Status:
UNKNOWN
Mecapegfilgrastim(PEG-G-CSF) for Prophylaxis of Chemotherapy-induced Neutropenia in Patients With Lymphoma
Lead Sponsor:
The First Hospital of Jilin University
Conditions:
Chemotherapy-induced Neutropenia
Lymphoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 develo...
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 filgrast...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 20 2023
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT04460508
Start Date
December 20 2020
End Date
March 20 2023
Last Update
July 7 2022
Active Locations (1)
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1
The First Bethune Hospital of Jilin University
Changchun, Jilin, China, 130021