Cost-Benefit Analysis, Granulocyte Colony-Stimulating Factor, Lymphoma, Non-Hodgkin
Conditions
Brief summary
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.
Interventions
DRUGPEG-rhG-CSF
Patients will be given PEG-rhG-CSF for primary/secondary prevention each cycle.
DRUGrhG-CSF
Patients will be given rhG-CSF for either primary/secondary prevention or treatment once any neutropenia each cycle.
Sponsors
Ruijin Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incremental Cost-Effectiveness ratio | 1 year | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of febrile neutropenia | 1 year | Incidence of febrile neutropenia （i.e. absolute neutrophil count\<0.5×10\^9/L and temperature ≥38℃）in each cycle |
| Duration time of febrile neutropenia | 1 year | Duration time of febrile neutropenia （i.e. absolute neutrophil count\<0.5×10\^9/L and temperature ≥38℃）in each cycle |
| Cost-Effectiveness ratio | 1 year | 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 |
| Incidence of grade 3-4 neutropenia | 1 year | Incidence of grade 3-4 neutropenia（i.e. absolute neutrophil count\<1×10\^9/L）in each cycle |
| Sensitivity analysis | 1 year | 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. |
| Relative dosage intensity | 1 year | comparison between planned and actual chemotherapy dosage in each cycle |
| Usage rate of antibiotics | 1 year | Usage rate of antibiotics during study period |
| Adverse events | 1 year | incidence and severity of adverse events during study period |
| Duration time of grade 3-4 neutropenia | 1 year | Duration time of grade 3-4 neutropenia（i.e. absolute neutrophil count\<1×10\^9/L）in each cycle |
Countries
China
Contacts
Primary ContactWeili Zhao, PhD
Outcome results
None listed