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

Primary Purpose

Lymphoma,Non-Hodgkin

Status

Unknown status

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

rhG-CSF regimen

Pegylated rhG-CSF regimen

About this trial

This is an interventional treatment trial for Lymphoma,Non-Hodgkin focused on measuring Lymphomas Non-Hodgkin's B-Cell, Lymphomas Non-Hodgkin's T-Cell, PEG-rhG-CSF, Neutropenia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Department of Hematology, Provincial Hospital Affiliated to Shandong UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

rhG-CSF regimen

Pegylated rhG-CSF regimen

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Rate of grade 3/4 neutropenia（neutrophils≤1×10^ 9/L） in every cycle

Proportion of patients grade 3/4 neutropenia（neutrophils≤1×10^ 9/L）

Secondary Outcome Measures

Rate of the chemotherapy delay

Proportion of chemotherapy delay(>7 days) caused by neutropenia

Rate of the febrile neutropenia in every cycle

Proportion of febrile caused by neutropenia

Full Information

NCT ID

NCT02996617

First Posted

November 19, 2016

Last Updated

December 15, 2016

Sponsor

Shandong Provincial Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02996617

Brief Title

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

2. Study Status

Record Verification Date

December 2016

Overall Recruitment Status

Unknown status

Study Start Date

November 2016 (undefined)

Primary Completion Date

November 2018 (Anticipated)

Study Completion Date

December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shandong Provincial Hospital

4. Oversight

Data Monitoring Committee

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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lymphoma,Non-Hodgkin

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

rhG-CSF regimen

Arm Type

Active Comparator

Arm Description

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.

Arm Title

Pegylated rhG-CSF regimen

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

rhG-CSF regimen

Other Intervention Name(s)

Pegylated rhG-CSF regimen

Intervention Description

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

Intervention Name(s)

Pegylated rhG-CSF regimen

Intervention Description

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

Primary Outcome Measure Information:

Title

Rate of grade 3/4 neutropenia（neutrophils≤1×10^ 9/L） in every cycle

Description

Proportion of patients grade 3/4 neutropenia（neutrophils≤1×10^ 9/L）

Time Frame

through the study completion,an average of 4 months

Secondary Outcome Measure Information:

Title

Rate of the chemotherapy delay

Description

Proportion of chemotherapy delay(>7 days) caused by neutropenia

Time Frame

through the study completion,an average of 4 months

Title

Rate of the febrile neutropenia in every cycle

Description

Proportion of febrile caused by neutropenia

Time Frame

through the study completion,an average of 4 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

xin wang, MD, PHD

Phone

86-531-68778331

xinw007@126.com

First Name & Middle Initial & Last Name or Official Title & Degree

changqing zhen, MD

Phone

86-531-68778331

zcq1521@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

xin wang, MD, PHD

Organizational Affiliation

Shandong Provincial Hospital

Official's Role

Study Chair

Facility Information:

Facility Name

Department of Hematology, Provincial Hospital Affiliated to Shandong University

City

Jin'an

State/Province

Shandong

ZIP/Postal Code

250012

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Xin Wang, MD, PHD

Phone

86-531-68778331

xinw007@126.com

First Name & Middle Initial & Last Name & Degree

changqing zhen, MD

Phone

86-531-68778331

zcq1521@163.com

12. IPD Sharing Statement

Plan to Share IPD

Citations:

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12488289

Citation

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Results Reference

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Citation

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PubMed Identifier

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Citation

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Citation

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Citation

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

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