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Completed

NCT Number: NCT01627990

Nivestim™ in 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.

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Key information

Conditions

Solid Tumour Malignant Haematological Tumour Primary or Secondary Prophylactic Treatment

Sex eligibility

All sexes

Study type

Observational

Primary location

Facharzt für Innere Medizin, Onkologie, Hämatologie, Ahaus, Germany

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Incidence of hospitalisation due to febrile neutropenia and/or infection

    Time frame: 6 months

Secondary outcomes

  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™

Sponsors and collaborators

Lead sponsor

Hospira, now a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study title

The Compatibility of Nivestim™ Under Cytotoxic Chemotherapy in the Treatment of Malignant Diseases

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jun 26, 2012
Registry last updated
Jul 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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