Phase 2 Study of Ruxolitinib in Idiopathic Hypereosinophilic Syndrome and Primary Eosinophilic Disorders

Who is this study for? Patients with hypereosinophilic syndrome and primary eosinophilic disorders
What treatments are being studied? Ruxolitinib
Status: Recruiting
Location: See all (4) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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 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

‣ Has 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 GI involvement, or evidence of symptomatic hepatic or splenic enlargement

⁃ Has abnormal T-lymphocyte immuno-phenotype by flow cytometry.

• Subject with chronic eosinophilic leukemia, not otherwise specified (CEL,NOS) must meet the following

‣ Has at least 2 readings with an absolute eosinophil count \>= 500/mm\^3 in the preceding 3 months prior to starting ruxolitinib (one reading must be during the screening period).

⁃ Newly-diagnosed OR receiving corticosteroids OR has relapsed/refractory disease to any therapy besides corticosteroids.

⁃ Has increased blasts in the blood or bone marrow (\> 5% and \< 20%), and/or a clonal cytogenetic or molecular abnormality

∙ Subjects with JAK2 mutations are included within this group.

• Subject with JAK2-rearranged eosinophilic neoplasm must meet the following

‣ Has at least 2 readings with an absolute eosinophil count \>= 500/mm\^3 in the preceding 3 months prior to starting ruxolitinib (one reading must be during the screening period).

⁃ Newly-diagnosed OR receiving corticosteroids OR has relapsed/refractory disease to any therapy besides corticosteroids.

∙ This group includes subjects with PCM1-JAK2, BCR-JAK2, ETV6-JAK2 or other JAK2 rearrangements.

• If receiving corticosteroids, must be a stable dose for \>= 28 days prior to Day 1 (unstable dosing not eligible).

• Eastern Cooperative Oncology Group (ECOG) performance status =\< 3.

• Willing and able to review and execute informed consent (legally-authorized consent acceptable).

Locations
United States
California
Stanford Cancer Institute Palo Alto
RECRUITING
Palo Alto
Oregon
OHSU Knight Cancer Institute
TERMINATED
Portland
Utah
University of Utah
TERMINATED
Salt Lake City
Washington
Fred Hutchinson cancer research center
TERMINATED
Seattle
Contact Information
Primary
Tiffany Nguyen
tnguye10@stanford.edu
650-725-9167
Time Frame
Start Date: 2019-11-15
Estimated Completion Date: 2025-11-30
Participants
Target number of participants: 10
Treatments
Experimental: Treatment (ruxolitinib)
Patients receive ruxolitinib PO BID on days 1-28. Treatment repeats for up to 6 cycles (28 days each) in the absence of disease progression or unacceptable toxicity.
Sponsors
Leads: William Shomali
Collaborators: Incyte Corporation

This content was sourced from clinicaltrials.gov

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