Nivestim™ in Treatment of Malignant Diseases

NCT01627990 | Completed

• 1 other identifier: VENICE
• Study Type: observational
• Target: 386
• Locations: 1 country
• Sites: 48

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.

Conditions

Solid Tumour; Malignant Haematological Tumour; Primary or Secondary Prophylactic Treatment

Keywords

cytotoxic chemotherapy; G-CSF; Solid tumour; Malignant haematological tumour

Outcome Measures

Primary Outcomes (1)

• Incidence of hospitalisation due to febrile neutropenia and/or infection

  6 months

Secondary Outcomes (6)

• Characterisation of patients being treated with Nivestim™

  6 months

• Treatment with Nivestim™ as part of daily routine

  6 months

• Description of the efficacy of treatment with Nivestim™

  6 months

• Detailed description of tolerability and safety

  6 months

• Description of the characteristics of the participating physicians

  During the study initiation visit

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Children and adult patients with a solid tumour or a malignant haematological tumour

You may qualify if:

• 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).

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hospira, now a wholly owned subsidiary of Pfizer: lead

Study Sites (48)

Facharzt für Innere Medizin, Onkologie, Hämatologie

Ahaus, 48683, Germany

Location

Studienzentrum Hämatologie/Onkologie/Diabetologie

Aschaffenburg, 63739, Germany

Location

Facharzt für Innere Medizin Hämatologie / Onkologie

Bad Säckingen, 79713, Germany

Location

MediOnko-Institut GbR

Berlin, 10367, Germany

Location

Onkoplan GmbH/Onkologische Schwerpunkpraxis

Berlin, 13055, Germany

Location

FA f. Frauenheilkunde und Geburtshilfe Gynäkologische Onkologie

Chemnitz, 09117, Germany

Location

MVZ Delitzsch GmbH

Delitzsch, 04509, Germany

Location

Gesellschaft für onkologische Studien Dortmund mbH

Dortmund, 44263, Germany

Location

Gemeinschaftspraxis

Dresden, 01307, Germany

Location

Gemeinschaftspraxis Haematologie/Medizin Onkologie

Düsseldorf, 40479, Germany

Location

Gemeinschaftspraxis

Eisenach, 99817, Germany

Location

Krankenhaus Nordwest GmbH Institut für klinische Forschung

Frankfurt am Main, 60486, Germany

Location

Internist - Hämatologe - Onkologe

Garbsen, 30827, Germany

Location

Onkodok GmbH

Gütersloh, 33332, Germany

Location

Fachärztin für Allgemeinmedizin

Hamburg, 20095, Germany

Location

Facharzt für innere Medizin

Hamburg, 22765, Germany

Location

Internist - Hämatologe - Onkologe

Hanover, 30625, Germany

Location

ODZ-Petersen GmbH

Heidenheim, 89518, Germany

Location

DOKUSAN Gesellschaft für medizinische Studien mbH & Co. KG

Herne, 44623, Germany

Location

ZAGO

Krefeld, 47805, Germany

Location

FA f. Frauenheilkunde und Geburtshilfe

Leipzig, 04107, Germany

Location

Pneumologisch/onkologisch/internistisches Studienzentrum

Leipzig, 04357, Germany

Location

Fachübergreifende Gemeinschaftspraxis Innere Medizin, Hämatologie, Onkologie, Tumortherapie, Palliativmedizin

Lippstadt, 59555, Germany

Location

Praxis für Innere Medizin, Hämatologie und Onkologie

Mainz, 55131, Germany

Location

Johannes Esling Klinikum Minden

Minden, 32429, Germany

Location

OnkoLog Moers GbR

Moers, 47441, Germany

Location

Fachärzte für Innere Medizin - Hämatologie u. Internistische Onkologie - Bluttransfusionswesen

München, 80638, Germany

Location

Forschungs- und Studiengesellschaft HOPE München GmbH

München, 81245, Germany

Location

Unknown Facility

Münster, 48149, Germany

Location

FÄ für Innere Medizin Hämatologie/Internistische Onkologie

Neustadt A. Rbge, 31535, Germany

Location

Facharzt für Innere Medizin - Medikamentöse Tumortherapie - Palliativmedizin

Neustadt/Sachsen, 01844, Germany

Location

MVZ Nordhausen gGmbH/ FA für Frauenheilkunde und Geburtshilfe

Nordhausen, 99734, Germany

Location

Martha-Maria Krankenhaus gGmbH MVZ Onkologie

Nuremberg, 90491, Germany

Location

Fachärztin für Innere Medizin Hämatologie u. Internistische Onkologie

Oelde, 59302, Germany

Location

Onkologische Praxis Oldenburg/ Delmenhorst

Oldenburg, 26121, Germany

Location

Medizinisches Versorgungszentrum Onkologische Schwerpunktpraxis

Olpe, 57462, Germany

Location

Unknown Facility

Osnabrück, 49076, Germany

Location

Facharzt für Innere Medizin - Hämatologie - Onkologie - Medikamentöse Tumortherapie

Remscheid, 42859, Germany

Location

Frauenärzte -Naturheilverfahren-

Rodgau, 63110, Germany

Location

Facharzt für Fraueneheilkunde und Geburtshilfe Gynäkologische Onkologie

Scheibenberg, 09481, Germany

Location

Onkol. Managementgesellschaft Bonn/Rhein-Sieg/Ahr mbH

Siegburg, 53721, Germany

Location

Medizinisches Versorgungszentrum GbR

Soest-Paradiese, 59494, Germany

Location

g.SUND Gyn. Kompetenzzentrum FA f. Frauenheilkunde & Geburtshilfe SP Gynäkologie Onkologie operative Gyn./ med. Tumortherapie/ Palliativmed.

Stralsund, 18435, Germany

Location

Unknown Facility

Stuttgart, 70190, Germany

Location

Fachärzte für Innere Medizin -Hämatologie und Internistische Onkologie

Velbert, 42551, Germany

Location

Gesellschaft zur Förderung von Wissenschaft und Qualitätssicherung in der ambulanten Onkologie (GFWQ)

Wiesbaden, 65191, Germany

Location

FA f. Frauenheilkunde u. Geburtshilfe Marien-Hospital Witten gGmbH

Witten, 58452, Germany

Location

FA für innere Medizin/Hämatologie und Int. Onkologie/Palliativmedizin

Zittau, 02763, Germany

Location

Related Publications (2)

• 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.

  PMID: 27743353 DERIVED

• 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.

  PMID: 24237790 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

* CD34+ cell count in peripheral blood (low/high at Visit 1) * Concentrations of haemoglobin, thrombocytes, leukocytes, neutrophil and CRP are represented across time (v1, 2 and 3)

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2012
• First Posted: June 26, 2012
• Study Start: June 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: July 24, 2015

Record last verified: 2015-07

Locations

DE (48)