PEG-rhG-CSF in Patients With Non-Hodgkin Lymphoma Receiving Chemotherapy to Prevent Neutropenia

NCT ID: NCT02996617

Last Updated: 2016-12-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2018-12-31

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.

Conditions

Lymphoma,Non-Hodgkin

Keywords

Lymphomas Non-Hodgkin's B-Cell; Lymphomas Non-Hodgkin's T-Cell; PEG-rhG-CSF; Neutropenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

rhG-CSF regimen

Intervention Type: DRUG

Patients weren't preventive use of rhG-CSF.If their WBC≤1×10\^ 9/L,they were administered rhG-CSF:5ug/kg/day until their WBC≥4×10\^ 9/L.Chemotherapy regimen: CHOP: Epirubicin：70 mg/m2 , Cyclophosphamide：750 mg/m2, Vincristine: 1.4 mg/m2 , Prednison：100mg/d; CHOPE: Epirubicin：70 mg/m2, Cyclophosphamide：750 mg/m2,Vincristine: 1.4 mg/m2,Prednison：100mg/d,Etoposide: 100 mg/（m2•d）;EPOCH:etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin;Hyper-CVAD(A):hyperfractionated cyclophosphamide, vincristine,doxorubicin, dexamethasone, cytarabine and methotrexate;GemOx-R:Gemcitabine, Oxaliplatin;GDP:gemcitabine, dexamethasone, and cisplatin

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.

Group Type: EXPERIMENTAL

Pegylated rhG-CSF regimen

Intervention Type: DRUG

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.Chemotherapy regimen: CHOP: Epirubicin：70 mg/m2 , Cyclophosphamide：750 mg/m2, Vincristine: 1.4 mg/m2 , Prednison：100mg/d; CHOPE: Epirubicin：70 mg/m2, Cyclophosphamide：750 mg/m2,Vincristine: 1.4 mg/m2,Prednison：100mg/d,Etoposide: 100 mg/（m2•d）;EPOCH:etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin;Hyper-CVAD(A):hyperfractionated cyclophosphamide, vincristine,doxorubicin, dexamethasone, cytarabine and methotrexate;GemOx-R:Gemcitabine, Oxaliplatin;GDP:gemcitabine, dexamethasone, and cisplatin

Interventions

rhG-CSF regimen

Patients weren't preventive use of rhG-CSF.If their WBC≤1×10\^ 9/L,they were administered rhG-CSF:5ug/kg/day until their WBC≥4×10\^ 9/L.Chemotherapy regimen: CHOP: Epirubicin：70 mg/m2 , Cyclophosphamide：750 mg/m2, Vincristine: 1.4 mg/m2 , Prednison：100mg/d; CHOPE: Epirubicin：70 mg/m2, Cyclophosphamide：750 mg/m2,Vincristine: 1.4 mg/m2,Prednison：100mg/d,Etoposide: 100 mg/（m2•d）;EPOCH:etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin;Hyper-CVAD(A):hyperfractionated cyclophosphamide, vincristine,doxorubicin, dexamethasone, cytarabine and methotrexate;GemOx-R:Gemcitabine, Oxaliplatin;GDP:gemcitabine, dexamethasone, and cisplatin

Intervention Type: DRUG

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.Chemotherapy regimen: CHOP: Epirubicin：70 mg/m2 , Cyclophosphamide：750 mg/m2, Vincristine: 1.4 mg/m2 , Prednison：100mg/d; CHOPE: Epirubicin：70 mg/m2, Cyclophosphamide：750 mg/m2,Vincristine: 1.4 mg/m2,Prednison：100mg/d,Etoposide: 100 mg/（m2•d）;EPOCH:etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin;Hyper-CVAD(A):hyperfractionated cyclophosphamide, vincristine,doxorubicin, dexamethasone, cytarabine and methotrexate;GemOx-R:Gemcitabine, Oxaliplatin;GDP:gemcitabine, dexamethasone, and cisplatin

Intervention Type: DRUG

Other Intervention Names

Pegylated rhG-CSF regimen

Eligibility Criteria

Inclusion Criteria

• 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;

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shandong Provincial Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Wang Xin

Director of Department of Hematology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

xin wang, MD, PHD

Role: STUDY_CHAIR

Shandong Provincial Hospital

Locations

Department of Hematology, Provincial Hospital Affiliated to Shandong University

Jin'an, Shandong, China

Site Status: RECRUITING

Countries

China

Central Contacts

xin wang, MD, PHD

Role: CONTACT

Phone: 86-531-68778331

Email: xinw007@126.com

changqing zhen, MD

Role: CONTACT

Phone: 86-531-68778331

Email: zcq1521@163.com

Facility Contacts

Xin Wang, MD, PHD

Role: primary

changqing zhen, MD

Role: backup

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Other Identifiers

ShandongPH02

Identifier Type: -

Identifier Source: org_study_id