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Completed

NCT Number: NCT01574235

Nivestim® (Filgrastim) Tolerance in Patients Treated by Toxic Chemotherapeutic Agents

The main aim of the study is to assess the safety of Nivestim® treatment in patients treated with neutropenia-inducing chemotherapy for a malignant disease, solid tumor or a malignant hemopathy.

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Key information

Conditions

Solid Tumors Agranulocytosis Chemotherapy-Induced Febrile Neutropenia Chemotherapy-induced Febrile Neutropenia (FN) Cytopenia Febrile Neutropenia Hematologic Diseases Hemic and Lymphatic Diseases Leukocyte Disorders Leukopenia Malignant Hemopathy Neutropenia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hopital Louis Pasteur, Colmar, Alsace, France

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age ≥ 18 years
  • Patients presenting with a solid tumor or a malignant hemopathy,
  • Patients treated with or beginning treatment with neutropenia-inducing chemotherapy (regardless of the cycle),
  • Patients in whom treatment with Nivestim® is instituted for the purpose of reducing the duration of the neutropenias and the incidence of the chemotherapy-induced febrile neutropenias

Exclusion criteria

  • Patients presenting with a chronic myeloproliferative syndrome,
  • Patients presenting with a myelodysplastic syndrome,
  • Patients showing hypersensitivity to any of the ingredients of Nivestim®,
  • Patients not receiving chemotherapy,
  • Patients who were already included in the study during a previous chemotherapy line

Treatment and study plan

Nivestim®

Biological

Primary outcomes

  1. Safety of Nivestim® to reduce or prevent febrile neutropenia in patients treated with neutropenia-inducing chemotherapy for a malignant disease, solid tumor or a malignant hemopathy.

    Time frame: Each patient will be followed for the duration of his chemotherapy regimen (the current one at the time of the Nivestim® treatment initiation) up to a maximum of six months

    The safety will be assessed by the record of all treatment emergent adverse events and all data about hospitalization due to any febrile neutropenia or infection.

Secondary outcomes

  1. Efficacy of treatment with Nivestim®

    Time frame: Each patient will be followed for the duration of his chemotherapy regimen (the current one at the time of the Nivestim® treatment initiation) up to a maximum of six months

    Assess the efficacy of the treatment with Nivestim® by studying occurrence of febrile neutropenia, infection and the impact of these events on the chemotherapy treatment (cycle postponement, dose reduction)

  2. Characteristics of the patients treated with Nivestim® in real-life practice

    Time frame: At Visit 1

    Describe the characteristics of the patients treated with Nivestim® in real-life practice,

  3. Methods of treatment with Nivestim®

    Time frame: Each patient will be followed for the duration of his chemotherapy regimen (the current one at the time of the Nivestim® treatment initiation) up to a maximum of six months

    Describe the methods of treatment with Nivestim® depending on the indications (curative or prophylactic) in routine practice.

  4. Profiles of the physicians participating in the study

    Time frame: At visit 1

    Describe the profiles of the physicians participating in the study

  5. General practice of these physicians with regard to prescription of Granulocyte-Colony Stimulating Factors (G-CSF)

    Time frame: At visit 1

    Assess the general practice of these physicians with regard to prescription of G-CSF

Sponsors and collaborators

Lead sponsor

Hospira, now a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study title

Safety of Nivestim® in Patients Treated With Neutropenia-inducing Anticancer Chemotherapy in Routine Practice

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Apr 10, 2012
Registry last updated
Jul 28, 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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