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| Name | Class |
|---|---|
| Cancer Institute and Hospital, Chinese Academy of Medical Sciences | OTHER |
| Peking University Cancer Hospital & Institute | OTHER |
| Second Affiliated Hospital, School of Medicine, Zhejiang University | OTHER |
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This study will assess the Efficacy and Safety of different doses of PEG-rhG-CSF and a single-dose of G-CSF in Preventing Chemotherapy-induced Neutropenia.
The study consist of a screening period and a 21-day chemotherapy period of the same chemotherapy treatment cycle(s).Screening the subjects according to the inclusion criteria and exclusion criteria before 2 weeks of chemotherapy, and the screening successfully patients will be eligible for this study. The 1st chemotherapy treatment cycle defined as subjects screening period, subjects will be treated with the TC or EC regimen on the 1st day, aiming to screen out Chemotherapy-induced Neutropenia of ≥grade 3 (ANC<1.0×10^9/L) who can have the eligible to enter the 2nd chemotherapy treatment cycle, otherwise to quit the study. On the 1st day in cycle 2, subjects will be treated with the same regimen as the 1st chemotherapy treatment cycle, and be received the test drugs or controlled from the 3rd day to observe the efficacy and safety.
【Primary Outcome Measures】:
• Duration of ≥grade 3 neutropenia in cycle 2
【Secondary Outcome Measures】:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pegfilgrastim,30mcg/kg | Experimental | On the 3rd day and 6th day in Cycle 2, mean after 48h and 120h of chemotherapy, subjects will be received PEG-rhG-CSF(sc) in a fixed time(9:00±30 min), and the dosage is 30 mcg/kg. |
|
| pegfilgrastim, 60mcg/kg | Experimental | On the 3rd day in Cycle 2, mean after 48h of chemotherapy, subjects will be assigned to PEG-rhG-CSF(sc, single) in a fixed time(9:00±30 min), and the dosage is 60 mcg/kg. |
|
| pegfilgrastim,100mcg/kg | Experimental | On the 3rd day in Cycle 2, mean after 48h of chemotherapy, subjects will be assigned to PEG-rhG-CSF(sc, single) in a fixed time(9:00±30 min), and the dosage is 100 mcg/kg. |
|
| filgrastim,5mcg/kg | Experimental | On the 3rd day in Cycle 2, mean after 48h of chemotherapy, subjects will be assigned to controlled group with rhG-CSF(sc, once a day) in a fixed time(9:00±30 min), and the dosage is 5mcg/kg, rhG-CSF must be injected for a continous 14 days, or twice observed the results for ANC from the nadir to counts≥5.0×10^9/L, but at least 7 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pegfilgrastim,30mcg/kg | Drug | Two doses SC injection of 30 mcg/kg at postchemotherapy 48hr and 120hr in cycle 2. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Duration of ≥grade 3 neutropenia in cycle 2 | 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| change of Neutropenia and ANC in cycle 2 |
| 21 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yan Qin, M.D. | Contact | 010-8778-8507 |
| Name | Affiliation | Role |
|---|---|---|
| Yuankai Shi | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Institute and Hospital, CAMS | Recruiting | Beijing | China |
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| ID | Term |
|---|---|
| D009503 | Neutropenia |
| ID | Term |
|---|---|
| D000380 | Agranulocytosis |
| D007970 | Leukopenia |
| D000095542 | Cytopenia |
| D006402 | Hematologic Diseases |
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| ID | Term |
|---|---|
| C455861 | pegfilgrastim |
| D000069585 | Filgrastim |
| ID | Term |
|---|---|
| D016179 | Granulocyte Colony-Stimulating Factor |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
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| Jiangsu Cancer Institute & Hospital | OTHER |
| The First Affiliated Hospital with Nanjing Medical University | OTHER |
| Wuhan TongJi Hospital | OTHER |
| The Affiliated Hospital of Inner Mongolia Medical University | OTHER |
| Shandong Cancer Hospital and Institute | OTHER |
| Changsha Central Hospital | OTHER |
| Yangzhou No.1 People's Hospital | OTHER |
| Subei People's Hospital of Jiangsu Province | OTHER |
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| pegfilgrastim, 60mcg/kg | Drug | Single SC injection of the appropriate dose of drug ranging from 60 mcg/kg to 100 mcg/kg at postchemotherapy 48hr in cycle 2. |
|
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| pegfilgrastim, 100mcg/kg | Drug | Single SC injection of the appropriate dose of drug ranging from 60 mcg/kg to 100 mcg/kg at postchemotherapy 48hr in cycle 2. |
|
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| filgrastim, 5mcg/kg | Drug | At least 7 days SC injection of 5 mcg/kg at postchemotherapy 48hr in cycle 2. |
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| D006425 |
| Hemic and Lymphatic Diseases |
| D007960 | Leukocyte Disorders |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |