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

Primary Purpose

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

Status

Unknown status

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

PEG-rhG-CSF

rhG-CSF

About this trial

This is an interventional treatment trial for Lymphoma, Non-Hodgkin

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Ruijin hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

PEG-rhG-CSF cohort

rhG-CSF cohort

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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.

Incidence of febrile neutropenia

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

Duration time of febrile neutropenia （i.e. absolute neutrophil count<0.5×10^9/L and temperature ≥38℃）in each cycle

Incidence of grade 3-4 neutropenia

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

Duration time of grade 3-4 neutropenia（i.e. absolute neutrophil count<1×10^9/L）in each cycle

Relative dosage intensity

comparison between planned and actual chemotherapy dosage in each cycle

Usage rate of antibiotics

Usage rate of antibiotics during study period

Adverse events

incidence and severity of adverse events during study period

Full Information

NCT ID

NCT04083079

First Posted

August 26, 2019

Last Updated

September 5, 2019

Sponsor

Ruijin Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04083079

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2019

Overall Recruitment Status

Unknown status

Study Start Date

August 1, 2019 (Actual)

Primary Completion Date

August 1, 2021 (Anticipated)

Study Completion Date

April 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ruijin Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Non-Randomized

Enrollment

250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

PEG-rhG-CSF cohort

Arm Type

Experimental

Arm Description

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

Arm Title

rhG-CSF cohort

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

PEG-rhG-CSF

Intervention Description

Patients will be given PEG-rhG-CSF for primary/secondary prevention each cycle.

Intervention Type

Drug

Intervention Name(s)

rhG-CSF

Intervention Description

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

Primary Outcome Measure Information:

Title

Incremental Cost-Effectiveness ratio

Description

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Cost-Effectiveness ratio

Description

Time Frame

1 year

Title

Sensitivity analysis

Description

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

Title

Incidence of febrile neutropenia

Description

Incidence of febrile neutropenia （i.e. absolute neutrophil count<0.5×10^9/L and temperature ≥38℃）in each cycle

Time Frame

1 year

Title

Duration time of febrile neutropenia

Description

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

Title

Incidence of grade 3-4 neutropenia

Description

Incidence of grade 3-4 neutropenia（i.e. absolute neutrophil count<1×10^9/L）in each cycle

Time Frame

1 year

Title

Duration time of grade 3-4 neutropenia

Description

Duration time of grade 3-4 neutropenia（i.e. absolute neutrophil count<1×10^9/L）in each cycle

Time Frame

1 year

Title

Relative dosage intensity

Description

comparison between planned and actual chemotherapy dosage in each cycle

Time Frame

1 year

Title

Usage rate of antibiotics

Description

Usage rate of antibiotics during study period

Time Frame

1 year

Title

Adverse events

Description

incidence and severity of adverse events during study period

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Weili Zhao, PhD

Phone

+86 021 6437045

Ext

610707

zhao.weili@yahoo.com

Facility Information:

Facility Name

Ruijin hospital

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200025

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Pengpeng XU, MD, PhD

Phone

86-21-64370045

Ext

610707

xpproc@msn.com

First Name & Middle Initial & Last Name & Degree

Weili ZHAO, MD, PhD

First Name & Middle Initial & Last Name & Degree

Pengpeng XU, MD, PhD

12. IPD Sharing Statement

Learn more about this trial

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

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