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

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.

Study Overview

• Status: Unknown
• Conditions: Lymphoma, Non-Hodgkin; Granulocyte Colony-Stimulating Factor; Cost-Benefit Analysis
• Intervention / Treatment: Drug: PEG-rhG-CSF; Drug: rhG-CSF

• Study Type: Interventional
• Enrollment (Anticipated): 250
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Weili Zhao, PhD; Phone Number: 610707 +86 021 6437045; Email: zhao.weili@yahoo.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200025
      • Recruiting
      • Ruijin Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PEG-rhG-CSF cohort; 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; Patients will be given PEG-rhG-CSF for primary/secondary prevention each cycle.
Experimental: rhG-CSF cohort; 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 rhG-CSF for either primary/secondary prevention or treatment once any neutropenia each cycle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
Relative dosage intensity	comparison between planned and actual chemotherapy dosage in each cycle	1 year
Usage rate of antibiotics	Usage rate of antibiotics during study period	1 year
Adverse events	incidence and severity of adverse events during study period	1 year

Collaborators and Investigators

• Sponsor: Ruijin Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2019
• Primary Completion (Anticipated): August 1, 2021
• Study Completion (Anticipated): April 1, 2022

Study Registration Dates

• First Submitted: August 26, 2019
• First Submitted That Met QC Criteria: September 5, 2019
• First Posted (Actual): September 10, 2019

Study Record Updates

• Last Update Posted (Actual): September 10, 2019
• Last Update Submitted That Met QC Criteria: September 5, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Hematologic Diseases; Agranulocytosis; Leukopenia; Leukocyte Disorders; Lymphoma; Lymphoma, Non-Hodgkin; Neutropenia
• Other Study ID Numbers: PEG-rhG-CSF-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No