- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03701841
Efficacy, Safety and Cost-effectiveness of PEG-rhG-CSF for Primary vs Secondary Prophylaxis
October 9, 2018 updated by: Yue-Yin Pan, Anhui Provincial Hospital
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
Intervention / Treatment
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
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Yueyin Pan, PhD
- Phone Number: 86-551-62283411
- Email: yueyinpan1965@163.com
Study Locations
-
-
Anhui
-
Hefei, Anhui, China, 230001
- Anhui Provincial cancer center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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:
- 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
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
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
|
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
|
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
Time Frame: 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
|
through study completion, an average of 2 year
|
Proportion of patients completing chemotherapy on schedule
Time Frame: through study completion, an average of 2 year
|
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
Time Frame: through study completion, an average of 2 year
|
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
Time Frame: through study completion, an average of 2 year
|
FN-related hospitalization and antibiotic use
|
through study completion, an average of 2 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Chemotherapy-induced Neutropenia
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-
Hospira, now a wholly owned subsidiary of PfizerCompletedSolid Tumors | Malignant Hemopathy | Chemotherapy-induced Febrile Neutropenia (FN)France
-
Enzychem Lifesciences CorporationCompletedChemotherapy-Induced NeutropeniaKorea, Republic of
-
Enzychem Lifesciences CorporationCompletedChemotherapy-Induced NeutropeniaKorea, Republic of
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Green Cross CorporationSymyooCompleted
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Shantha Biotechnics LimitedCompletedChemotherapy-Induced NeutropeniaIndia
-
PfizerHospira, now a wholly owned subsidiary of PfizerTerminatedChemotherapy-Induced NeutropeniaFrance
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Tianjin SinoBiotech Ltd.CompletedChemotherapy-induced NeutropeniaChina
-
BeyondSpring Pharmaceuticals Inc.CompletedChemotherapy-induced NeutropeniaChina, Russian Federation, United States, Ukraine
-
Jiangsu T-Mab Biopharma Co.,LtdCompletedChemotherapy-induced NeutropeniaChina
Clinical Trials on PEG-rhG-CSF
-
Peking UniversityUnknown
-
Chongqing University Cancer HospitalCSPC Baike (Shandong) Biopharmaceutical Co., Ltd.Recruiting
-
Air Force Military Medical University, ChinaUnknown
-
Sun Yat-sen UniversityJiangsu HengRui Medicine Co., Ltd.Not yet recruiting
-
Xiamen Amoytop Biotech Co., Ltd.Cancer Institute and Hospital, Chinese Academy of Medical SciencesCompletedNon-Myeloid MalignancyChina
-
Adello Biologics, LLCinVentiv Health ClinicalCompletedHealthy VolunteersUnited States
-
CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.Hebei Medical University Fourth HospitalUnknown
-
CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.Peking University Cancer Hospital & InstituteUnknownSmall Cell Lung Cancer | PEG-rhG-CSFChina
-
CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.Beijing Friendship HospitalUnknownHemophagocytic SyndromeChina
-
Mabwell (Shanghai) Bioscience Co., Ltd.Completed