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

NCT03701841 | Unknown

• 1 other identifier: AHP-PSPRWS
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Chemotherapy-induced Neutropenia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Incidence of 3-4 grade of neutropenia

  through study completion, an average of 2 year

• FN-related hospitalization and antibiotic use

  through study completion, an average of 2 year

Study Arms (2)

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

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

Interventions

PEG-rhG-CSF DRUG

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 primary prophylaxis; PEG-rhG-CSF secondary prophylaxis

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Anhui Provincial Hospital: lead

Study Sites (1)

Anhui Provincial cancer center

Hefei, Anhui, 230001, China

Location

MeSH Terms

Interventions

pegylated granulocyte colony-stimulating factor

Central Study Contacts

Yueyin Pan, PhD

CONTACT

86-551-62283411; yueyinpan1965@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: September 27, 2018
• First Posted: October 10, 2018
• Study Start: October 1, 2018
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: October 10, 2018

Record last verified: 2018-10

Locations

CN (1)