Lymphoma, Non-Hodgkin Clinical Trial
Official title:
Cost-Effectiveness Study of Pegylated Recombinant Human Granulocyte Colony-stimulating Factor(PEG-rhG-CSF) in Prophylactic Treatment of Neutropenia After Chemotherapy in Lymphoma
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.
Status | Recruiting |
Enrollment | 250 |
Est. completion date | April 1, 2022 |
Est. primary completion date | August 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
China | Ruijin hospital | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Ruijin Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Relative dosage intensity | comparison between planned and actual chemotherapy dosage in each cycle | 1 year | |
Secondary | Usage rate of antibiotics | Usage rate of antibiotics during study period | 1 year | |
Secondary | Adverse events | incidence and severity of adverse events during study period | 1 year |
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