NCT03801434

Ruxolitinib in Treating Patients With Hypereosinophilic Syndrome or Primary Eosinophilic Disorders

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: William Shomali · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• BCR-JAK2 Fusion Protein Expression
• Blasts 20 Percent or Less of Peripheral Blood White Cells
• Blasts More Than 5 Percent of Bone Marrow Nucleated Cells
• Blasts More Than 5 Percent of Peripheral Blood White Cells
• Blasts Under 20 Percent of Bone Marrow Nucleated Cells
• Chronic Eosinophilic Leukemia, Not Otherwise Specified
• Eosinophilia
• Hepatomegaly
• Hypereosinophilic Syndrome
• JAK2 Gene Mutation
• Splenomegaly
• TEL-JAK2 Fusion Protein Expression

Interventions

Type	Name	Description
DRUG	Ruxolitinib	Given PO

Timeline

• Start date: 2019-11-15
• Primary completion: 2028-12-30
• Completion: 2028-12-30
• First posted: 2019-01-11
• Last updated: 2025-12-23

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study