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

June 7, 2012
July 23, 2015
June 2011
December 2013   (final data collection date for primary outcome measure)
Incidence of hospitalisation due to febrile neutropenia and/or infection [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
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.
Complete list of historical versions of study NCT01627990 on ClinicalTrials.gov Archive Site
  • 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™
  • 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
Not Provided
Not Provided
 
Nivestim™ in Treatment of Malignant Diseases
The Compatibility of Nivestim™ Under Cytotoxic Chemotherapy in the Treatment of Malignant Diseases
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.
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).
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:
  • 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)
Non-Probability Sample
Children and adult patients with a solid tumour or a malignant haematological tumour
  • Solid Tumour
  • Malignant Haematological Tumour
  • Primary or Secondary Prophylactic Treatment
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
386
December 2013
December 2013   (final data collection date for primary outcome measure)

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)
Both
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01627990
VENICE
No
Not Provided
Not Provided
Hospira, Inc.
Hospira, Inc.
Not Provided
Not Provided
Hospira, Inc.
July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP