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
A multicenter, open, one-arm clinical study evaluated the efficacy and safety of Jinyouli in preventing neutropenia after chemotherapy in elderly lymphoma patients who met the criteria for admission. Chemotherapy regimen: The investigator selected according to the specific condition the corresponding standard chemotherapy regimen, the chemotherapy regimen used, FN risk ≥ 20%, or 10% < FN risk < 20% with at least one high risk factor for FN, from the first cycle of chemotherapy, 24-72 after chemotherapy hour subcutaneous injection of Jinyouli.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PEG-rhG-CSF | Experimental | Jin Youli(PEG-rhG-CSF):From the first cycle of chemotherapy, Jin Youli(PEG-rhG-CSF) was injected subcutaneously 24-72 hours after the end of chemotherapy, 6 mg was given to patients with body weight ≥45 kg, and 3 mg was given for body weight <45 kg. Inject once every chemotherapy cycle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PEG-rhG-CSF | Drug | The test drug PEG-rhG-CSF was administered prophylactically to elderly lymphoma patients who met the inclusion/exclusion criteria 24-72 hours after chemotherapy. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of febrile neutropenia in cycles 1 to 6 | The body temperature standard for neutropenic fever is sputum temperature; febrile neutropenia is defined as ANC < 0.5*109 / L and sputum temperature> 38.0 ° C. | through 1-6 cycles of PEG-rhG-CSF,an average of 6 month |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of grade IV neutropenia in the first to sixth cycles of PEG-rhG-CSF. | The incidence of grade IV neutropenia in the first to sixth cycles of PEG-rhG-CSF. | through 1-6 cycles of PEG-rhG-CSF,an average of 6 month |
| Incidence of dose adjustment of chemotherapy drugs in each chemotherapy cycle |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Huiqiang Huang | Contact | 13808885154 | huanghq@sysucc.org.cn |
| Name | Affiliation | Role |
|---|---|---|
| Huiqiang Huang | Sun Yat-sen University Cancer Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Hospital | Recruiting | Guangzhou | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Incidence of dose adjustment of chemotherapy drugs in each chemotherapy cycle |
| through 1-6 cycles of PEG-rhG-CSF,an average of 6 month |
| Incidence of chemotherapy delays in each chemotherapy cycle | Incidence of chemotherapy delays in each chemotherapy cycle | through 1-6 cycles of PEG-rhG-CSF,an average of 6 month |
| The proportion of patients receiving antibiotics during the entire chemotherapy period. | The proportion of patients receiving antibiotics during the entire chemotherapy period. | through 1-6 cycles of PEG-rhG-CSF,an average of 6 month |
| ID | Term |
|---|---|
| C423652 | pegylated granulocyte colony-stimulating factor |
Not provided
Not provided
Not provided