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Trial record 1 of 1 for:    NCT01627990
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Nivestim™ in Treatment of Malignant Diseases

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ClinicalTrials.gov Identifier: NCT01627990
Recruitment Status : Completed
First Posted : June 26, 2012
Last Update Posted : July 24, 2015
Sponsor:
Information provided by (Responsible Party):
Hospira, now a wholly owned subsidiary of Pfizer

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.

Condition or disease
Solid Tumour Malignant Haematological Tumour Primary or Secondary Prophylactic Treatment

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).

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Study Type : Observational
Actual Enrollment : 386 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Compatibility of Nivestim™ Under Cytotoxic Chemotherapy in the Treatment of Malignant Diseases
Study Start Date : June 2011
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013



Primary Outcome Measures :
  1. Incidence of hospitalisation due to febrile neutropenia and/or infection [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Characterisation of patients being treated with Nivestim™ [ Time Frame: 6 months ]

    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™

  2. Treatment with Nivestim™ as part of daily routine [ Time Frame: 6 months ]
    • 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.

  3. Description of the efficacy of treatment with Nivestim™ [ Time Frame: 6 months ]

    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

  4. Detailed description of tolerability and safety [ Time Frame: 6 months ]
    • Hospitalisation
    • Adverse events

  5. Description of the characteristics of the participating physicians [ Time Frame: During the study initiation visit ]
    Socio-demographic data (age, gender, field of specialisation, structure of practice, title)

  6. Prescription routine of G-CSF (Granulocyte Colony-Stimulating Factor) [ Time Frame: During the study initiation visit ]
    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)


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01627990


Locations
Show Show 48 study locations
Sponsors and Collaborators
Hospira, now a wholly owned subsidiary of Pfizer
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Hospira, now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier: NCT01627990    
Other Study ID Numbers: VENICE
First Posted: June 26, 2012    Key Record Dates
Last Update Posted: July 24, 2015
Last Verified: July 2015
Keywords provided by Hospira, now a wholly owned subsidiary of Pfizer:
cytotoxic chemotherapy
G-CSF
Solid tumour
Malignant haematological tumour
Additional relevant MeSH terms:
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Neoplasms