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

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04083079
• Other study ID #: PEG-rhG-CSF-01
• Status: Recruiting
• Phase: Phase 4
• Start date: August 1, 2019
• Est. completion date: April 1, 2022

Study information

• Verified date: September 2019
• Source: Ruijin Hospital
• Contact: Weili Zhao, PhD
• Phone: +86 021 6437045
• Email: zhao.weili[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

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

Intervention

Drug:
• PEG-rhG-CSF
Patients will be given PEG-rhG-CSF for primary/secondary prevention each cycle.
• rhG-CSF
Patients will be given rhG-CSF for either primary/secondary prevention or treatment once any neutropenia each cycle.

Locations

Country	Name	City	State
China	Ruijin hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Ruijin Hospital

Country where clinical trial is conducted

China, 

Outcome

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