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

NCT02996617 | Unknown Phase 4

• 1 other identifier: ShandongPH02
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Lymphoma,Non-Hodgkin

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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）

  through the study completion,an average of 4 months

Secondary Outcomes (2)

• Rate of the chemotherapy delay

  through the study completion,an average of 4 months

• Rate of the febrile neutropenia in every cycle

  through the study completion,an average of 4 months

Study Arms (2)

rhG-CSF regimen

ACTIVE COMPARATOR

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.

Drug: rhG-CSF regimen

Pegylated rhG-CSF regimen

EXPERIMENTAL

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.

Drug: Pegylated rhG-CSF regimen

Interventions

rhG-CSF regimen 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

Also known as: Pegylated rhG-CSF regimen

rhG-CSF regimen

Pegylated rhG-CSF regimen 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

Pegylated rhG-CSF regimen

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shandong Provincial Hospital: lead

Study Sites (1)

Department of Hematology, Provincial Hospital Affiliated to Shandong University

Jin'an, Shandong, 250012, China

RECRUITING

Related Publications (7)

• Green MD, Koelbl H, Baselga J, Galid A, Guillem V, Gascon P, Siena S, Lalisang RI, Samonigg H, Clemens MR, Zani V, Liang BC, Renwick J, Piccart MJ; International Pegfilgrastim 749 Study Group. A randomized double-blind multicenter phase III study of fixed-dose single-administration pegfilgrastim versus daily filgrastim in patients receiving myelosuppressive chemotherapy. Ann Oncol. 2003 Jan;14(1):29-35. doi: 10.1093/annonc/mdg019.

  PMID: 12488289 BACKGROUND

• Holmes FA, Jones SE, O'Shaughnessy J, Vukelja S, George T, Savin M, Richards D, Glaspy J, Meza L, Cohen G, Dhami M, Budman DR, Hackett J, Brassard M, Yang BB, Liang BC. Comparable efficacy and safety profiles of once-per-cycle pegfilgrastim and daily injection filgrastim in chemotherapy-induced neutropenia: a multicenter dose-finding study in women with breast cancer. Ann Oncol. 2002 Jun;13(6):903-9. doi: 10.1093/annonc/mdf130.

  PMID: 12123336 BACKGROUND

• Johnston E, Crawford J, Blackwell S, Bjurstrom T, Lockbaum P, Roskos L, Yang BB, Gardner S, Miller-Messana MA, Shoemaker D, Garst J, Schwab G. Randomized, dose-escalation study of SD/01 compared with daily filgrastim in patients receiving chemotherapy. J Clin Oncol. 2000 Jul;18(13):2522-8. doi: 10.1200/JCO.2000.18.13.2522.

  PMID: 10893282 BACKGROUND

• Hadji P, Kostev K, Schroder-Bernhardi D, Ziller V. Cost comparison of outpatient treatment with granulocyte colony-stimulating factors (G-CSF) in Germany. Int J Clin Pharmacol Ther. 2012 Apr;50(4):281-9. doi: 10.5414/cp201633.

  PMID: 22456299 BACKGROUND

• Wen TJ, Wen YW, Chien CR, Chiang SC, Hsu WW, Shen LJ, Hsiao FY. Cost-effectiveness of granulocyte colony-stimulating factor prophylaxis in chemotherapy-induced febrile neutropenia among breast cancer and Non-Hodgkin's lymphoma patients under Taiwan's national health insurance system. J Eval Clin Pract. 2017 Apr;23(2):288-293. doi: 10.1111/jep.12597. Epub 2016 Aug 4.

  PMID: 27491287 BACKGROUND

• Shi YK, Chen Q, Zhu YZ, He XH, Wang HQ, Jiang ZF, Chang JH, Liu YP, Wang AL, Luo DY, Zhang Y, Ke XY, Li WL, Zhang WJ, Wang XW, Zhang YP, Wang JM, Liu XQ. Pegylated filgrastim is comparable with filgrastim as support for commonly used chemotherapy regimens: a multicenter, randomized, crossover phase 3 study. Anticancer Drugs. 2013 Jul;24(6):641-7. doi: 10.1097/CAD.0b013e3283610b5d.

  PMID: 23571496 BACKGROUND

• Molineux G. Pegylation: engineering improved pharmaceuticals for enhanced therapy. Cancer Treat Rev. 2002 Apr;28 Suppl A:13-6. doi: 10.1016/s0305-7372(02)80004-4.

  PMID: 12173407 BACKGROUND

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin; Lymphoma, B-Cell; Lymphoma, T-Cell; Neutropenia

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Agranulocytosis; Leukopenia; Cytopenia; Hematologic Diseases; Leukocyte Disorders

Study Officials

• xin wang, MD, PHD

  Shandong Provincial Hospital

  STUDY CHAIR

Central Study Contacts

xin wang, MD, PHD

CONTACT

86-531-68778331; xinw007@126.com

changqing zhen, MD

CONTACT

86-531-68778331; zcq1521@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Hematology

Study Record Dates

• First Submitted: November 19, 2016
• First Posted: December 19, 2016
• Study Start: November 1, 2016
• Primary Completion: November 1, 2018
• Study Completion: December 1, 2018
• Last Updated: December 19, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)