Actively Recruiting
Ruxolitinib With De-Intensified HLH-94 for the Treatment of Hemophagocytic Lymphohistiocytosis (HLH)
Led by Jerry Lee, MD, MSc, MPhil · Updated on 2026-04-13
36
Participants Needed
3
Research Sites
269 weeks
Total Duration
On this page
Sponsors
J
Jerry Lee, MD, MSc, MPhil
Lead Sponsor
I
Incyte Corporation
Collaborating Sponsor
AI-Summary
What this Trial Is About
This phase II trial tests the effects of ruxolitinib in combination with a de-intensified HLH-94 drug regimen has on patients with newly diagnosed hemophagocytic lymphohistiocytosis (HLH), a disorder caused by dysregulated immune responses (that is, immune responses that are too strong and cause inflammatory damage to normal tissues). The therapy used for HLH decreases the activity of the immune system. Ruxolitinib is a type of drug called a kinase inhibitor. It works by blocking the signals that cause inflammatory cells to multiply. De-intensified HLH-94 is a treatment regimen that includes 4 weeks of dexamethasone with the dose being decreased each week, and up to 4 weeks of etoposide. This combination is commonly used to treat HLH. Dexamethasone is a steroid medication that works by fighting inflammation. Etoposide is in a class of medications known as podophyllotoxin derivatives. It blocks a certain enzyme needed for cell division and deoxyribonucleic acid (DNA) repair and may kill cancer cells and is used to kill the types of white blood cells in HLH that are attacking the body. Giving ruxolitinib in combination with a de-intensified HLH-94 drug regimen may reduce toxic exposure to therapy while maintaining efficacy in patients with HLH.
CONDITIONS
Official Title
Ruxolitinib With De-Intensified HLH-94 for the Treatment of Hemophagocytic Lymphohistiocytosis (HLH)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to understand and willing to sign informed consent.
- Male or female aged 18 years or older at enrollment.
- Active HLH meeting at least 5 of 8 HLH-2004 diagnostic criteria or familial/primary HLH with pathogenic genetic variants.
- Agree to use effective contraception during the study and for two months after last treatment.
- Women of child-bearing potential must have a negative pregnancy test within 7 days before treatment.
You will not qualify if you...
- Received any other investigational agent within 1 week before first treatment dose.
- Pregnant or breastfeeding females.
- Males who plan to conceive or decline effective contraception during the study.
- Unable to take medications orally or via feeding tube.
- Life expectancy less than 2 weeks.
- Significant or uncontrolled heart disease including recent heart attack, stroke, severe heart failure, or arrhythmia.
- Creatinine clearance below 15 mL/min if not on dialysis.
- Known or suspected severe liver cirrhosis or very high liver enzymes not expected to improve.
- Severe organ failure requiring inotropic support or extracorporeal life support.
- Newly diagnosed active tuberculosis, hepatitis B, or hepatitis C.
- Prior malignancy that may interfere with study safety or results.
- HLH related to CAR-T therapy.
- Prior HLH therapy except corticosteroids for less than 2 weeks and anakinra; other specified HLH treatments not allowed.
- Allergy or hypersensitivity to ruxolitinib or its ingredients.
AI-Screening
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Trial Site Locations
Total: 3 locations
1
University of California, Irvine
Irvine, California, United States, 92697
Actively Recruiting
2
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817
Actively Recruiting
3
University of California, San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
Research Team
U
UCSF Hematopoietic Malignancies Clinical Trial Recruitment
CONTACT
C
Claudia Ramos
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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