This phase II trial studies how well ruxolitinib works in treating patients with hypereosinophilic syndrome or primary eosinophilic disorders.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Given PO
Stanford Cancer Institute Palo Alto
Palo Alto, California, United States
RECRUITINGOHSU Knight Cancer Institute
Portland, Oregon, United States
TERMINATEDUniversity of Utah
Salt Lake City, Utah, United States
TERMINATEDFred Hutchinson cancer research center
Seattle, Washington, United States
TERMINATEDOverall response rate (ORR)
ORR is the sum of complete response (CR) plus complete response with incomplete platelet recovery (CRp) plus partial response (PR). Complete response, with platelet incomplete platelet recovery (CRp) is defined as a response that meets CR criteria but platelet count remains below 100 x 10\^9/L. This outcome will be reported as a number. * Complete response (CR) = normalization of white blood cell (WBC) count; absolute eosinophil count in blood; and % eosinophils in blood, without increased blasts or eosinophils in bone marrow, and with a non-palpable spleen and/ or normal spleen size by imaging. * Partial response (PR) is defined as ≥ 50% reduction (if above normal range) in all the following: total WBC count; absolute eosinophil count in blood; % eosinophils in blood; % eosinophils and myeloblasts in bone marrow; in addition to spleen size reduction of ≥ 50% by palpation and/ or ≥35% by imaging (if increased at baseline).
Time frame: 3 years
Adverse events
Adverse events will be reported including severity, seriousness, and relatedness of adverse events based on National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. The outcome will be reported as a number of all serious adverse events; with frequency ≥ 10%.
Time frame: 3 years
Proportion of subjects who become corticosteroid-independent
Descriptive analysis of the proportion of subjects who become corticosteroid-independent for 12 or more consecutive weeks will be reported. The outcomes will be reported as number
Time frame: 3 years
Proportion of patients who reduce corticosteroid dose by >= 50% (including patients who become corticosteroid-independent)
Descriptive analysis of the proportion of subjects who reduce corticosteroid dose by \>= 50% (including patients who become corticosteroid-independent) for 12 or more consecutive weeks will be reported. The outcomes will be reported as number
Time frame: 3 years
Duration of response (DoR)
Median duration of response (DoR) defined as the time from first onset of confirmed response to the date of first documented and confirmed progression or death due to hypereosinophilic syndrome or a primary eosinophilic neoplasm. This outcome will be reported as the median with full range, for those subjects that achieve a clinical response. Response defined as per the Primary Outcome.
Time frame: 3 years
Time to response (TTR)
Median time to response (TTR) is defined as the time from start of treatment until the date of onset of a confirmed response. This outcome will be reported as the median with full range, for those subjects that achieve a clinical response.
Time frame: 3 years
Median Progression-free survival (PFS)
Median progression free survival (PFS) is defined as the time from start of treatment to the date of the first documented and confirmed progression or death or institution of new therapy. This outcome will be reported as the median with full range. Progression is defined as ≥ 25% in one of the following when compared to baseline: total WBC count; absolute eosinophil count in blood; or % eosinophils in blood; OR the presence of ≥ 20% blasts in the peripheral blood or bone marrow ("evolution to AML"), with any lab finding confirmed at 2 weeks; or ≥ 25% increase in spleen size.
Time frame: 3 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.