Mecapegfilgrastim(PEG-G-CSF) for Prophylaxis of Chemotherapy-induced Neutropenia in Patients With Lymphoma
Primary Purpose
Chemotherapy-induced Neutropenia, Lymphoma
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Pegylated rhG-CSF
rhG-CSF
Sponsored by
About this trial
This is an interventional prevention trial for Chemotherapy-induced Neutropenia
Eligibility Criteria
Inclusion Criteria:
- Age 18 to 75 years;
- Patients with primary malignant lymphoma confirmed by histopathology or immunomolecular biology and requiring treatment with multi-cycle high-intensity chemotherapy regimen;
- ECOG performance status ≤ 1;
- ANC ≥1.5×109/L, PLT≥80×109 /L, Hb≥ 75g/L, WBC ≥3.0×109/L;
- Subjects with pregnancy ability must agree to use reliable contraceptive measures from screening to 1 year after treatment;
- Patients must sign informed consent and be willing and able to comply with the requirements of visits, treatment, laboratory tests and other research requirements stipulated in the research schedul.
Exclusion Criteria:
- Lymphoma central involvement;
- Recipients of hematopoietic stem cell transplantation or organ transplantation;
- Currently conducting clinical trials of other drugs;
- There is an uncontrollable infection with body temperature ≥38℃;
- liver function examination: total bilirubin (TBIL., alanine aminotransferase (ALT. and ascetic aminotransferase (AST. were all 2.5 times the upper limit of the normal value of >; if they were caused by liver metastasis, the upper limit of the normal value of > was 5 times;Renal function test: serum creatinine (Cr. >2 times the upper limit of normal value
- Patients with serious chronic diseases of heart, kidney, liver and other important organs;
- Patients with severe uncontrolled diabetes;
- Pregnant or lactating female patients.
Sites / Locations
- The First Bethune Hospital of Jilin UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Mecapegfilgrastim
rhG-CSF
Arm Description
Patients were administered pegylated rhG-CSF 6mg once at the 3rd day of every chemotherapy cycle.
Patients were administered pegylated rhG-CSF 6 ug/kg/day from the 3rd day of every chemotherapy cycle.
Outcomes
Primary Outcome Measures
Duration of grade ≥3 neutropenia in cycle 1
Duration of subjects developing ANC lower than 1.0 × 109/L
Secondary Outcome Measures
Incidence of grade ≥3 neutropenia in cycle 1-4
Proportion of subjects developing ANC lower than 1.0 × 109/L from cycle 1 to cycle 4
Incidenc of febrile neutropenia (FN) in cycle 1-4
Febrile neutropenia means the ANC count is less than 1,000/mm3 and body temperature is more than 38.5 degrees celsius from cycle 1 to cycle 4
Incidence of adverse events (AEs)
Analysis of adverse events (AEs) are based on treatment-related AEs (trAEs) according to the Common Terminology Criteria for Adverse Events, version 5.0
Full Information
NCT ID
NCT04460508
First Posted
June 28, 2020
Last Updated
July 6, 2022
Sponsor
The First Hospital of Jilin University
1. Study Identification
Unique Protocol Identification Number
NCT04460508
Brief Title
Mecapegfilgrastim(PEG-G-CSF) for Prophylaxis of Chemotherapy-induced Neutropenia in Patients With Lymphoma
Official Title
Efficacy and Safety of Mecapegfilgrastim(PEG-G-CSF) for Prophylaxis of Chemotherapy-induced Neutropenia in Patients With Lymphoma: a Randomized, Open-label, Active-controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 20, 2020 (Actual)
Primary Completion Date
December 20, 2022 (Anticipated)
Study Completion Date
March 20, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The First Hospital of Jilin University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Neutropenia is one of the most frequent adverse effects of chemotherapy, and the main factor to limit the dosage and the continuation of chemotherapy.A newly pegylated rhG-CSF was independently developed by JIANGSU HENGRUI Medicine Co., Ltd, China. Phase 1a, 1b and phase 2 trials have shown that pegylated rhG-CSF has decreased renal clearance, increased plasma half-life, and prolonged efficacy in compare with filgrastim.
This study is to evaluate efficacy and safety in chemotherapy-induced neutropenia of once-per-cycle Mecapegfilgrastim Injection(PEG-G-CSF) and daily G-CSF in Patients with lymphoma patients.
Detailed Description
This is a randomized, controlled study. A total of 170 lymphoma patients who are eligible are planned to randomized assigned into two groups to receive mecapegfilgrastim fixed dose of 6 mg or filgrastim 5 µg/kg/day during chemotherapy.
The primary endpoint is the duration of grade ≥3 neutropenia in cycle 1. The secondary endpoints include incidence of grade ≥3 neutropenia and febrile neutropenia (FN) in cycle 1-4, The pharmacoeconomics and safety profile are also evaluated.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chemotherapy-induced Neutropenia, Lymphoma
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
170 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mecapegfilgrastim
Arm Type
Experimental
Arm Description
Patients were administered pegylated rhG-CSF 6mg once at the 3rd day of every chemotherapy cycle.
Arm Title
rhG-CSF
Arm Type
Active Comparator
Arm Description
Patients were administered pegylated rhG-CSF 6 ug/kg/day from the 3rd day of every chemotherapy cycle.
Intervention Type
Drug
Intervention Name(s)
Pegylated rhG-CSF
Intervention Description
Pegylated rhG-CSF:6mg
Intervention Type
Drug
Intervention Name(s)
rhG-CSF
Intervention Description
rhG-CSF:5ug/kg/d
Primary Outcome Measure Information:
Title
Duration of grade ≥3 neutropenia in cycle 1
Description
Duration of subjects developing ANC lower than 1.0 × 109/L
Time Frame
21 days
Secondary Outcome Measure Information:
Title
Incidence of grade ≥3 neutropenia in cycle 1-4
Description
Proportion of subjects developing ANC lower than 1.0 × 109/L from cycle 1 to cycle 4
Time Frame
84 days
Title
Incidenc of febrile neutropenia (FN) in cycle 1-4
Description
Febrile neutropenia means the ANC count is less than 1,000/mm3 and body temperature is more than 38.5 degrees celsius from cycle 1 to cycle 4
Time Frame
84 days
Title
Incidence of adverse events (AEs)
Description
Analysis of adverse events (AEs) are based on treatment-related AEs (trAEs) according to the Common Terminology Criteria for Adverse Events, version 5.0
Time Frame
84 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18 to 75 years;
Patients with primary malignant lymphoma confirmed by histopathology or immunomolecular biology and requiring treatment with multi-cycle high-intensity chemotherapy regimen;
ECOG performance status ≤ 1;
ANC ≥1.5×109/L, PLT≥80×109 /L, Hb≥ 75g/L, WBC ≥3.0×109/L;
Subjects with pregnancy ability must agree to use reliable contraceptive measures from screening to 1 year after treatment;
Patients must sign informed consent and be willing and able to comply with the requirements of visits, treatment, laboratory tests and other research requirements stipulated in the research schedul.
Exclusion Criteria:
Lymphoma central involvement;
Recipients of hematopoietic stem cell transplantation or organ transplantation;
Currently conducting clinical trials of other drugs;
There is an uncontrollable infection with body temperature ≥38℃;
liver function examination: total bilirubin (TBIL., alanine aminotransferase (ALT. and ascetic aminotransferase (AST. were all 2.5 times the upper limit of the normal value of >; if they were caused by liver metastasis, the upper limit of the normal value of > was 5 times;Renal function test: serum creatinine (Cr. >2 times the upper limit of normal value
Patients with serious chronic diseases of heart, kidney, liver and other important organs;
Patients with severe uncontrolled diabetes;
Pregnant or lactating female patients.
Facility Information:
Facility Name
The First Bethune Hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ou BAI, doctor
Phone
13039046656
Email
oubai16@163.com
12. IPD Sharing Statement
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Mecapegfilgrastim(PEG-G-CSF) for Prophylaxis of Chemotherapy-induced Neutropenia in Patients With Lymphoma
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