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Neutropenia is one of the most frequent adverse effects of chemotherapy, and the main factor to limit the dosage and the continuation of chemotherapy.A newly pegylated rhG-CSF was independently developed by JIANGSU HENGRUI Medicine Co., Ltd, China. Phase 1a, 1b and phase 2 trials have shown that pegylated rhG-CSF has decreased renal clearance, increased plasma half-life, and prolonged efficacy in compare with filgrastim.
This study is to evaluate efficacy and safety in chemotherapy-induced neutropenia of once-per-cycle Mecapegfilgrastim Injection(PEG-G-CSF) and daily G-CSF in Patients with lymphoma patients.
This is a randomized, controlled study. A total of 170 lymphoma patients who are eligible are planned to randomized assigned into two groups to receive mecapegfilgrastim fixed dose of 6 mg or filgrastim 5 µg/kg/day during chemotherapy.
The primary endpoint is the duration of grade ≥3 neutropenia in cycle 1. The secondary endpoints include incidence of grade ≥3 neutropenia and febrile neutropenia (FN) in cycle 1-4, The pharmacoeconomics and safety profile are also evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mecapegfilgrastim | Experimental | Patients were administered pegylated rhG-CSF 6mg once at the 3rd day of every chemotherapy cycle. |
|
| rhG-CSF | Active Comparator | Patients were administered pegylated rhG-CSF 6 ug/kg/day from the 3rd day of every chemotherapy cycle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pegylated rhG-CSF | Drug | Pegylated rhG-CSF:6mg |
| |
| rhG-CSF |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of grade ≥3 neutropenia in cycle 1 | Duration of subjects developing ANC lower than 1.0 × 109/L | 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of grade ≥3 neutropenia in cycle 1-4 | Proportion of subjects developing ANC lower than 1.0 × 109/L from cycle 1 to cycle 4 | 84 days |
| Incidenc of febrile neutropenia (FN) in cycle 1-4 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Bethune Hospital of Jilin University | Recruiting | Changchun | Jilin | 130021 | China |
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| ID | Term |
|---|---|
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
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| ID | Term |
|---|---|
| C423652 | pegylated granulocyte colony-stimulating factor |
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| Drug |
rhG-CSF:5ug/kg/d |
|
Febrile neutropenia means the ANC count is less than 1,000/mm3 and body temperature is more than 38.5 degrees celsius from cycle 1 to cycle 4
| 84 days |
| Incidence of adverse events (AEs) | Analysis of adverse events (AEs) are based on treatment-related AEs (trAEs) according to the Common Terminology Criteria for Adverse Events, version 5.0 | 84 days |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |