The Efficacy and Safety of PEG-rhG-CSF in Neutropenia After Chemotherapy
NCT ID: NCT02905916
Last Updated: 2016-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE4
217 participants
INTERVENTIONAL
2016-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Efficacy and Safety of PEG-rhG-CSF（Pegylated Recombinant Human Granulocyte Colony Stimulating Factor)in Patients With Breast Cancer Who Were Treated With Intensive Chemotherapy
NCT02944604
Saftey and Efficacy of Pegfilgrastim in Preventing Chrmotherapy-induced Neutropenia
NCT01918241
PEG-rhG-CSF in Patients With Non-Hodgkin Lymphoma Receiving Chemotherapy to Prevent Neutropenia
NCT02996617
Efficacy and Safety of 4.5mg PEG-rhG-CSF Per Cycle in Preventing Neutropenia After Intensive Chemotherapy for Breast Cancer
NCT04009941
The Efficacy and Safety of PEG-rhG-CSF in Preventing Chemotherapy-induced Neutropenia
NCT02761460
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
PEG-rhG-CSF
PEG-rhG-CSF
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
PEG-rhG-CSF
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Breast cancer, lymphoma, bone tumor or Gynecologic tumor patients.
3. With multi-cycle chemotherapy.
4. With III/IV degree neutropenia after the last cycle of chemotherapy and plans to use the same regimen in the subsequent cycles.FN risk of the chemotherapy regimens is ≥20%，or 10%≤FN risk\<20% and has high risk factors associated with FN.
5. KPS score≥ 70.
6. Expected to survive more than 3 months.
7. No hematologic system disease and ANC≥1.5×10E9/L, PKT≥80×10E9/L, Hb≥ 75g/L, WBC≥3×10E9/L, and no bleeding tendency.
8. Written informed consent are acquired. -
Exclusion Criteria
2. With any abnormal hematopoietic function.
3. Received transplantation within 3 months.
4. Suffered from other malignant tumor or brain metastases.
5. TBIL, ALT,AST \> 2.5×ULN; if it were caused by liver metastases, TBIL, ALT,AST \>5×ULN.
6. Cr \>1.5 ×ULN.
7. Sensitive to the product or other genetically engineered biological products from Escherichia coli strains.
8. Mental or nervous system disorders.
9. Refused to accept contraceptive measures.
10. Other situations that investigators consider as contra-indication for this study.
\-
18 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Peking University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Jun Zhu
Director
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jun Zhu, MD
Role: PRINCIPAL_INVESTIGATOR
Peking University Cancer Hospital & Institute
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Peking University Cancer Hospital
Beijing, , China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CSPC-JYL-05-07
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.