A Pilot Study of Ruxolitinib in Secondary Hemophagocytic Syndrome

Completed · Phase 2

Conditions studied: Hemophagocytic Syndrome (HPS)

In brief

This is a pilot study to determine the efficacy of Ruxolitinib in secondary hemophagocytic syndrome. The primary objective is to assess the efficacy of ruxolitinib 15 mg PO twice daily in patients with HPS. The primary endpoint is overall survival at two months.

Key facts

Study ID

NCT02400463

Run by

University of Michigan Rogel Cancer Center

People needed

6

Starts

2016-02-05

Expected to finish

2020-01-07

Last updated by the study team

2021-01-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients, or their legally authorized representative, must voluntarily provide written IRB-approved informed consent.
• Males and females, 18 years of age or older at the time of enrollment.
• Patients must meet the diagnostic criteria for HPS (at least 5 of the following): fever, splenomegaly, cytopenia involving ≥2 cell lines (Hemoglobin <9 g/dL; platelets <100,000/μL; absolute neutrophil count <1000/μL), hypertriglyceridemia or hypofibrinogenemia, tissue demonstration of hemophagocytosis, low or absent NK (Natural Killer) cell activity, serum ferritin ≥3000 ug/L, soluble IL-2 receptor (CD25) >2400 U/mL.
• In the investigator's opinion, the patient has the ability to participate fully in the study, and comply with all its requirements.

You may not qualify if…

• CNS (Central Nervous System) involvement
• Malabsorption
• Known secondary HPS (Hemophagocytic Syndrome) that is otherwise treatable (e.g. non-Hodgkin's lymphoma).
• Pregnant or lactating female: all females of child-bearing potential must have a negative serum pregnancy test within 7 days of treatment; lactating females must discontinue breast feeding.
• Estimated creatinine clearance <15mL/min
• Has received any prior systemic therapy, excluding corticosteroids, within 7 days (or 5 half-lives) of treatment.
• No active malignancy at the time of enrollment, except nonmelanoma skin cancers or carcinoma in situ. Patients with a prior history of malignancy are eligible if their malignancy has been definitely treated or is in remission and does not require ongoing adjuvant or cancer-directed therapies.
• Active hepatitis B or hepatitis C or known HIV infection
• Known (and biopsy-confirmed) liver cirrhosis; or, a reported history of liver cirrhosis with a Model for End-stage Liver Disease (MELD) score >20.

Where it is running

• University of Michigan Comprehensive Cancer Center — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

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