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

Efficacy, Safety and Cost-effectiveness of PEG-rhG-CSF for Primary Prophylaxis Versus Secondary Prophylaxis of Chemotherapy Induced Neutropenia in Patients Receiving Chemotherapy With High-risk FN: a Real World Study

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.

Study Overview

• Status: Unknown
• Conditions: Chemotherapy-induced Neutropenia
• Intervention / Treatment: Drug: PEG-rhG-CSF

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 Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230001
      • Anhui Provincial cancer center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
PEG-rhG-CSF primary prophylaxis; Patients receiving chemotherapy who have a overall FN risk >=20% receive PEG-rhG-CSF for primary prophylaxis	Drug: PEG-rhG-CSF; All patients need to receive PEG-rhG-CSF 6mg approximately 24h or 48h after chemotherapy administration once per cycle, at least 2 cycles
PEG-rhG-CSF secondary prophylaxis; Patients receiving chemotherapy who had FN or dose-limited neutropenia receive PEG-rhG-CSF for secondary prophylaxis	Drug: PEG-rhG-CSF; All patients need to receive PEG-rhG-CSF 6mg approximately 24h or 48h after chemotherapy administration once per cycle, at least 2 cycles

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of FN rate	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	through study completion, an average of 2 year
Proportion of patients completing chemotherapy on schedule	proportion of patients completing chemotherapy on schedule	through study completion, an average of 2 year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Anhui Provincial Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2018
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: September 27, 2018
• First Submitted That Met QC Criteria: October 9, 2018
• First Posted (Actual): October 10, 2018

Study Record Updates

• Last Update Posted (Actual): October 10, 2018
• Last Update Submitted That Met QC Criteria: October 9, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Agranulocytosis; Leukopenia; Leukocyte Disorders; Neutropenia
• Other Study ID Numbers: AHP-PSPRWS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No