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| Name | Class |
|---|---|
| Hebei Medical University Fourth Hospital | OTHER |
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The main treatments for non-Hodgkin's lymphoma are surgery, radiotherapy, chemotherapy, and bone marrow transplantation. Neutropenia is the most common and serious complication of most chemotherapy. This study is a multi-center, open-label, single-arm clinical study to evaluate the efficacy and safety of jinyouli in preventing neutropenia in patients with non Hodgkin's lymphoma after chemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PEG-rhG-CSF group | Experimental | Patients received subcutaneous injection of PEG-rhG-CSF(Jinyouli®) 48 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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PEG-rhG-CSF | Drug | Patients received a single dose of PEG-rhG-CSF per cycle. The chemotherapy regimen must meet the interval between two chemotherapy sessions at least 12 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of grade Ⅲ/Ⅳ neutropenia | Grade Ⅲ neutropenia is defined as ANC≥0.5×10^9/L, and <1×10^9/L; Grade Ⅳ neutropenia is defined as ANC<0.5×10^9/L | From date of randomization until the date of the study completion，up to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of febrile neutropenia (FN) | A single oral temperature is 38.3℃ or ≥38℃ for more than 1 h, and the absolute value of neutrophils is less than 0.5×10^9/L or the absolute value of neutrophils is less than 1.0×10^9/L but it is expected to drop to less than 0.5×10^9/L within 48 hours | From date of randomization until the date of the study completion，up to 24 weeks |
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Inclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lihong Liu, PHD | Contact | 86-13831177920 | 13831177920@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Lihong Liu, PHD | Hebei Medical University Fourth Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The fourth hospital of Hebei Medical University | Recruiting | Shijiazhuang | Hebei | 050019 | China |
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| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
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| ID | Term |
|---|---|
| C423652 | pegylated granulocyte colony-stimulating factor |
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| Antibiotic use rate | Antibiotic use rate during the treatment cycle | From date of randomization until the date of the study completion，up to 24 weeks |
| Incidence of dose adjustment of chemotherapy or delay of chemotherapy | Dose adjustment is defined as the reduction of planned dose of chemotherapy; Chemotherapy delay is defined as the delay in starting the next planned chemotherapy for more than 3 days. | From date of randomization until the date of the study completion，up to 24 weeks |
| D008206 |
| Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |