A Phase 4 interventional study of PEG-rhG-CSF and rhG-CSF in Lymphoma, Non-Hodgkin, Granulocyte Colony-Stimulating Factor and Cost-Benefit Analysis, sponsored by Ruijin Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-09-10.
Sponsored by Ruijin Hospital · Phase 4, Interventional, and Treatment
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.
5,577 studies on the registry are indexed under Lymphoma; 824 are open to participants now.
This study's planned enrollment of 250 is above the median of 40 across 4,507 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →Ruijin Hospital is the lead sponsor of 635 studies on the registry; 360 are open to participants now.
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Exclusion Criteria:
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
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
Patients will be given PEG-rhG-CSF for primary/secondary prevention each cycle.
Patients will be given rhG-CSF for either primary/secondary prevention or treatment once any neutropenia each cycle.
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
Time frame: 1 year
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
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 1 year
Relative dosage intensity
comparison between planned and actual chemotherapy dosage in each cycle
Time frame: 1 year
Usage rate of antibiotics
Usage rate of antibiotics during study period
Time frame: 1 year
Adverse events
incidence and severity of adverse events during study period
Time frame: 1 year
This study is status unknown, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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Ruijin Hospital