Cost-Effectiveness Study of PEG-rhG-CSF in Prophylactic Treatment of Neutropenia After Chemotherapy in Lymphoma

Study Overview
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Brief Summary
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This is a pharmacoeconomic research to explore the cost-effectiveness of PEG-rhG-CSF and rhG-CSF in prophylactic treatment of neutropenia in lymphoma patients. It should provide more scientific basis for clinical decision-making.

Official Title
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Cost-Effectiveness Study of Pegylated Recombinant Human Granulocyte Colony-stimulating Factor(PEG-rhG-CSF) in Prophylactic Treatment of Neutropenia After Chemotherapy in Lymphoma

Conditions
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Lymphoma, Non-Hodgkin, Granulocyte Colony-Stimulating Factor, Cost-Benefit Analysis

Intervention / Treatment
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* Drug: PEG-rhG-CSF
* Drug: rhG-CSF


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-65 years histologically confirmed de novo Non Hodgkin's lymphoma (except highly aggressive lymphoma such as lymphoblastic lymphoma and Burkitt lymphoma) plan to be given 6-8 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) ± Rituximab (R) KPS ≥70 plan continuous PEG-rhG-CSF or rhG-CSF adiministration after at least 3 cycles of treatment for neutropenia prophylactic treatment absolute neutrophil count≥1.5×109/L，platelet count ≥100× 109/L，hemoglobin≥90g/L，while blood cell count≥3.0×109/L，without bleeding signs adquate liver and renal function as protocol discribed no serious cardiovascular disease as protocol discribed under good mental conditions and informed consented potential benefit for subjects based on investigators' decision Exclusion Criteria: history of hematopoetic stem cell transplantationor organ transplantation uncontrollable infection allergic to study drugs or ingredients accepted any other investigational drug or participated another interventional study within 30 days during screening period other uncontrollable conditions judged by the investigator breast-feeding , pregnant or plan to be pregnant during study observation period

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PEG-rhG-CSF cohort<br>PEG-rhG-CSF primary/secondary prevention will be given 24-72 hours after each cycle for only once. Dosage: 6mg for weight ≥45kg，3mg for weight <45kg, subcutaneous injection | Drug: PEG-rhG-CSF<br>* Patients will be given PEG-rhG-CSF for primary/secondary prevention each cycle.<br>|
| Experimental: rhG-CSF cohort<br>rhG-CSF primary/secondary prevention will be given 24-72 hours after each cycle until absolute neutrophil count ≥2×10^9/L. rhG-CSF treatment will be given when there is neutropenia until absolute neutrophil count ≥2×10^9/L. Dosage: 5μg/kg/d, subcutaneous injection | Drug: rhG-CSF<br>* Patients will be given rhG-CSF for either primary/secondary prevention or treatment once any neutropenia each cycle.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incremental Cost-Effectiveness ratio | A comparison of the different strategies based on the incremental cost-effectiveness ratio (ICER), which is defined by the difference in costs between interventions, divided by the difference in their measured impact | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost-Effectiveness ratio | A comparison of the different strategies based on the cost-effectiveness ratio (ICER), which is defined by the difference in costs between interventions, divided by the difference in their measured impact | 1 year | 
| Sensitivity analysis | A sensitivity analysis is a way of examining Sensitivity to Change in results due to changes in the parameter values applied within a certain scope. | 1 year | 
| Incidence of febrile neutropenia | Incidence of febrile neutropenia （i.e. absolute neutrophil count<0.5×10^9/L and temperature ≥38℃）in each cycle | 1 year | 
| Duration time of febrile neutropenia | Duration time of febrile neutropenia （i.e. absolute neutrophil count<0.5×10^9/L and temperature ≥38℃）in each cycle | 1 year | 
| Incidence of grade 3-4 neutropenia | Incidence of grade 3-4 neutropenia（i.e. absolute neutrophil count<1×10^9/L）in each cycle | 1 year | 
| Duration time of grade 3-4 neutropenia | Duration time of grade 3-4 neutropenia（i.e. absolute neutrophil count<1×10^9/L）in each cycle | 1 year | 
| Relative dosage intensity | comparison between planned and actual chemotherapy dosage in each cycle | 1 year | 
| Usage rate of antibiotics | Usage rate of antibiotics during study period | 1 year | 
| Adverse events | incidence and severity of adverse events during study period | 1 year |