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| Name | Class |
|---|---|
| Cancer Institute and Hospital, Chinese Academy of Medical Sciences | OTHER |
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This phase 3 study is aimed to evaluate the safety and efficacy of YPEG-rhG-CSF in reducing the infection manifested by febrile neutropenia in patients with non-myeloid malignancy who receiving Myelosuppressive Chemotherapy which is likely to cause clinically significant febrile neutropenia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| YPEG-rhG-CSF 2mg | Experimental | YPEG-rhG-CSF 2mg |
|
| YPEG-rhG-CSF 33μg/kg | Experimental | YPEG-rhG-CSF 33μg/kg |
|
| Positive Control Group | Active Comparator | rhG-CSF/PEG-rhG-CSF |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YPEG-rhG-CSF | Drug | YPEG-rhG-CSF 2mg, single s.c. at day 3 of each cycles, up to 4 cycles. 21 day one cycles. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Duration of Severe Neutropenia (DSN) During Cycle 1. | Mean duration of severe neutropenia, defined as number of consecutive days with absolute neutrophil count (ANC) <0.5 × 10^9 cells/l (grade 4 neutropenia) | At the end of Cycle 1 (21 days one cycle) |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Febrile neutropenia(FN). | FN defines as the ANC counts is less than < 0.5 × 10^9 cells/L or ANC counts between 0.5 × 10^9 cells/L and 1.0 × 10^9 cells/L but probably to decline to less than 0.5×10^9 cells/L within 48hrs, and body temperature is higher than 38.3 degrees Celsius or higher than 38.0 degrees Celsius and lasting for more than 1hr. | Cycle1 to Cycle 4(21 days one cycle) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital Chinese Academy of Medical Sciences | Beijing | Beijing Municipality | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40098083 | Derived | Shi Y, Wang X, Pei Z, Shi H, Zhang Y, Yi T, Mei J, Guo Y, Dong Y, Ma T, Zhang Q, Jia X, Zhu Z, Xu S, Liu Y, Niu H, Jiang W, Jiang X, Zhou S, Sun L. Telpegfilgrastim for chemotherapy-induced neutropenia in patients with non-small cell lung cancer: a multicentre, randomized, phase 3 study. BMC Cancer. 2025 Mar 17;25(1):490. doi: 10.1186/s12885-025-13736-6. |
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| ID | Term |
|---|---|
| D064147 | Febrile Neutropenia |
| D009503 | Neutropenia |
| ID | Term |
|---|---|
| D000380 | Agranulocytosis |
| D007970 | Leukopenia |
| D000095542 | Cytopenia |
| D006402 | Hematologic Diseases |
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| ID | Term |
|---|---|
| C423652 | pegylated granulocyte colony-stimulating factor |
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| YPEG-rhG-CSF | Drug | YPEG-rhG-CSF 33μg/kg, single s.c. at day 3 of each cycles, up to 4 cycles. 21 day one cycles. |
|
| rhG-CSF/PEG-rhG-CSF | Drug | rhG-CSF 5μg/kg/day, s.c. from day 3 to day 14 or until neutrophils recover to exceed 5.0×10^9 cells/L, whichever comes first, in the first cycle. Patient can still continue rhG-CSF 5μg/kg/day, or covert to PEG-rhG-CSF 6mg/Cycle in the following 2-4 cycle. 21 day one cycles. |
|
| Mean duration of DSN. | Cycle2 to Cycle 4 (21 days one cycle) |
| Incidence of Grade 3 neutropenia. | Grade 3 neutropenia defines as the ANC count is less than 1.0×10^9 cells/L. | Cycle1 to Cycle 4 ( 21 days one cycle) |
| Mean duration of grade 3 neutropenia. | Cycle1 to Cycle 4(21 days one cycle) |
| Neutrophils dynamic changes from baseline. | Cycle1 to Cycle 4 ( 21 days one cycle) |
| Time of neutrophils recovering to over 2.0×10^9 cells/L after nadir. | Cycle1 to Cycle 4 (21 days one cycle) |
| Proportion of patients with antibiotic usage. | Cycle1 to Cycle 4 ( 21 days one cycle) |
| Proportion of patients experienced infection. | Cycle1 to Cycle 4 ( 21 days one cycle) |
| Proportion of patients fulfilling expected chemotherapy. | Cycle1 to Cycle 4 (21 days one cycle) |
| D006425 |
| Hemic and Lymphatic Diseases |
| D007960 | Leukocyte Disorders |