Pacritinib in Combination With Low Dose Decitabine in Intermediate-High Risk Myelofibrosis or Myeloproliferative Neoplasm (MPN)/Myelodysplastic Syndrome (MDS)

Exclusion Criteria

• •Prior treatment with more than two JAK2 inhibitors or with pacritinib
• •Known positive status for human immunodeficiency virus (HIV)
• •Chronic, active, or acute viral hepatitis A, B, or C infection, or a hepatitis B or C carrier
• •Use of chemotherapy, biologic therapy, radiation therapy, erythropoietin or related erythropoiesis stimulating agents, or investigational therapy within 2 weeks of the first dose of study drug
• •History of allogeneic stem cell transplant or transplant eligible
• •Currently receiving any other investigational agents
• •History of allergic reactions attributed to compounds of similar chemical or biologic composition to pacritinib or other agents used in the study
• •Ongoing gastrointestinal medical condition such as Crohn's disease, inflammatory bowel disease, chronic diarrhea, or chronic constipation that could interfere with absorption of oral medication
• •Active bleeding that requires hospitalization during the screening period
• •Cardiovascular disease, including recent history of or currently clinically symptomatic and uncontrolled congestive heart failure, arrhythmia, angina, QTc prolongation or other QTc risk factors, myocardial infarction. Patients with CTCAE grade 2 cardiac arrhythmias may be considered for inclusion if the arrhythmias are stable, asymptomatic, and unlikely to affect patient safety. Patients will e excluded if they have ongoing cardiac dysrhythmias of CTCAE grade ≥ 3, corrected QT interval (QTc) prolongation \> 450 ms, or other factors that increase the risk for QT interval prolongation (e.g., heart failure, hypokalemia \[defined as serum potassium \< 3.0 mEq/L that is persistent and refractory to correction\], or family history of long QT interval syndrome).
• •Other malignancy requiring active treatment at time of study entry
• •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, or serious medical or psychiatric illness/social situations that would limit compliance with study requirements.
• •Life expectancy \< 6 months
• •Pregnant and/or breastfeeding. Patient must have a negative pregnancy test within 14 days of study entry.
• •Receiving treatment with any potent CYP3A4 inhibitors within 7 days of the first dose of study drug
• •Patients with MF who are eligible for enrollment in the pacritinib "PERSIST-2" study at WUSM (NCT02055781) HRPO 201406075.