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

Hospira, now a wholly owned subsidiary of Pfizer2,114 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

2,114

Conditions

Solid Tumors Malignant Hemopathy Chemotherapy-induced Febrile Neutropenia (FN)

Interventions

Nivestim®BIOLOGICAL

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (87)

Outcomes

Primary Outcomes

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.

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.

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

Secondary Outcomes

Efficacy of treatment with Nivestim®

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)

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

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

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

Time frame: At Visit 1

Methods of treatment with Nivestim®

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

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

Profiles of the physicians participating in the study

Describe the profiles of the physicians participating in the study

Time frame: At visit 1

Data from ClinicalTrials.gov

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Hopital Louis Pasteur

Colmar, Alsace, France

Hopital Jean Monnet

Épinal, 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

MEDIPOLE

Aix-les-Bains, Auvergne-Rhône-Alpes, France

CHRA

Annecy, Auvergne-Rhône-Alpes, France

Clinique CONVERT

Bourg-en-Bresse, Auvergne-Rhône-Alpes, France

Ch Chambery

Chambéry, Auvergne-Rhône-Alpes, France

...and 77 more locations