Evaluate the Efficacy and Safety of PEG-rhG-CSF in Patients With Hemophagocytic Syndrome
- Registration Number
- NCT04500886
- Lead Sponsor
- CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
- Brief Summary
Hemophagocytic syndrome (HPS), also known as hemophagocytic lymphohistiocytosis (HLH), is an immune mediated life-threatening disease. There is no uniform recommendation for salvage treatment of HLH. Based on the results of current clinical trials, the marketing situation of the drug in China, and the use requirements of pegylated recombinant human granulocyte stimulating factor(PEG-rhG-CSF), this study was conducted in patients who received the DEP rescue therapy or dexamethasone combined with VP-16 maintenance therapy. The aim of this study was to evaluate the efficacy and safety of PEG-rhG-CSF(Jinyouli®) for the recovery of neutropenia after chemotherapy in patients with hemophagocytic syndrome.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 50
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PEG-rhG-CSF group PEG-rhG-CSF Patients received subcutaneous injection of PEG-rhG-CSF(Jinyouli®)24 hours after the end of chemotherapy, 6mg for patients with body weight ≥ 45kg and 3mg for patients with body weight less than 45kg, once per chemotherapy cycle rhG-CSF group rhG-CSF Patients received subcutaneous injection of rhG-CSF 24 hours after the end of chemotherapy, 300ug for patients with body weight ≥45kg and 150ug for patients with body weight less than 45kg, Once a day for 3-5 days until the absolute count of neutrophils ≥2×109/L.
- Primary Outcome Measures
Name Time Method Duration of grade IV neutropenia From date of randomization until the date of the study completion，up to 1 year. Defined as days when the ANC\<0.5×10\^9/L occurs to the time when the ANC≥0.5×10\^9/L.
- Secondary Outcome Measures
Name Time Method The recovery time of neutrophils after chemotherapy From date of randomization until the date of the study completion，up to 1 year. Defined as days when the ANC\<2.0×10\^9/L occurs to the time when the ANC≥2.0×10\^9/L.
Neutrophil dynamic changes From date of randomization until the date of the study completion，up to 1 year. The dynamic changes of neutrophil count were observed after chemotherapy.
Efficacy evaluation of salvage therapy From date of randomization until the date of the study completion，up to 1 year. Complete response (CR) and partial response (PR) rates.
Trial Locations
- Locations (1)
Beijing Friendship Hospital
🇨🇳Beijing, China