Loading clinical trials...

Ruxolitinib in Treating Patients With Hypereosinophilic Syndrome or Primary Eosinophilic Disorders | Clinical Trials | Clareo Health

RECRUITINGPHASE2

Ruxolitinib in Treating Patients With Hypereosinophilic Syndrome or Primary Eosinophilic Disorders

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

NCT03801434•William Shomali

View on ClinicalTrials.gov

Summary

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

Detailed 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 survival (PFS) and overall survival.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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 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
+8 more criteria

Exclusion Criteria

•Eastern Cooperative Oncology Group (ECOG) performance status =\< 3.
•Willing and able to review and execute informed consent (legally-authorized consent acceptable).
•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.
•Invasive malignancy over the previous 2 years except treated early stage carcinomas of the skin, completely resected intraepithelial carcinoma of the cervix, and completely resected papillary thyroid and follicular thyroid cancers.
•Myeloid or lymphoid neoplasm with eosinophilia and abnormalities of PDGFRA, PDGFRB or FGFR1.
•Anticipated to receive a hematopoietic stem cell transplant within the first 6 months of treatment on trial.
•Major surgery within 4 weeks prior to entering the study.
+14 more criteria

Locations (4)

Stanford Cancer Institute Palo Alto

Palo Alto, California, United States

OHSU Knight Cancer Institute

Portland, Oregon, United States

University of Utah

Salt Lake City, Utah, United States

Fred Hutchinson cancer research center

Seattle, Washington, United States

Key Dates

Start Date

November 15, 2019

Primary Completion Date

December 30, 2028

Completion Date

December 30, 2028

Last Updated

December 23, 2025

Enrollment

ESTIMATED participants

Conditions

BCR-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

Interventions

Ruxolitinib

DRUG

Contacts

Tiffany Nguyen

CONTACT

650-725-9167 tnguye10@stanford.edu