Nivestim™ in Treatment of Malignant Diseases

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hospira, Inc.
ClinicalTrials.gov Identifier:
NCT01627990
First received: June 7, 2012
Last updated: July 23, 2015
Last verified: July 2015
  Purpose

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.


Condition
Solid Tumour
Malignant Haematological Tumour
Primary or Secondary Prophylactic Treatment

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Compatibility of Nivestim™ Under Cytotoxic Chemotherapy in the Treatment of Malignant Diseases

Further study details as provided by Hospira, Inc.:

Primary Outcome Measures:
  • Incidence of hospitalisation due to febrile neutropenia and/or infection [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Characterisation of patients being treated with Nivestim™ [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

    Characterisation of patient based on:

    • Socio-demographic data
    • previous medical history (Surgical and therapeutic)
    • Tumour data
    • Chemotherapy data
    • Clinical and laboratory data preceding treatment with Nivestim™

  • Treatment with Nivestim™ as part of daily routine [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    • Therapeutic indication
    • Dosage and mode of administration
    • Duration of treatment (planned and carried through)
    • Delay in start of treatment since last chemotherapy for purposes of prophylaxis
    • Absolute Neutrophil Count (ANC) during study.

  • Description of the efficacy of treatment with Nivestim™ [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    Description of the efficacy of treatment with Nivestim(TM) which includes the following parameters:

    • Duration of neutropenia
    • Incidence of febrile neutropenia
    • Frequency of infection
    • Delay in chemotherapy cycles due to neutropenia
    • Reduction in chemotherapy doses due to neutropenia
    • Assessment of patient

  • Detailed description of tolerability and safety [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    • Hospitalisation
    • Adverse events

  • Description of the characteristics of the participating physicians [ Time Frame: During the study initiation visit ] [ Designated as safety issue: No ]
    Socio-demographic data (age, gender, field of specialisation, structure of practice, title)

  • Prescription routine of G-CSF (Granulocyte Colony-Stimulating Factor) [ Time Frame: During the study initiation visit ] [ Designated as safety issue: Yes ]
    Criteria for selecting Nivestim™


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)

Enrollment: 386
Study Start Date: June 2011
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01627990

Locations
Germany
Facharzt für Innere Medizin, Onkologie, Hämatologie
Ahaus, Germany, 48683
Studienzentrum Hämatologie/Onkologie/Diabetologie
Aschaffenburg, Germany, 63739
Facharzt für Innere Medizin Hämatologie / Onkologie
Bad Säckingen, Germany, 79713
MediOnko-Institut GbR
Berlin, Germany, 10367
Onkoplan GmbH/Onkologische Schwerpunkpraxis
Berlin, Germany, 13055
FA f. Frauenheilkunde und Geburtshilfe Gynäkologische Onkologie
Chemnitz, Germany, 09117
MVZ Delitzsch GmbH
Delitzsch, Germany, 04509
Gesellschaft für onkologische Studien Dortmund mbH
Dortmund, Germany, 44263
Gemeinschaftspraxis
Dresden, Germany, 01307
Gemeinschaftspraxis Haematologie/Medizin Onkologie
Düsseldorf, Germany, 40479
Gemeinschaftspraxis
Eisenach, Germany, 99817
Krankenhaus Nordwest GmbH Institut für klinische Forschung
Frankfurt/Main, Germany, 60486
Internist - Hämatologe - Onkologe
Garbsen, Germany, 30827
Onkodok GmbH
Gütersloh, Germany, 33332
Facharzt für innere Medizin
Hamburg, Germany, 22765
Fachärztin für Allgemeinmedizin
Hamburg, Germany, 20095
Internist - Hämatologe - Onkologe
Hannover, Germany, 30625
ODZ-Petersen GmbH
Heidenheim, Germany, 89518
DOKUSAN Gesellschaft für medizinische Studien mbH & Co. KG
Herne, Germany, 44623
ZAGO
Krefeld, Germany, 47805
FA f. Frauenheilkunde und Geburtshilfe
Leipzig, Germany, 04107
Pneumologisch/onkologisch/internistisches Studienzentrum
Leipzig, Germany, 04357
Fachübergreifende Gemeinschaftspraxis Innere Medizin, Hämatologie, Onkologie, Tumortherapie, Palliativmedizin
Lippstadt, Germany, 59555
Praxis für Innere Medizin, Hämatologie und Onkologie
Mainz, Germany, 55131
Johannes Esling Klinikum Minden
Minden, Germany, 32429
OnkoLog Moers GbR
Moers, Germany, 47441
Fachärzte für Innere Medizin - Hämatologie u. Internistische Onkologie - Bluttransfusionswesen
Munchen, Germany, 80638
Forschungs- und Studiengesellschaft HOPE München GmbH
München, Germany, 81245
Münster, Germany, 48149
FÄ für Innere Medizin Hämatologie/Internistische Onkologie
Neustadt a. Rbge, Germany, 31535
Facharzt für Innere Medizin - Medikamentöse Tumortherapie - Palliativmedizin
Neustadt/Sachsen, Germany, 01844
MVZ Nordhausen gGmbH/ FA für Frauenheilkunde und Geburtshilfe
Nordhausen, Germany, 99734
Martha-Maria Krankenhaus gGmbH MVZ Onkologie
Nürnberg, Germany, 90491
Fachärztin für Innere Medizin Hämatologie u. Internistische Onkologie
Oelde, Germany, 59302
Onkologische Praxis Oldenburg/ Delmenhorst
Oldenburg, Germany, 26121
Medizinisches Versorgungszentrum Onkologische Schwerpunktpraxis
Olpe, Germany, 57462
Osnabrück, Germany, 49076
Facharzt für Innere Medizin - Hämatologie - Onkologie - Medikamentöse Tumortherapie
Remscheid, Germany, 42859
Frauenärzte -Naturheilverfahren-
Rodgau, Germany, 63110
Facharzt für Fraueneheilkunde und Geburtshilfe Gynäkologische Onkologie
Scheibenberg, Germany, 09481
Onkol. Managementgesellschaft Bonn/Rhein-Sieg/Ahr mbH
Siegburg, Germany, 53721
Medizinisches Versorgungszentrum GbR
Soest-Paradiese, Germany, 59494
g.SUND Gyn. Kompetenzzentrum FA f. Frauenheilkunde & Geburtshilfe SP Gynäkologie Onkologie operative Gyn./ med. Tumortherapie/ Palliativmed.
Stralsund, Germany, 18435
Stuttgart, Germany, 70190
Fachärzte für Innere Medizin -Hämatologie und Internistische Onkologie
Velbert, Germany, 42551
Gesellschaft zur Förderung von Wissenschaft und Qualitätssicherung in der ambulanten Onkologie (GFWQ)
Wiesbaden, Germany, 65191
FA f. Frauenheilkunde u. Geburtshilfe Marien-Hospital Witten gGmbH
Witten, Germany, 58452
FA für innere Medizin/Hämatologie und Int. Onkologie/Palliativmedizin
Zittau, Germany, 02763
Sponsors and Collaborators
Hospira, Inc.
  More Information

No publications provided

Responsible Party: Hospira, Inc.
ClinicalTrials.gov Identifier: NCT01627990     History of Changes
Other Study ID Numbers: VENICE
Study First Received: June 7, 2012
Last Updated: July 23, 2015
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Hospira, Inc.:
cytotoxic chemotherapy
G-CSF
Solid tumour
Malignant haematological tumour

ClinicalTrials.gov processed this record on July 30, 2015