Nivestim(TM) 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: March 11, 2015
Last verified: March 2015
  Purpose

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).


Condition
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)

Enrollment: 386
Study Start Date: July 2011
Study Completion Date: December 2013
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.

  Eligibility

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/

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 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 ClinicalTrials.gov identifier: NCT01627990

Locations
Germany
Facharzt für Innere Medizin, Onkologie, Hämatologie
Ahaus, Germany, 48683
"Facharzt für Innere Medizin
Bad Sackingen, Germany, 79713
MediOnko-Institut GbR
Berlin, Germany, 10367
Onkoplan GmbH/Onkologische Schwerpunkpraxis
Berlin, Germany, 13055
FA f. Frauenheilkunde und Geburtshilfe Gynakolgische Onkologie
Chemnitz, Germany, 09117
Gesellschaft für onkologische Studien Dortmund mbH
Dortmund, Germany, 44263
Gemeinschaftspraxis
Dresden, Germany, 01307
Gemeinschaftspraxis Haematologie/Medizin Onkologie
Dusseldorf, Germany, 40479
Internist - Hämatologe - Onkologe
Garbsen, Germany, 30827
Onkodok GmbH
Gutersloh, Germany, 33332
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
Pneumologisch/onkologisch/internistisches Studienzentrum
Leipzig, Germany, 04357
FA f. Frauenheilkunde und Geburtshilfe
Lepzig, Germany, 04107
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
Munchen, Germany, 81245
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
Nurnberg, Germany, 90491
Fachärztin für Innere Medizin Hämatologie u. Internistische Onkologie
Oeide, Germany, 59302
Medizinisches Versorgungszentrum Onkologische Schwerpunktpraxis
Olpe, Germany, 57462
Osnabruck, Germany, 49076
Medizinisches Versorgungszentrum GbR
Paradiese, Germany, 59494
Facharzt für Innere Medizin - Hämatologie - Onkologie - Medikamentöse Tumortherapie
Remscheid, Germany, 42859
Frauenärzte -Naturheilverfahren-
Rodgau, Germany, 63110
Onkol. Managementgesellschaft Bonn/Rhein-Sieg/Ahr mbH
Siegburg, Germany, 53721
g.SUND Gyn. Kompetenzzentrum FA f. Frauenheilkunde & Geburtshilfe SP Gynäkologie Onkologie operative Gyn./ med. Tumortherapie/ Palliativmed.
Stralsund, Germany, 18435
Fachärzte für Innere Medizin -Hämatologie und Internistische Onkologie
Velbert, Germany, 42551
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: March 11, 2015
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

Additional relevant MeSH terms:
Hematologic Neoplasms
Hematologic Diseases
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on May 05, 2015