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

Completed

• Conditions: Malignant Hemopathy; Solid Tumors; Chemotherapy-induced Febrile Neutropenia (FN)

• Registration Number: NCT01574235
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2012-04-04
• Study First Submitted QC: 2012-04-09
• Study First Posted: 2012-04-10
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-27
• Last Update Posted: 2015-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2114

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	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

Name	Time	Method
Efficacy of treatment with Nivestim®	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)
Characteristics of the patients treated with Nivestim® in real-life practice	At Visit 1	Describe the characteristics of the patients treated with Nivestim® in real-life practice,
Methods of treatment with Nivestim®	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.
Profiles of the physicians participating in the study	At visit 1	Describe the profiles of the physicians participating in the study
General practice of these physicians with regard to prescription of Granulocyte-Colony Stimulating Factors (G-CSF)	At visit 1	Assess the general practice of these physicians with regard to prescription of G-CSF

Trial Locations

Locations (84)

Hopital Louis Pasteur; 🇫🇷 Colmar, Alsace, France

Hopital Jean Monnet; 🇫🇷 Epinal, Alsace, France

CH Emile Muller; 🇫🇷 Mulhouse, Alsace, France

CAC Paul Strauss; 🇫🇷 Strasbourg, Alsace, France

Chu Hopital Civil; 🇫🇷 Strasbourg, Alsace, France

STE ANNE; 🇫🇷 Strasbourg, Alsace, France

Polyclinique Cesson; 🇫🇷 Cesson, Basse Normandie, France

Chu Rennes; 🇫🇷 Rennes, Basse Normandie, France

CHU SUD; 🇫🇷 Rennes, Basse Normandie, France

Clinique St Laurent; 🇫🇷 Rennes, Basse Normandie, France

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