Phase 2 Study of Ruxolitinib in Idiopathic Hypereosinophilic Syndrome and Primary Eosinophilic Disorders
William Shomali
Summary
This phase II trial studies how well ruxolitinib works in treating patients with hypereosinophilic syndrome or primary eosinophilic disorders.
Description
PRIMARY OBJECTIVES: I. To determine the overall hematologic response rate to ruxolitinib in patients with hypereosinophilic syndrome and primary eosinophilic disorders. SECONDARY OBJECTIVES: I. To determine safety profile of ruxolitinib in patients with hypereosinophilic syndrome and primary eosinophilic disorders. II. To determine the proportion of patients on corticosteroids who are able to become corticosteroid-independent and/or reduce the dose by \>= 50%. III. To evaluate the duration of response (DoR). IV. To evaluate the time-to-response (TTR). V. To evaluate progression-free survi…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Subject with idiopathic hypereosinophilic syndrome must meet the following: * Has as at least 2 readings with an absolute eosinophil count \>= 1,500/mm\^3 in the preceding 3 months prior to starting ruxolitinib (one reading must be during the screening period). * Dependent, intolerant or refractory to corticosteroids OR has relapsed/refractory disease to other therapy besides corticosteroids. * Symptomatic from his/her disease OR has one or more signs of organ damage (assessed by the investigator as possibly-related to eosinophilia or biopsy-proven). This can incl…
Interventions
- DrugRuxolitinib
Given PO
Locations (4)
- Stanford Cancer Institute Palo AltoPalo Alto, California
- OHSU Knight Cancer InstitutePortland, Oregon
- University of UtahSalt Lake City, Utah
- Fred Hutchinson cancer research centerSeattle, Washington