Clinical trial NCT02996617: PEG-rhG-CSF in Patients With Non-Hodgkin Lymphoma Receiving Chemotherapy to Prevent Neutropenia
Official title: PEG-rhG-CSF in Patients With Non-Hodgkin Lymphoma Receiving Chemotherapy to Prevent Neutropenia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Lymphoma,Non-Hodgkin
Keywords: Lymphomas Non-Hodgkin's B-Cell
Lymphomas Non-Hodgkin's T-Cell
PEG-rhG-CSF
Neutropenia
Lead sponsor: Shandong Provincial Hospital
Sponsor class: OTHER_GOV
First posted: 2016-12-19
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Rate of grade 3/4 neutropenia（neutrophils≤1×10^ 9/L） in every cycle
timeFrame: through the study completion,an average of 4 months
Secondary outcomes:
measure: Rate of the chemotherapy delay
timeFrame: through the study completion,an average of 4 months
measure: Rate of the febrile neutropenia in every cycle
timeFrame: through the study completion,an average of 4 months
Other outcomes:
Locations:
city: Jin'an
country: China
facility: Department of Hematology, Provincial Hospital Affiliated to Shandong University
state: Shandong
Study officials:
affiliation: Shandong Provincial Hospital
name: xin wang, MD, PHD
role: STUDY_CHAIR
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