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

Phase 4

• Conditions: Lymphoma, Non-Hodgkin; Granulocyte Colony-Stimulating Factor; Cost-Benefit Analysis
• Interventions: Drug: rhG-CSF; Drug: PEG-rhG-CSF

• Registration Number: NCT04083079
• Lead Sponsor: Ruijin Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-08-01
• Study First Submitted: 2019-08-26
• Status Verified: 2019-09
• Study First Submitted QC: 2019-09-05
• Last Update Submitted: 2019-09-05
• Study First Posted: 2019-09-10
• Last Update Posted: 2019-09-10
• Primary Completion: 2021-08-01
• Study Completion: 2022-04-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 250

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
rhG-CSF cohort	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
PEG-rhG-CSF cohort	PEG-rhG-CSF	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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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
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
Relative dosage intensity	1 year	comparison between planned and actual chemotherapy dosage in each cycle
Adverse events	1 year	incidence and severity of adverse events during study period
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
Usage rate of antibiotics	1 year	Usage rate of antibiotics during study period
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

Trial Locations

Locations (1)

Ruijin hospital; 🇨🇳 Shanghai, Shanghai, China