PEG-rhG-CSF in Patients With Non-Hodgkin Lymphoma Receiving Chemotherapy to Prevent Neutropenia
- Conditions
- Lymphoma,Non-Hodgkin
- Interventions
- Drug: Pegylated rhG-CSF regimen
- Registration Number
- NCT02996617
- Lead Sponsor
- Shandong Provincial Hospital
- 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. The PEG-rhG-CSF has increased plasma half-life, and prolonged efficacy in compare with rhG-CSF. The purpose of this study is to determine the safety and effectiveness of PEG-rhG-CSF in preventing neutropenia following chemotherapy in patients with non-Hodgkin lymphoma.
- Detailed Description
Neutropenia is a common clinical complication of chemotherapy in cancer patients. It is an important factor that delays the course of standard treatments in patients. Recombinant human granulocyte colony-stimulating factor (rhG-CSF) is an effective drug for the treatment of chemotherapy-induced neutropenia. However, for patients with neutropenia, multiple rhG-CSF treatments are usually required. This is likely to extend the antitumor treatment period and increase physical and mental stress in patients. Pegylated recombinant human granulocyte colony-stimulating factor (PEG-rhG-CSF) is rhG-CSF chemically modified by a single methoxy polyethylene glycol group; it is able to alleviate neutropenia with a single dose. The aim of the present study was to determine the safety and effectiveness of preventive treatment with pegylated recombinant human granulocyte colony stimulating factor (PEG-rhG-CSF) on concurrent chemotherapy-induced neutropenia and to provide a rational basis for its clinical application. Therefore, the investigators designed the multi-center, open-label,randomized controlled clinical study and aimed to compare the efficacy and safety between PEG-rhG-CSF and rhG-CSF in non-Hodgkin lymphoma receiving chemotherapy.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 240
- Investigator diagnosis of non-Hodgkin lymphoma(Highly invasive lymphoma/Burkitt lymphoma were excluded)
- Age 18 to 80 years
- ECOG performance status ≤ 2
- receive multi-cycle Chemotherapy naive
- grade 3/4 neutropenia occurred in the patient's first cycle chemotherapy or the risk of neutropenia >20% without rhG-CSF support
- Expected survival time≥3 months; cNormal bone marrow function(absolute neutrophil count ≥1.5 × 109/L; platelet count ≥ 80 × 109/L)
- Liver function: transaminase≤2.5× upper limit of normal value，bilirubin≤2.5×upper limit of normal value; serum creatinine≤2×upper limit of normal value;
- Patients with severe complications or severe infection;
- Invasion of central nervous system;
- Patients with severe visceral organ dysfunction, heart block, myocardial infarction within 6 months;
- Prior bone marrow stem cell or organ transplantation
- patients with severe allergic constitution, or those who are allergic to Escherichia coli products; 5. Patients participate in other clinical studies within 4 weeks;
- Pregnancy, lactation
- Other patients who are not suitable for the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Pegylated rhG-CSF regimen Pegylated rhG-CSF regimen Patients were administered pegylated rhG-CSF 6mg（weight≥45Kg）or 3mg（weight≤45Kg）once 24 hours after the end of chemotherapy drugs of every chemotherapy cycle for total 4 courses. rhG-CSF regimen rhG-CSF regimen Patients weren't preventive use of rhG-CSF（ruibai 100ug）.If their WBC≤1×10\^ 9/L,they were administered rhG-CSF:5ug/kg/day until their WBC≥4×10\^ 9/L for total 4 courses.
- Primary Outcome Measures
Name Time Method Rate of grade 3/4 neutropenia（neutrophils≤1×10^ 9/L） in every cycle through the study completion,an average of 4 months Proportion of patients grade 3/4 neutropenia（neutrophils≤1×10\^ 9/L）
- Secondary Outcome Measures
Name Time Method Rate of the chemotherapy delay through the study completion,an average of 4 months Proportion of chemotherapy delay(\>7 days) caused by neutropenia
Rate of the febrile neutropenia in every cycle through the study completion,an average of 4 months Proportion of febrile caused by neutropenia
Trial Locations
- Locations (1)
Department of Hematology, Provincial Hospital Affiliated to Shandong University
🇨🇳Jin'an, Shandong, China