COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01574235
Recruitment Status : Completed
First Posted : April 10, 2012
Last Update Posted : July 28, 2015
Sponsor:
Information provided by (Responsible Party):
Hospira, now a wholly owned subsidiary of Pfizer

Brief Summary:
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.

Condition or disease Intervention/treatment
Solid Tumors Malignant Hemopathy Chemotherapy-induced Febrile Neutropenia (FN) Biological: Nivestim®

Layout table for study information
Study Type : Observational
Actual Enrollment : 2114 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Safety of Nivestim® in Patients Treated With Neutropenia-inducing Anticancer Chemotherapy in Routine Practice
Study Start Date : October 2011
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Curative or prophylactic Nivestim® treatment for FN Biological: Nivestim®



Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients receiving chemotherapy and treated with Nivestim® to prevent or reduce chemotherapy-induced febrile neutropenia.
Criteria

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

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): NCT01574235


Locations
Show Show 87 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):
Layout table for additonal information
Responsible Party: Hospira, now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier: NCT01574235    
Other Study ID Numbers: NEXT
First Posted: April 10, 2012    Key Record Dates
Last Update Posted: July 28, 2015
Last Verified: July 2015
Additional relevant MeSH terms:
Layout table for MeSH terms
Neutropenia
Febrile Neutropenia
Chemotherapy-Induced Febrile Neutropenia
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases