Cytokine Guided Risk Stratification and Treatment in Pediatric Hemophagocytic Lymphohistiocytosis
Status:
Not yet recruiting
Trial end date:
2025-12-31
Target enrollment:
Participant gender:
Summary
Hemophagocytic lymphohistiocytosis (HLH) is a rapidly fatal disease caused by
immune-dysregulation characterized by hypercytokinemia, with about 30%-40% of patients
suffering death in children. Stratification strategy and individualized treatment is
important to improve the survival. In our recent retrospective study, risk stratification
based on IL-10 and IFN-γ levels well distinguished patients with different outcomes. In this
multicenter prospective study, we will enroll the newly diagnosed pediatric HLH patients and
divide them into low, intermediate and high-risk cytokine groups according to IFN-γ and IL-10
levels. The patients'clinical manifestation and laboratory findings will be further evaluated
into severe and non-severe groups. For low/intermediate risk and non-severe patients, steroid
or ruxolitinib will be used initially; while those with high risk or severe diseases,
DXM+VP16±ruxolitinib will be administered. The treatment strategy could be adjusted after
evaluation 48-72 hours later.
Phase:
Phase 4
Details
Lead Sponsor:
The Children's Hospital of Zhejiang University School of Medicine
Collaborators:
Children's Hospital of Fudan University Children's Hospital of Nanjing Medical University Children's Hospital Of Soochow University First Affiliated Hospital, Sun Yat-Sen University Hunan Provincial People's Hospital Institute of Hematology & Blood Diseases Hospital Qilu Hospital of Shandong University Second Affiliated Hospital of Wenzhou Medical University Shanghai Children's Hospital Shanghai Children's Medical Center Shenzhen Children's Hospital The Affiliated Hospital of Qingdao University The Second Hospital of Anhui Medical University The Third Xiangya Hospital of Central South University Tongji Hospital Union hospital of Fujian Medical University West China Second University Hospital Wuhan Children's Hospital Xinhua Hospital, Shanghai Jiao Tong University School of Medicine Zunyi Medical College