Cytokine-guided treatment for pediatric hemophagocytic lymphohistiocytosis
Clinical Study on the Treatment of Pediatric Hemophagocytic Lymphohistiocytosis Based on Cytokine Guided Risk Stratification：A Multicenter Randomized Controlled Study
This study is testing a new way to treat children with a serious immune disorder called hemophagocytic lymphohistiocytosis by grouping them based on their cytokine levels to see which treatments work best for each risk level.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 1 Day to 18 Years |
| Sex | All |
| Sponsor | The Children's Hospital of Zhejiang University School of Medicine Academic / other |
| Drugs / interventions | ruxolitinib |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT05491304 on ClinicalTrials.gov |
What this trial studies
This study focuses on pediatric patients diagnosed with hemophagocytic lymphohistiocytosis (HLH), a severe immune disorder. It aims to stratify patients into low, intermediate, and high-risk groups based on their cytokine levels, specifically IL-10 and IFN-γ. The treatment approach will vary according to the risk group, with options including steroids, ruxolitinib, or a combination of dexamethasone and etoposide for high-risk patients. The study is multicenter and prospective, involving several hospitals across Asia to gather comprehensive data on treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates are children aged 1 day to 18 years who are newly diagnosed with HLH and meet the HLH criteria.
Not a fit: Patients who have received steroids or etoposide within 72 hours prior to diagnosis will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve survival rates in children with HLH by providing tailored treatment strategies.
How similar studies have performed: Previous studies have shown promising results in risk stratification based on cytokine levels, but this multicenter prospective approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age from one day to 18 years old； * Newly diagnosed HLH, fulfilling the HLH criteria; * To observed the early diagnosis role of cytokines, patients who is suspected to be HLH and fulfill 3 out of 8 criteria can be pre-enrolled. Exclusion Criteria: * treated with steroids or etoposide within 72 hours before diagnosis.
Where this trial is running
Hangzhou, Zhejiang
- The Children's Hospital of Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Principal investigator: Xiaojun Xu, MD — The Children's Hospital of Zhejiang University School of Medicine
- Study coordinator: Xiaojun Xu, MD
- Email: xuxiaojun@zju.edu.cn
- Phone: +8657188873617
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.