Health Trials

Ruxolitinib in Treating Patients With Hypereosinophilic Syndrome or Primary Eosinophilic Disorders

ConditionsBCR-JAK2 Fusion Protein ExpressionBlasts 20 Percent or Less of Peripheral Blood White CellsBlasts More Than 5 Percent of Bone Marrow Nucleated CellsBlasts More Than 5 Percent of Peripheral Blood White CellsBlasts Under 20 Percent of Bone Marrow Nucleated CellsChronic Eosinophilic Leukemia, Not Otherwise SpecifiedEosinophiliaHepatomegalyHypereosinophilic SyndromeJAK2 Gene MutationSplenomegalyTEL-JAK2 Fusion Protein Expression
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorWilliam Shomali

About this trial

This phase II trial studies how well ruxolitinib works in treating patients with hypereosinophilic syndrome or primary eosinophilic disorders.

Eligibility criteria

Qualifiers

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 include skin, lung, cardiac, central nervous system, liver, or gastrointestinal (GI) involvement, or evidence of symptomatic hepatic or splenic enlargement.

Subject with lymphocyte-variant hypereosinophilia must meet the following

Disqualifiers

Active life-threatening complication(s) from underlying eosinophilic disease (i.e., leukostasis; acute thromboembolic disease including central nervous system (CNS) involvement; severe pulmonary or cardiac dysfunction). Stabilization of acute, life-threatening eosinophil-related co-morbidities will allow enrollment of the patient.

World Health Organization (WHO)-defined myeloid neoplasm associated with eosinophilia other than CEL NOS and JAK2 rearranged neoplasms (e.g., myelodysplastic syndrome (MDS); myeloproliferative neoplasms (MPN); MDS/MPN overlap disorders; and systemic mastocytosis (SM).

Reactive hypereosinophilia due to connective tissue disease, sarcoidosis or eosinophilic granulomatosis with polyangiitis.

Organ-restricted ?tissue? eosinophilia with the absence of peripheral eosinophilia in the blood.

Trial design

Treatments tested in this trial

  • Ruxolitinib

Treatment groups

10 Participants
are divided into 1 treatment group

Locations

4
Stanford Cancer Institute Palo Alto94304, Palo AltoCalifornia, United States
OHSU Knight Cancer Institute97201, PortlandOregon, United States
University of Utah84112, Salt Lake CityUtah, United States
Fred Hutchinson cancer research center98109, SeattleWashington, United States

Sponsors and collaborators

William Shomali

Lead sponsor

Stanford University

Sponsor institution

Incyte Corporation

Collaborator

Source ClinicalTrials.gov