PEG-rhG-CSF in Patients With Non-Hodgkin Lymphoma Receiving Chemotherapy to Prevent Neutropenia
15. desember 2016 oppdatert av: Wang Xin, Shandong Provincial Hospital
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.
Studieoversikt
Status
Ukjent
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Forventet)
240
Fase
- Fase 4
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
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Shandong
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Jin'an, Shandong, Kina, 250012
- Rekruttering
- Department of Hematology, Provincial Hospital Affiliated to Shandong University
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 80 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Aktiv komparator: 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.
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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
Andre navn:
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Eksperimentell: 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.
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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
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Rate of grade 3/4 neutropenia（neutrophils≤1×10^ 9/L） in every cycle
Tidsramme: through the study completion,an average of 4 months
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Proportion of patients grade 3/4 neutropenia（neutrophils≤1×10^ 9/L）
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through the study completion,an average of 4 months
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Rate of the chemotherapy delay
Tidsramme: through the study completion,an average of 4 months
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Proportion of chemotherapy delay(>7 days) caused by neutropenia
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through the study completion,an average of 4 months
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Rate of the febrile neutropenia in every cycle
Tidsramme: through the study completion,an average of 4 months
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Proportion of febrile caused by neutropenia
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through the study completion,an average of 4 months
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Samarbeidspartnere og etterforskere
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Sponsor
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
- 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.
- 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.
- 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. Erratum In: Int J Clin Pharmacol Ther. 2012 Jul;50(7):532.
- 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.
- 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.
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. november 2016
Primær fullføring (Forventet)
1. november 2018
Studiet fullført (Forventet)
1. desember 2018
Datoer for studieregistrering
Først innsendt
19. november 2016
Først innsendt som oppfylte QC-kriteriene
15. desember 2016
Først lagt ut (Anslag)
19. desember 2016
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
19. desember 2016
Siste oppdatering sendt inn som oppfylte QC-kriteriene
15. desember 2016
Sist bekreftet
1. desember 2016
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- ShandongPH02
Plan for individuelle deltakerdata (IPD)
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Nei
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