Hemophagocytic Syndrome
Conditions
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.
Interventions
DRUGPEG-rhG-CSF
PEG-rhG-CSF is a sustained-duration form of rhG-CSF, a recombinant methionyl form of human granulocyte colony-stimulating factor (G-CSF), similar to rhG-CSF, PEG-rhG-CSF increases the proliferation and differentiation of neutrophils from committed progenitor cells, induces maturation, and enhances the survival and function of mature neutrophils, resulting in dose-dependent increases in neutrophils.
DRUGrhG-CSF
rhG-CSF can increase the proliferation and differentiation of neutrophils from committed progenitor cells, induces maturation, and enhances the survival and function of mature neutrophils.
Sponsors
Beijing Friendship Hospital
CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Contacts
Primary ContactZhao Wang, PHD
Outcome results
None listed