Ruxolitinib Combined With Dexamethasone for HLH
- Conditions
- Hemophagocytic Lymphohistiocytosis
- Interventions
- Registration Number
- NCT03795909
- Lead Sponsor
- Capital Research Institute of Pediatrics
- Brief Summary
A protocol named as "HLH-DR" for patients with refractory and secondary hemophagocytic lymphohistiocytosismay.
- Detailed Description
A modified protocol about ruxolitinib combined with dexamethasone which includes oral ruxolitinib (2.5 mg twice daily for patients if the age\<14 years and the weight \<25kg，5 mg twice daily for patients if the age\<14 years and the weight≥25kg, 10mg twice daily for patients if the age ≥14 years and\<18 years）. Dexamethasone (10mg/m2.d) delayes for the first 2 weeks （form week 1 to 2），(5mg/m2.d) from week 3 to 4，(2.5mg/m2.d) from week 5 to 6），1.25mg/m2.d for week 7，and dropped off on week 8. Every 2 weeks, patients can be evaluated based the diagnosed index
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 50
- Secondary and refractory HLH.
- Family HLH.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Ruxolitinib and Placebo Ruxolitinib Ruxolitinib 2.5 mg twice daily by oral Placebo and Ruxolitinib Dexamethasone Sugar pill 2.5 mg twice daily by oral Ruxolitinib and Placebo Dexamethasone Ruxolitinib 2.5 mg twice daily by oral Placebo and Ruxolitinib Ruxolitinib Sugar pill 2.5 mg twice daily by oral
- Primary Outcome Measures
Name Time Method Severity of disease 2 weeks Serum ferritin\>2000ng/ml, disease actvie; serum ferritin\<2000ng/ml, disease control;
- Secondary Outcome Measures
Name Time Method Axillary temperature 2 weeks 36\<Axillary temperature\<37.2, disease control; 37.2\<Axillary temperature\<38.2, disease partly control; Axillary temperature\>38.2, disease active
Trial Locations
- Locations (1)
Yan Yue
🇨🇳Beijing, China