Efficacy, Safety and Cost-effectiveness of PEG-rhG-CSF for Primary vs Secondary Prophylaxis

• Conditions: Chemotherapy-induced Neutropenia
• Interventions: Drug: PEG-rhG-CSF

• Registration Number: NCT03701841
• Lead Sponsor: Anhui Provincial Hospital

Brief Summary

This trial is a multicenter, non-interventional, registered real-world clinical study. Based on available evidence and recommendations of guidelines, tumor patients with high risk of FN and eligible for all enrollment criteria were recruited into primary prophylaxis of PEG-rhG-CSF or secondary prophylaxis of PEG-rhG-CSF according to the real-world clinical pathway without randomization. All patients need to receive at least 2 cycles of PEG-rhG-CSF prophylaxis. Researchers will record the incidence of FN, RDI, FN-related hospitalization, antibiotic use, direct medical care and indirect medical care cost under the real clinical conditions, and assess the efficacy, safety and cost-effectiveness of PEG-rhG-CSF primary prophylaxis versus secondary prophylaxis through sub-group analysis and exploratory research.

Detailed Description

Patients with cancer planning for chemotherapy assessed with high risk of febrile neutropenia (FN) according to NCCN and ASCO guidelines are recruited, receiving primary or secondary prophylaxis of PEG-rhG-CSF according to real-world clinical pathway in local cancer center for at least 4 cycles of chemotherapy. The primary outcome is the incidence of FN rate and proportion of patients completing chemotherapy on schedule, the second outcomes are the incidence of 3-4 grade of neutropenia, FN-related hospitalization and antibiotic use, incidence of reduction and delay of chemotherapy dose, safety and pharmacoeconomics of PEG-rhG-CSF.

Study Timeline

• Study First Submitted: 2018-09-27
• Status Verified: 2018-10
• Study Start: 2018-10
• Study First Submitted QC: 2018-10-09
• Last Update Submitted: 2018-10-09
• Study First Posted: 2018-10-10
• Last Update Posted: 2018-10-10
• Primary Completion: 2020-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

1. Before the start of the study, all patients have been fully understood the research and the must sign the informed consent
2. Aged 13 years or older
3. accept at least 4 cycles of chemotherapy
4. ECOG PS 0-2
5. expected survival time ≥ 3 months
6. with -high risk of FN according to researchers

Exclusion Criteria

1. accepted stem cell or bone marrow transplant
2. undergoing any other clinical trial
3. uncontrolled infection, temperature≥38℃
4. per-week scheme chemotherapy
5. severe and uncontrolled diabetes
6. People with allergic diseases or allergies, or who are allergic to this or other genetically engineered Escherichia coli-derived biological products
7. Suspected or confirmed drug use, drug abuse, alcoholics
8. Severe mental or neurological disorders affecting informed consent and/or adverse effect presentation or observation
9. Severe heart, kidney, liver and other important organs chronic diseases
10. Pregnancy or lactation in women or women with gestation detection positive before the first time using drug
11. Patients who have fertility but are unwilling to receive contraception or partners are not willing to accept contraceptives
12. The investigator believes that the patient's condition is not suitable for this clinical study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PEG-rhG-CSF primary prophylaxis	PEG-rhG-CSF	Patients receiving chemotherapy who have a overall FN risk \>=20% receive PEG-rhG-CSF for primary prophylaxis
PEG-rhG-CSF secondary prophylaxis	PEG-rhG-CSF	Patients receiving chemotherapy who had FN or dose-limited neutropenia receive PEG-rhG-CSF for secondary prophylaxis

Primary Outcome Measures

Name	Time	Method
Incidence of FN rate	through study completion, an average of 2 year	FN was defined as fever \>=38.3°C orally (\>=38.0°C for a duration over 2h) or axillary temperature \>=38.1°C (\>=37.8°C for a duration over 2h) and ANC \< 0.5 X 10\*9/L
Proportion of patients completing chemotherapy on schedule	through study completion, an average of 2 year	proportion of patients completing chemotherapy on schedule

Secondary Outcome Measures

Name	Time	Method
Incidence of 3-4 grade of neutropenia	through study completion, an average of 2 year	the second outcomes are the incidence of 3-4 grade of neutropenia
FN-related hospitalization and antibiotic use	through study completion, an average of 2 year	FN-related hospitalization and antibiotic use

Trial Locations

Locations (1)

Anhui Provincial cancer center; 🇨🇳 Hefei, Anhui, China