This phase II trial studies how well ruxolitinib phosphate works in treating patients with hemophagocytic syndrome. Ruxolitinib phosphate may decrease secondary hemophagocytic syndrome by blocking some of the enzymes needed for cell growth.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02400463.
PRIMARY OBJECTIVES:
I. To assess the efficacy of ruxolitinib (ruxolitinib phosphate) 15 mg orally (PO) twice daily in patients with hemophagocytic syndrome (HPS).
SECONDARY OBJECTIVES:
I. To assess the safety and tolerability of ruxolitinib in patients with HPS.
II. To determine the response rate, duration of response, progression-free survival, and overall survival in ruxolitinib treated subjects.
III. To assess inflammatory cytokines and markers of T-cell/macrophage activation (i.e. cytokines, soluble interleukin-2 receptor [sIL-2R], soluble cluster of differentiation 163 [sCD163]) as predictive biomarkers.
OUTLINE:
Patients receive ruxolitinib phosphate PO twice daily (BID) on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days, then every 6-12 months thereafter.
Lead OrganizationUniversity of Michigan Rogel Cancer Center
Principal InvestigatorRyan Wilcox
