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| Name | Class |
|---|---|
| Jiangsu HengRui Medicine Co., Ltd. | INDUSTRY |
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The purpose of the study is to evaluate the efficacy and safety of PEG-rhG-CSF compared with rhG-CSF on the recovery of hematopoietic function after autologous stem cell transplantation in patients with lymphoma.
The purpose of the study is to evaluate the efficacy and safety of PEG-rhG-CSF compared with rhG-CSF in lymphoma patients after autologous hematopoietic stem cell transplantation. Eligible patients were randomly assigned to PEG-rhG-CSF group or rhG-CSF group. Patients in PEG-rhG-CSF group received PEG-rhG-CSF day +1 after transplantation with a dose of 6 mg. Patients in rhG-CSF group received rhG-CSF day +1 after transplantation with a dose of 5μg/kg once per day until the count of neutrophil>0.5×10^9 /L.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PEG-rhG-CSF | Experimental | Patients in PEG-rhG-CSF group received PEG-rhG-CSF day+1 after transplantation. |
|
| rhG-CSF | Active Comparator | Patients in rhG-CSF group received rhG-CSF day+1 after transplantation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PEG-rhG-CSF | Drug | PEG-rhG-CSF was given day +1 after autologous stem cell transplantation with a dose of 6mg. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to neutrophil engraftment | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| The duration of neutrophilic granulocytopenia | 30 days | |
| Incidence of febrile neutrophilic granulocytopenia | 30 days | |
| Time to platelet engraftment and number of platelet transfused to the patient |
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Inclusion Criteria:
8.Not in pregnancy; 9.Written informed consent are acquired.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Huiqiang Huang, professor | Contact | 0086-13808885154 | huang_sysu@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Huiqiang Huang, professor | Sun Yat-sen University | Principal Investigator |
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| ID | Term |
|---|---|
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
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| ID | Term |
|---|---|
| C423652 | pegylated granulocyte colony-stimulating factor |
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| rhG-CSF | Drug | rhG-CSF was given day +1 after autologous stem cell transplantation with a dose of 5μg/kg once per day until the count of neutrophil>0.5×10^9 /L. |
|
| 30 days |
| Adverse Event | Safety | 30 days |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |