Evaluate the Efficacy and Safety of PEG-rhG-CSF in Patients With Hemophagocytic Syndrome

• Status: Not yet recruiting
• Trial end date: 2022-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
• Collaborator: Beijing Friendship Hospital

Criteria

Inclusion criteria：

1. Age ≥ 18 years old, ≤ 70 years old;

2. Patients with hemophagocytic syndrome diagnosed by HLH-2004 diagnostic criteria;

3. Patients who plan to receive rescue treatment or maintenance treatment;

4. The expected survival time is more than 1 month;

5. Patients sign informed consent form.

Exclusion Criteria：

1. Patients who have received bone marrow or hematopoietic stem cell transplantation in the past 3 months;

2. Patients with brain metastases;

3. Patients who are allergic to this product or other biological products derived from genetic engineering E. coli;

4. People with mental or nervous system disorders who cannot cooperate;

5. Pregnant or lactating female patients; women who refuse to accept contraceptive measures ;

6. Researchers determine unsuited to participate in this trial.