Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Nivestim(TM) in Treatment of Malignant Diseases

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Hospira, Inc.
Information provided by (Responsible Party):
Hospira, Inc. Identifier:
First received: June 7, 2012
Last updated: July 7, 2014
Last verified: July 2014

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 NivestimTM in order to reduce the duration of neutropenia and to reduce the incidence of chemotherapy-induced Febrile neutropenia (FN).

Solid Tumor
Malignant Hematological Tumor
Primary or Secondary Prophylactic Treatment

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

Further study details as provided by Hospira, Inc.:

Primary Outcome Measures:
  • Number of hospitalizations [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Any incidence of hospitalization due to febrile neutropenia and/or infection will be evaluated. Individual cases will be reported and documented on SAE forms by the repsonsible physician.

Secondary Outcome Measures:
  • Number of adverse events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Any hospitalization regardless of the correlation to febrile neutropenia and/or infection and adverse events will be reported and documented on teh AE form in teh respective CRF of teh participants.

  • Changes to efficacy parameters from baseline to 6 months [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

    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

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)

Estimated Enrollment: 700
Study Start Date: July 2011
Estimated Study Completion Date: July 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Detailed Description:

To observe the tolerability, safety and efficacy of preventative treatment using NivestimTM in patients receiving cytotoxic chemotherapy for cancer.

To investigate the description of the characteristics of patients being treated with NivestimTM, the treatment modalities using NivestimTM in the daily Routine, to investigate the description of the characteristics of the participating Physicians and to determine the general prescription practices of these physicians with regard to G-CSF.


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

Children and adult patients with a solid tumor or a malignant haematological tumor due to under go prophylatic treatment using Nivestim/


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 NivestimTM, either to shorten the duration of a neutropenia or to prevent the occurrence of chemotherapy induced 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 NivestimTM
  • Patients not undergoing chemotherapy
  • Patients being treated curatively with 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 identifier: NCT01627990

Contact: Rene Meissner ++49-89-43-7777-126

Facharzt für Innere Medizin, Onkologie, Hämatologie Recruiting
Ahaus, Germany, 48683
Principal Investigator: Hans Wilhelm Dubbers, MD         
"Facharzt für Innere Medizin Recruiting
Bad Sackingen, Germany, 79713
Principal Investigator: Philipp Hoffmeister, MD         
MediOnko-Institut GbR Recruiting
Berlin, Germany, 10367
Principal Investigator: Antje Wetzel, MD         
Sub-Investigator: Peter Klare, MD         
Sub-Investigator: Komelia Kittel, MD         
Onkoplan GmbH/Onkologische Schwerpunkpraxis Recruiting
Berlin, Germany, 13055
Principal Investigator: Manfred Kindler, PD, Dr.         
FA f. Frauenheilkunde und Geburtshilfe Gynakolgische Onkologie Recruiting
Chemnitz, Germany, 09117
Principal Investigator: Peter Jungberg, MD         
Gesellschaft für onkologische Studien Dortmund mbH Recruiting
Dortmund, Germany, 44263
Principal Investigator: Clemens Schulte, MD         
Gemeinschaftspraxis Recruiting
Dresden, Germany, 01307
Principal Investigator: Thomas Wolf, MD         
Sub-Investigator: Thomas Illmer, MD         
Gemeinschaftspraxis Haematologie/Medizin Onkologie Recruiting
Dusseldorf, Germany, 40479
Principal Investigator: Marie-Luise Plingen, MD         
Internist - Hämatologe - Onkologe Recruiting
Garbsen, Germany, 30827
Principal Investigator: Petros Panagiotou, MD         
Onkodok GmbH Recruiting
Gutersloh, Germany, 33332
Principal Investigator: Reinhard Depenbusch, MD         
Internist - Hämatologe - Onkologe Recruiting
Hannover, Germany, 30625
Principal Investigator: Detlev Schroder, MD         
ODZ-Petersen GmbH Recruiting
Heidenheim, Germany, 89518
Principal Investigator: Volker Petersen, MD         
DOKUSAN Gesellschaft für medizinische Studien mbH & Co. KG Recruiting
Herne, Germany, 44623
Principal Investigator: Lars Hahn, MD         
ZAGO Recruiting
Krefeld, Germany, 47805
Principal Investigator: Gunter Rogmans, MD         
Pneumologisch/onkologisch/internistisches Studienzentrum Recruiting
Leipzig, Germany, 04357
Principal Investigator: Christian Gessner, MD         
FA f. Frauenheilkunde und Geburtshilfe Recruiting
Lepzig, Germany, 04107
Principal Investigator: Nidal Gazawi, MD         
Fachübergreifende Gemeinschaftspraxis Innere Medizin, Hämatologie, Onkologie, Tumortherapie, Palliativmedizin Recruiting
Lippstadt, Germany, 59555
Principal Investigator: Kai Uwa Varnhorn         
Praxis für Innere Medizin, Hämatologie und Onkologie Recruiting
Mainz, Germany, 55131
Principal Investigator: Ina Wollner, MD         
Johannes Esling Klinikum Minden Recruiting
Minden, Germany, 32429
Principal Investigator: Martin Griesshammer, MD         
OnkoLog Moers GbR Recruiting
Moers, Germany, 47441
Principal Investigator: Jorg Wiegand, MD         
Fachärzte für Innere Medizin - Hämatologie u. Internistische Onkologie - Bluttransfusionswesen Recruiting
Munchen, Germany, 80638
Principal Investigator: Oliver Stolzer, Dr.         
Forschungs- und Studiengesellschaft HOPE München GmbH Recruiting
Munchen, Germany, 81245
Principal Investigator: Christiph Salat, Prof.,, Dr.         
Facharzt für Innere Medizin - Medikamentöse Tumortherapie - Palliativmedizin Recruiting
Neustadt/Sachsen, Germany, 01844
Principal Investigator: Jens Papke, MD         
MVZ Nordhausen gGmbH/ FA für Frauenheilkunde und Geburtshilfe Recruiting
Nordhausen, Germany, 99734
Principal Investigator: Andrea Grafe, MD         
Martha-Maria Krankenhaus gGmbH MVZ Onkologie Recruiting
Nurnberg, Germany, 90491
Principal Investigator: Astrid Rascu, MD         
Fachärztin für Innere Medizin Hämatologie u. Internistische Onkologie Recruiting
Oeide, Germany, 59302
Principal Investigator: Anja Hermening, MD         
Medizinisches Versorgungszentrum Onkologische Schwerpunktpraxis Recruiting
Olpe, Germany, 57462
Principal Investigator: Clemens Muller-Naendrup, MD         
Osnabruck, Germany, 49076
Principal Investigator: Stefan Fruhauf, MD         
Medizinisches Versorgungszentrum GbR Recruiting
Paradiese, Germany, 59494
Principal Investigator: Thomas Hamm, MD         
Facharzt für Innere Medizin - Hämatologie - Onkologie - Medikamentöse Tumortherapie Recruiting
Remscheid, Germany, 42859
Principal Investigator: Matthias Klee, MD         
Frauenärzte -Naturheilverfahren- Recruiting
Rodgau, Germany, 63110
Principal Investigator: Andre-R. Rotmann, MD         
Onkol. Managementgesellschaft Bonn/Rhein-Sieg/Ahr mbH Recruiting
Siegburg, Germany, 53721
Principal Investigator: Franz-Josef Heidgen, MD         
g.SUND Gyn. Kompetenzzentrum FA f. Frauenheilkunde & Geburtshilfe SP Gynäkologie Onkologie operative Gyn./ med. Tumortherapie/ Palliativmed. Recruiting
Stralsund, Germany, 18435
Principal Investigator: Carsten Hielscher, MD         
Fachärzte für Innere Medizin -Hämatologie und Internistische Onkologie Recruiting
Velbert, Germany, 42551
Principal Investigator: Arnd Nusch, MD         
FA f. Frauenheilkunde u. Geburtshilfe Marien-Hospital Witten gGmbH Recruiting
Witten, Germany, 58452
Principal Investigator: John Hackmann, MD         
Sub-Investigator: Felix Bartzsch, MD         
FA für innere Medizin/Hämatologie und Int. Onkologie/Palliativmedizin Recruiting
Zittau, Germany, 02763
Principal Investigator: Mathias Schulze, MD         
Sponsors and Collaborators
Hospira, Inc.
  More Information

No publications provided

Responsible Party: Hospira, Inc. Identifier: NCT01627990     History of Changes
Other Study ID Numbers: VENICE
Study First Received: June 7, 2012
Last Updated: July 7, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Hospira, Inc.:
cytotoxic chemotherapy
Solid tumor
Malignant hematological tumor

Additional relevant MeSH terms:
Hematologic Neoplasms
Hematologic Diseases
Neoplasms by Site processed this record on February 27, 2015