Back to resultsEvaluate the Efficacy and Safety of PEG-rhG-CSF in Preventing Neutropenia After Chemotherapy in Patients With Non-Hodgkin's Lymphoma
Primary Purpose
Non Hodgkin's Lymphoma
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
PEG-rhG-CSF
Sponsored by
About this trial
This is an interventional prevention trial for Non Hodgkin's Lymphoma
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 18 years, gender is not limited;
- Patients with lymphoma diagnosed by histopathology or cytology;
- Patients requiring multi-cycle chemotherapy;
- Planned chemotherapy regimen FN risk ≥ 20 % , or 10% <FN risk < 20% with high risk factors ; According to the judgment of the investigator, there is a risk of FN occurrence if G-CSF support is not accepted, PEG-rhG-CSF should be used prophylactically from the first cycle;
- Physical status (KPS) score ≥ 70 points;
- Expected Survival period of more than 3 months;
- Normal bone marrow hematopoietic function (ANC ≥1.5×10^9/L, PLT≥80×10^9/L, Hb≥75g/L, WBC≥3.0×10^9/L);
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST)≤2.5 times the upper limit of normal value, or≤5 times the upper limit of normal value when there is liver metastasis; total bilirubin (TBIL)≤2.5 times the upper limit of normal value; serum creatinine (Cr)≤2 times the upper limit of normal value;
- Female patients of childbearing age must be negative in urine pregnancy test before treatment;
- The testers (or their legal representatives/guardians) must sign an informed consent form.
Exclusion Criteria:
- Lymphoma central involvement;
- Hematopoietic stem cell transplantation or organ transplantation;
- Local or systemic infection without adequate control;
- Severe internal organ dysfunction and occurred in the last 6 months Myocardial infarction;
- Those who used other test drugs of the same kind or accepted other clinical trials within 4 weeks before enrollmen；
- Allergy to PEG-rhG-CSF, rhG-CSF and other preparations or proteins expressed by Escherichia coli;
- Severe mental illness, affecting informed consent and/or adverse reaction expression or observation;
- Pregnant or lactating female patients; women who refuse to accept contraceptive measures ;
- Researchers determine unsuited to participate in this trial.
Sites / Locations
- The fourth hospital of Hebei Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PEG-rhG-CSF group
Arm Description
Patients received subcutaneous injection of PEG-rhG-CSF(Jinyouli®) 48 hours after the end of chemotherapy, 6mg for patients with body weight≥45kg and 3mg for patients with body weight less than 45kg, once per chemotherapy cycle
Outcomes
Primary Outcome Measures
The incidence of grade Ⅲ/Ⅳ neutropenia
Grade Ⅲ neutropenia is defined as ANC≥0.5×10^9/L, and <1×10^9/L; Grade Ⅳ neutropenia is defined as ANC<0.5×10^9/L
Secondary Outcome Measures
Incidence of febrile neutropenia (FN)
A single oral temperature is 38.3℃ or ≥38℃ for more than 1 h, and the absolute value of neutrophils is less than 0.5×10^9/L or the absolute value of neutrophils is less than 1.0×10^9/L but it is expected to drop to less than 0.5×10^9/L within 48 hours
Antibiotic use rate
Antibiotic use rate during the treatment cycle
Incidence of dose adjustment of chemotherapy or delay of chemotherapy
Dose adjustment is defined as the reduction of planned dose of chemotherapy; Chemotherapy delay is defined as the delay in starting the next planned chemotherapy for more than 3 days.
Full Information
NCT ID
NCT04497688
First Posted
July 27, 2020
Last Updated
August 2, 2020
Sponsor
CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
Collaborators
Hebei Medical University Fourth Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04497688
Brief Title
Evaluate the Efficacy and Safety of PEG-rhG-CSF in Preventing Neutropenia After Chemotherapy in Patients With Non-Hodgkin's Lymphoma
Official Title
A Multi-center, Open-label, Single-arm Study to Evaluate the Efficacy and Safety of PEG-rhG-CSF(Jinyouli®) in Preventing Neutropenia After Chemotherapy in Patients With Non-Hodgkin's Lymphoma
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
September 1, 2020 (Anticipated)
Study Completion Date
October 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
Collaborators
Hebei Medical University Fourth Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The main treatments for non-Hodgkin's lymphoma are surgery, radiotherapy, chemotherapy, and bone marrow transplantation. Neutropenia is the most common and serious complication of most chemotherapy. This study is a multi-center, open-label, single-arm clinical study to evaluate the efficacy and safety of jinyouli in preventing neutropenia in patients with non Hodgkin's lymphoma after chemotherapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Hodgkin's Lymphoma
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
104 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PEG-rhG-CSF group
Arm Type
Experimental
Arm Description
Patients received subcutaneous injection of PEG-rhG-CSF(Jinyouli®) 48 hours after the end of chemotherapy, 6mg for patients with body weight≥45kg and 3mg for patients with body weight less than 45kg, once per chemotherapy cycle
Intervention Type
Drug
Intervention Name(s)
PEG-rhG-CSF
Intervention Description
Patients received a single dose of PEG-rhG-CSF per cycle. The chemotherapy regimen must meet the interval between two chemotherapy sessions at least 12 days.
Primary Outcome Measure Information:
Title
The incidence of grade Ⅲ/Ⅳ neutropenia
Description
Grade Ⅲ neutropenia is defined as ANC≥0.5×10^9/L, and <1×10^9/L; Grade Ⅳ neutropenia is defined as ANC<0.5×10^9/L
Time Frame
From date of randomization until the date of the study completion，up to 24 weeks
Secondary Outcome Measure Information:
Title
Incidence of febrile neutropenia (FN)
Description
A single oral temperature is 38.3℃ or ≥38℃ for more than 1 h, and the absolute value of neutrophils is less than 0.5×10^9/L or the absolute value of neutrophils is less than 1.0×10^9/L but it is expected to drop to less than 0.5×10^9/L within 48 hours
Time Frame
From date of randomization until the date of the study completion，up to 24 weeks
Title
Antibiotic use rate
Description
Antibiotic use rate during the treatment cycle
Time Frame
From date of randomization until the date of the study completion，up to 24 weeks
Title
Incidence of dose adjustment of chemotherapy or delay of chemotherapy
Description
Dose adjustment is defined as the reduction of planned dose of chemotherapy; Chemotherapy delay is defined as the delay in starting the next planned chemotherapy for more than 3 days.
Time Frame
From date of randomization until the date of the study completion，up to 24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥ 18 years, gender is not limited;
Patients with lymphoma diagnosed by histopathology or cytology;
Patients requiring multi-cycle chemotherapy;
Planned chemotherapy regimen FN risk ≥ 20 % , or 10% <FN risk < 20% with high risk factors ; According to the judgment of the investigator, there is a risk of FN occurrence if G-CSF support is not accepted, PEG-rhG-CSF should be used prophylactically from the first cycle;
Physical status (KPS) score ≥ 70 points;
Expected Survival period of more than 3 months;
Normal bone marrow hematopoietic function (ANC ≥1.5×10^9/L, PLT≥80×10^9/L, Hb≥75g/L, WBC≥3.0×10^9/L);
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST)≤2.5 times the upper limit of normal value, or≤5 times the upper limit of normal value when there is liver metastasis; total bilirubin (TBIL)≤2.5 times the upper limit of normal value; serum creatinine (Cr)≤2 times the upper limit of normal value;
Female patients of childbearing age must be negative in urine pregnancy test before treatment;
The testers (or their legal representatives/guardians) must sign an informed consent form.
Exclusion Criteria:
Lymphoma central involvement;
Hematopoietic stem cell transplantation or organ transplantation;
Local or systemic infection without adequate control;
Severe internal organ dysfunction and occurred in the last 6 months Myocardial infarction;
Those who used other test drugs of the same kind or accepted other clinical trials within 4 weeks before enrollmen；
Allergy to PEG-rhG-CSF, rhG-CSF and other preparations or proteins expressed by Escherichia coli;
Severe mental illness, affecting informed consent and/or adverse reaction expression or observation;
Pregnant or lactating female patients; women who refuse to accept contraceptive measures ;
Researchers determine unsuited to participate in this trial.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lihong Liu, PHD
Phone
86-13831177920
Email
13831177920@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lihong Liu, PHD
Organizational Affiliation
The Fourth Hospital of Hebei Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The fourth hospital of Hebei Medical University
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050019
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lihong Liu, PHD
Phone
86-13831177920
Email
13831177920@163.com
12. IPD Sharing Statement
Learn more about this trial
Evaluate the Efficacy and Safety of PEG-rhG-CSF in Preventing Neutropenia After Chemotherapy in Patients With Non-Hodgkin's Lymphoma
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