Pacritinib in Relapsed/Refractory Lymphoproliferative Disorders

Exclusion Criteria

• •History of, or a concurrent, clinically significant illness, medical condition or laboratory abnormality that, in the investigator's opinion, could affect the conduct of the study
• •Pregnant or breast feeding women
• •Unwilling or unable to use a medically acceptable form of contraception during the time of participation in the trial (sexual abstinence is permissible) unless documented successful vasectomy, hysterectomy, bilateral oophorectomy or post-menopausal for at least 2 years
• •Uncontrolled current illness, including, but not limited to the following: Ongoing or active infections requiring intravenous antimicrobials; symptomatic congestive heart failure defined as NYHA class II, III or IV (Appendix II); unstable angina pectoris within 6 months of study enrollment; unstable cardiac arrhythmia; history of myocardial infarction, stroke or intracranial hemorrhage within 6 months prior to enrollment; moderate to severe hepatic impairment (Child-Pugh class B or C); psychiatric illness or social situations that would limit compliance with study requirements
• •Known HIV infection
• •Known positive Hepatitis B surface antigen or Hep C virus
• •Recent (within 21 days of initiation of therapy, day 1) major surgery
• •Less than 14 days have elapsed since last radiation therapy or chemotherapy treatment or patient has not recovered from all clinically significant treatment-related toxicity; less than 90 days have passed since date of autologous stem cell transplant and patient has not recovered to ≤grade 1 toxicity related to this procedure
• •Use of systemic steroids (oral, inhaled, nasal, topical) at a dose less \> 10 mg/day of prednisone
• •Prior treatment with pacritinib
• •Uncontrolled autoimmune hemolytic anemia (AIHA) or autoimmune thrombocytopenia (ITP). Coombs positivity in absence of hemolysis is not an exclusion.
• •Requires anticoagulation with heparin, warfarin or equivalent Vit K antagonist
• •History of significant bleeding (≥Grade 2 by CTCAE) history or complications (including bleeding that may have occurred while on ibrutinib)
• •Hypersensitivity or allergic reaction to compounds related to pacritinib
• •Treatment with potent CYP450 inducers and strong CYP3A4 inhibitors for which no alternative is available; treatment with strong CYP450 inducers or strong CYP3A4 inhibitors within 2 weeks of initiation of therapy, day 1
• •Concurrent administration of QTc prolonging agents; significant QTc prolonging agents must be stopped within 5 half-lives of day 1.
• •Any gastrointestinal or metabolic condition that could interfere with the absorption of oral medication