Therapeutics Inc
Collaborator
National Cancer Institute (NCI)
Collaborator