Phase 2
N=6
A Pilot Study of Ruxolitinib in Secondary Hemophagocytic Syndrome
Hemophagocytic Syndrome (HPS)
Bottom Line
View on ClinicalTrials.gov: NCT02400463 ↗Enrolled (actual)
6
Serious AEs
33.3%
Results posted
Nov 2020
Primary outcome: Primary: Overall Survival at 2 Months — 6 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Ruxolitinib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Michigan Rogel Cancer Center
- Primary completion
- Oct 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival at 2 Months |
6 | — |
| SECONDARY Percentage of Patients With a Response to Treatment With Ruxolitinib |
100 | — |
| SECONDARY Duration of Response |
17.25 | — |
| SECONDARY Progression Free Survival Time |
17.25 | — |
| SECONDARY Regimen Related Toxicities |
5; 3; 1; 1 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- 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 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.
Exclusion Criteria
- 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 20.
Data sourced from ClinicalTrials.gov (NCT02400463). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.