Clinical trial NCT01627990: Nivestim™ in Treatment of Malignant Diseases
Official title: The Compatibility of Nivestim™ Under Cytotoxic Chemotherapy in the Treatment of Malignant Diseases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Solid Tumour
Malignant Haematological Tumour
Primary or Secondary Prophylactic Treatment
Keywords: cytotoxic chemotherapy
G-CSF
Solid tumour
Malignant haematological tumour
Lead sponsor: Hospira, now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2012-06-26
Enrollment: 386
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children and adult patients with a solid tumour or a malignant haematological tumour

Brief summary: The purpose of this study is to observe the tolerability, safety and efficacy of preventative treatment using Nivestim™ in patients receiving cytotoxic chemotherapy for cancer.

Detailed description: This is a non-interventional, descriptive, national, multi-site, longitudinal and prospective observational study with in-patients adults or minors undergoing cytotoxic chemotherapy, being treated prophylactically with Nivestim™ in order to reduce the duration of neutropenia and to reduce the incidence of chemotherapy-induced Febrile neutropenia (FN).

Eligibility criteria: Inclusion Criteria:

* No age limit
* Declaration of informed consent signed by patient or legal guardian
* Patients with a solid tumour or with a malignant haematological tumour
* Patients for whom cytotoxic chemotherapy is planned, irrespective of cycle
* Patients who are due to undergo, or who should undergo, (primary or secondary) prophylactic treatment using Nivestim™, either to shorten the duration of a neutropenia or to prevent the occurrence of chemotherapy induced febrile neutropenia (FN).

Exclusion Criteria:

* Patients with chronic myeloid leukaemia (CML) or with myelodysplastic Syndrome (MDS)
* Patients who are hypersensitive to the active substance or to one of the excipients of Nivestim™
* Patients not undergoing chemotherapy
* Patients being treated curatively with Granulocyte-Colony Stimulating Factor (G-CSF)

Primary outcomes:
measure: Incidence of hospitalisation due to febrile neutropenia and/or infection
timeFrame: 6 months
Secondary outcomes:
measure: Characterisation of patients being treated with Nivestim™
timeFrame: 6 months
measure: Treatment with Nivestim™ as part of daily routine
timeFrame: 6 months
measure: Description of the efficacy of treatment with Nivestim™
timeFrame: 6 months
measure: Detailed description of tolerability and safety
timeFrame: 6 months
measure: Description of the characteristics of the participating physicians
timeFrame: During the study initiation visit
measure: Prescription routine of G-CSF (Granulocyte Colony-Stimulating Factor)
timeFrame: During the study initiation visit
Other outcomes:
Locations:
city: Ahaus
country: Germany
facility: Facharzt für Innere Medizin, Onkologie, Hämatologie
city: Aschaffenburg
country: Germany
facility: Studienzentrum Hämatologie/Onkologie/Diabetologie
city: Bad Säckingen
country: Germany
facility: Facharzt für Innere Medizin Hämatologie / Onkologie
city: Berlin
country: Germany
facility: MediOnko-Institut GbR
city: Berlin
country: Germany
facility: Onkoplan GmbH/Onkologische Schwerpunkpraxis
city: Chemnitz
country: Germany
facility: FA f. Frauenheilkunde und Geburtshilfe Gynäkologische Onkologie
city: Delitzsch
country: Germany
facility: MVZ Delitzsch GmbH
city: Dortmund
country: Germany
facility: Gesellschaft für onkologische Studien Dortmund mbH
city: Dresden
country: Germany
facility: Gemeinschaftspraxis
city: Düsseldorf
country: Germany
facility: Gemeinschaftspraxis Haematologie/Medizin Onkologie
city: Eisenach
country: Germany
facility: Gemeinschaftspraxis
city: Frankfurt/Main
country: Germany
facility: Krankenhaus Nordwest GmbH Institut für klinische Forschung
city: Garbsen
country: Germany
facility: Internist - Hämatologe - Onkologe
city: Gütersloh
country: Germany
facility: Onkodok GmbH
city: Hamburg
country: Germany
facility: Fachärztin für Allgemeinmedizin
city: Hamburg
country: Germany
facility: Facharzt für innere Medizin
city: Hannover
country: Germany
facility: Internist - Hämatologe - Onkologe
city: Heidenheim
country: Germany
facility: ODZ-Petersen GmbH
city: Herne
country: Germany
facility: DOKUSAN Gesellschaft für medizinische Studien mbH & Co. KG
city: Krefeld
country: Germany
facility: ZAGO
city: Leipzig
country: Germany
facility: FA f. Frauenheilkunde und Geburtshilfe
city: Leipzig
country: Germany
facility: Pneumologisch/onkologisch/internistisches Studienzentrum
city: Lippstadt
country: Germany
facility: Fachübergreifende Gemeinschaftspraxis Innere Medizin, Hämatologie, Onkologie, Tumortherapie, Palliativmedizin
city: Mainz
country: Germany
facility: Praxis für Innere Medizin, Hämatologie und Onkologie
city: Minden
country: Germany
facility: Johannes Esling Klinikum Minden
city: Moers
country: Germany
facility: OnkoLog Moers GbR
city: Munchen
country: Germany
facility: Fachärzte für Innere Medizin - Hämatologie u. Internistische Onkologie - Bluttransfusionswesen
city: München
country: Germany
facility: Forschungs- und Studiengesellschaft HOPE München GmbH
city: Münster
country: Germany
city: Neustadt a. Rbge
country: Germany
facility: FÄ für Innere Medizin Hämatologie/Internistische Onkologie
city: Neustadt/Sachsen
country: Germany
facility: Facharzt für Innere Medizin - Medikamentöse Tumortherapie - Palliativmedizin
city: Nordhausen
country: Germany
facility: MVZ Nordhausen gGmbH/ FA für Frauenheilkunde und Geburtshilfe
city: Nürnberg
country: Germany
facility: Martha-Maria Krankenhaus gGmbH MVZ Onkologie
city: Oelde
country: Germany
facility: Fachärztin für Innere Medizin Hämatologie u. Internistische Onkologie
city: Oldenburg
country: Germany
facility: Onkologische Praxis Oldenburg/ Delmenhorst
city: Olpe
country: Germany
facility: Medizinisches Versorgungszentrum Onkologische Schwerpunktpraxis
city: Osnabrück
country: Germany
city: Remscheid
country: Germany
facility: Facharzt für Innere Medizin - Hämatologie - Onkologie - Medikamentöse Tumortherapie
city: Rodgau
country: Germany
facility: Frauenärzte -Naturheilverfahren-
city: Scheibenberg
country: Germany
facility: Facharzt für Fraueneheilkunde und Geburtshilfe Gynäkologische Onkologie
city: Siegburg
country: Germany
facility: Onkol. Managementgesellschaft Bonn/Rhein-Sieg/Ahr mbH
city: Soest-Paradiese
country: Germany
facility: Medizinisches Versorgungszentrum GbR
city: Stralsund
country: Germany
facility: g.SUND Gyn. Kompetenzzentrum FA f. Frauenheilkunde & Geburtshilfe SP Gynäkologie Onkologie operative Gyn./ med. Tumortherapie/ Palliativmed.
city: Stuttgart
country: Germany
city: Velbert
country: Germany
facility: Fachärzte für Innere Medizin -Hämatologie und Internistische Onkologie
city: Wiesbaden
country: Germany
facility: Gesellschaft zur Förderung von Wissenschaft und Qualitätssicherung in der ambulanten Onkologie (GFWQ)
city: Witten
country: Germany
facility: FA f. Frauenheilkunde u. Geburtshilfe Marien-Hospital Witten gGmbH
city: Zittau
country: Germany
facility: FA für innere Medizin/Hämatologie und Int. Onkologie/Palliativmedizin
Study officials:
References:
citation: Fruehauf S, Otremba B, Stotzer O, Rudolph C. Compatibility of Biosimilar Filgrastim with Cytotoxic Chemotherapy during the Treatment of Malignant Diseases (VENICE): A Prospective, Multicenter, Non-Interventional, Longitudinal Study. Adv Ther. 2016 Nov;33(11):1983-2000. doi: 10.1007/s12325-016-0419-1. Epub 2016 Oct 14.
citation: Kamioner D, Fruehauf S, Maloisel F, Cals L, Lepretre S, Berthou C. Study design: two long-term observational studies of the biosimilar filgrastim Nivestim (Hospira filgrastim) in the treatment and prevention of chemotherapy-induced neutropenia. BMC Cancer. 2013 Nov 16;13:547. doi: 10.1186/1471-2407-13-547.