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| Name | Class |
|---|---|
| Beijing Friendship Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PEG-rhG-CSF group | Experimental | 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 |
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| rhG-CSF group | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PEG-rhG-CSF | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Neutrophil dynamic changes |
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Inclusion criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhao Wang, PHD | Contact | 86-1063139862 | catenny@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Zhao Wang, PHD | Beijing Friendship Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Friendship Hospital | Beijing | China |
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| ID | Term |
|---|---|
| D051359 | Lymphohistiocytosis, Hemophagocytic |
| ID | Term |
|---|---|
| D015616 | Histiocytosis, Non-Langerhans-Cell |
| D015614 | Histiocytosis |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C423652 | pegylated granulocyte colony-stimulating factor |
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| rhG-CSF | Drug | 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. |
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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. |
| 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. |