Hemophagocytic Syndrome Clinical Trial
Official title:
A Single-center, Open-label, Controlled Clinical Study to Evaluate the Efficacy and Safety of Jinyouli®(PEG-rhG-CSF) for the Recovery of Neutropenia After Chemotherapy in Patients With Hemophagocytic Syndrome
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.
Status | Not yet recruiting |
Enrollment | 50 |
Est. completion date | September 1, 2022 |
Est. primary completion date | August 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
China | Beijing Friendship Hospital | Beijing |
Lead Sponsor | Collaborator |
---|---|
CSPC Baike (Shandong) Biopharmaceutical Co., Ltd. | Beijing Friendship Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Duration of grade IV neutropenia | Defined as days when the ANC<0.5×10^9/L occurs to the time when the ANC=0.5×10^9/L. | From date of randomization until the date of the study completion,up to 1 year. | |
Secondary | The recovery time of neutrophils after chemotherapy | Defined as days when the ANC<2.0×10^9/L occurs to the time when the ANC=2.0×10^9/L. | From date of randomization until the date of the study completion,up to 1 year. | |
Secondary | Neutrophil dynamic changes | The dynamic changes of neutrophil count were observed after chemotherapy. | From date of randomization until the date of the study completion,up to 1 year. | |
Secondary | Efficacy evaluation of salvage therapy | Complete response (CR) and partial response (PR) rates. | From date of randomization until the date of the study completion,up to 1 year. |
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