Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is to examine which dose of YPEG-rhG-CSF, once-per-cycle, has similar efficacy and safety, comparing to PEG-rhG-CSF, once-per-cycle, in chemotherapy-induced neutropenia
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| YPEG-rhG-CSF 20μg/kg | Experimental | 20μg/kg,single s.c. at 48hrs after chemotherapy for each experimental cycle |
|
| YPEG-rhG-CSF 30μg/kg | Experimental | 30μg/kg,single s.c. at 48hrs after chemotherapy for each experimental cycle |
|
| YPEG-rhG-CSF 45μg/kg | Experimental | 45μg/kg,single s.c. at 48hrs after chemotherapy for each experimental cycle |
|
| PEG-rhG-CSF 100μg/kg | Active Comparator | 100μg/kg,single s.c. at 48hrs after chemotherapy for each experimental cycle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YPEG-rhG-CSF, 20μg/kg, single s.c. at 48hrs after chemotherapy for each experimental cycle | Drug |
| ||
| YPEG-rhG-CSF, 30μg/kg, single s.c. at 48hrs after chemotherapy for each experimental cycle |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Grade 3 &4 neutropenia, and median duration of neutropenia in the two experimental cycles | Grade 3 and 4 neutropenia means absolute neutrophil count is less than 1000/mm3 and 500/mm3 , respectively | 21 day |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of febrile neutropenia in the two experimental cycles | Febrile neutropenia means absolute neutrophil count is less than 500/mm3 or absolute neutrophil count between 500/mm3 and 1000mm3 but probably to decline to less than 500mm3 within 48hrs, and body temperature is higher than 38.5 degrees celsius or higher than 38.0 degrees celsius and lasting for more than 1hr | 21 day |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Yuankai Shi, Ph.D | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhangzhou Municipal Hospital of Fujian Province | Zhangzhou | Fujian | 363000 | China | ||
| Shaaxi Provincial Tumor Hospital |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
|
| YPEG-rhG-CSF, 45μg/kg, single s.c. at 48hrs after chemotherapy for each experimental cycle | Drug |
|
| PEG-rhG-CSF, 100μg/kg, single s.c. at 48hrs after chemotherapy for each experimental cycle | Drug |
|
| Diversification of neutrophil in the two experimental cycles | 21 day |
| Xi'an |
| Shaanxi |
| 710061 |
| China |
| Cancer Institute and Hospital, CAMS | Beijing | China |
| Fujian cancer hospital | Fuzhou | China |
| Fujian Medical University Union Hospital | Fuzhou | China |
| Fuzhou General Hospital of Nanjing Military Command | Fuzhou | China |
| The First Affiliated Hospital of Guangzhou Medical University | Guangzhou | China |
| Shanghai Changzheng Hospital | Shanghai | China |
| Shanghai Chest Hospital | Shanghai | China |
| Tongji Hospital, Tongji Medical College Huazhou University of Science & Technology | Wuhan | China |
| The First Affiliated Hospital of Xiamen University | Xiamen | China |
| Zhejiang cancer hospital | Zhejiang | China |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D001943 | Breast Neoplasms |
| D009503 | Neutropenia |
| D064147 | Febrile Neutropenia |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D000380 | Agranulocytosis |
| D007970 | Leukopenia |
| D000095542 | Cytopenia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007960 | Leukocyte Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| C423652 | pegylated granulocyte colony-stimulating factor |
Not provided
Not provided
Not provided