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

NCT ID: NCT01574235

Last Updated: 2015-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2114 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-10-31

Study Completion Date

2014-02-28

Brief Summary

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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

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Curative or prophylactic Nivestim® treatment for FN

Nivestim®

Intervention Type BIOLOGICAL

Interventions

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Nivestim®

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospira, now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hopital Louis Pasteur

Colmar, Alsace, France

Site Status

Hopital Jean Monnet

Épinal, Alsace, France

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CH Emile Muller

Mulhouse, Alsace, France

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CAC Paul Strauss

Strasbourg, Alsace, France

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Chu Hopital Civil

Strasbourg, Alsace, France

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STE ANNE

Strasbourg, Alsace, France

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MEDIPOLE

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

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CHRA

Annecy, Auvergne-Rhône-Alpes, France

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Clinique CONVERT

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

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Ch Chambery

Chambéry, Auvergne-Rhône-Alpes, France

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Chu Grenoble

Grenoble, Auvergne-Rhône-Alpes, France

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Ch Valence

Valence, Auvergne-Rhône-Alpes, France

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Polyclinique Cesson

Cesson, Basse Normandie, France

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Chu Rennes

Rennes, Basse Normandie, France

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CHU SUD

Rennes, Basse Normandie, France

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Clinique St Laurent

Rennes, Basse Normandie, France

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Chp St Greg

Saint-Grégoire, Basse Normandie, France

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Ch St Malo

St-Malo, Basse Normandie, France

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CHG William MOREY

Chalon S/s, Bourgogne-Franche-Comté, France

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CHU du BOCAGE

Dijon, Bourgogne-Franche-Comté, France

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Clinique St Faron

Meaux, Champagne, France

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Cac Jean Godinot

Reims, Champagne, France

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Hopital St Quentin

Saint-Quentin, Champagne, France

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Hopital Troyes

Troyes, Champagne, France

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CHG Dieppe

Dieppe, Haute Normandie, France

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Clinique Pasteur

Évreux, Haute Normandie, France

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CH Jacques Monod

Montivilliers, Haute Normandie, France

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Centre frederic joliot curie

Rouen, Haute Normandie, France

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CHG

Alès, Languedoc, France

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CHG

Béziers, Languedoc, France

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CHG

Carcassonne, Languedoc, France

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Chu St Eloi

Montpellier, Languedoc, France

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Clinique Beausoleil

Montpellier, Languedoc, France

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CHU Caremeau

Nîmes, Languedoc, France

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Chg St Jean

Perpignan, Languedoc, France

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Ch Du Pays D'Aix

Aix-en-Provence, Marseille, France

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Clinique Rambot

Aix-en-Provence, Marseille, France

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Ch Duffaut

Avignon, Marseille, France

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Chp Clairval

Marseille, Marseille, France

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Chu Timone

Marseille, Marseille, France

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Fondation Saint Joseph

Marseille, Marseille, France

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Hopital A.Pare

Marseille, Marseille, France

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IPC

Marseille, Marseille, France

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Chr Brive

Brivé, Massif Central, France

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Chu Estaing

Clermont, Massif Central, France

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Chu Gabriel Montpied

Clermont, Massif Central, France

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Pole Sante Republique

Clermont, Massif Central, France

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Clinique Vitalia Desertines

Montluçon, Massif Central, France

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CHR

Roanne, Massif Central, France

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Icl St Etienne

Saint-Etienne, Massif Central, France

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CHG Cahors

Cahors, Midi Pyrennees, France

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CHG St Gaudens

Saint-Gaudens, Midi Pyrennees, France

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Clinique de l'Ormeau

Tarbes, Midi Pyrennees, France

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CHU Purpan

Toulouse, Midi Pyrennees, France

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Clinique Pasteur

Toulouse, Midi Pyrennees, France

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Inst. Claudius Regaud

Toulouse, Midi Pyrennees, France

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Clinique des Bonnettes

Arras, Nord, France

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CH Boulogne-sur-Mer

Boulogne, Nord, France

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Centre Oscar Lambret

Lille, Nord, France

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Clinique des Dentellieres

Valenciennes, Nord, France

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CH de Draguignan

Draguignan, Paca, France

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CHI de Fréjus

Fréjus, Paca, France

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Chi Frejus - St Raphael

Fréjus, Paca, France

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CHICAS

Gap, Paca, France

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Clinique Ste Marguerite

Hyères, Paca, France

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Clinique du Cap d'Or

La Seyne-sur-Mer, Paca, France

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Clinique Belvédère

Nice, Paca, France

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CH Sainte Musse

Toulon, Paca, France

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H.I.A Saint Anne

Toulon, Paca, France

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Victor Dubos

Argenteuil, Paris Nord, France

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Clinique Ste Marie

Osny, Paris Nord, France

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Saint Antoine

Paris, Paris Nord, France

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Saint Louis

Paris, Paris Nord, France

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TENON

Paris, Paris Nord, France

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Hpt Rene Dubos

Pontoise, Paris Nord, France

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Clinique Porte St Cloud

Boulogne, Paris Ouest, France

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BEAUJON

Clichy, Paris Ouest, France

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Hopital Mignot

Le Chesnay, Paris Ouest, France

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Hopital Franco Britannique

Levallois-Perret, Paris Ouest, France

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Hopital Des Courses

Maisons-Laffitte, Paris Ouest, France

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HARTMANN

Neuilly/seine, Paris Ouest, France

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Centre Rene Huguenin

Saint-Cloud, Paris Ouest, France

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Hopital Foch

Suresnes, Paris Ouest, France

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Ico Angers

Angers, Pays de la Loire Region, France

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Ch Cholet

Cholet, Pays de la Loire Region, France

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Ch Le Mans

Le Mans, Pays de la Loire Region, France

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Victor Hugo

Le Mans, Pays de la Loire Region, France

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Countries

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France

References

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Kamioner D, Fruehauf S, Maloisel F, Cals L, Lepretre S, Berthou C. Study design: two long-term observational studies of the biosimilar filgrastim Nivestim (Hospira filgrastim) in the treatment and prevention of chemotherapy-induced neutropenia. BMC Cancer. 2013 Nov 16;13:547. doi: 10.1186/1471-2407-13-547.

Reference Type DERIVED
PMID: 24237790 (View on PubMed)

Other Identifiers

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Identifier Type: -

Identifier Source: org_study_id

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