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

Chemotherapy-induced Neutropenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03701841
• Other study ID #: AHP-PSPRWS
• Status: Not yet recruiting
• Start date: October 2018
• Est. completion date: December 2020

Study information

• Verified date: October 2018
• Source: Anhui Provincial Hospital
• Contact: Yueyin Pan, PhD
• Phone: 86-551-62283411
• Email: yueyinpan1965[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chemotherapy-induced Neutropenia
• Neutropenia

Intervention

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

Locations

Country	Name	City	State
China	Anhui Provincial cancer center	Hefei	Anhui

Sponsors (1)

Lead Sponsor	Collaborator
Anhui Provincial Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Proportion of patients completing chemotherapy on schedule	proportion of patients completing chemotherapy on schedule	through study completion, an average of 2 year
Secondary	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
Secondary	FN-related hospitalization and antibiotic use	FN-related hospitalization and antibiotic use	through study completion, an average of 2 year