Nivestim® (Filgrastim) Tolerance in Patients Treated by Toxic Chemotherapeutic Agents
Safety of Nivestim® in Patients Treated With Neutropenia-inducing Anticancer Chemotherapy in Routine Practice
1 other identifier
observational
2,114
1 country
87
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2011
Typical duration for all trials
87 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2011
CompletedFirst Submitted
Initial submission to the registry
April 4, 2012
CompletedFirst Posted
Study publicly available on registry
April 10, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2014
CompletedJuly 28, 2015
July 1, 2015
2.3 years
April 4, 2012
July 27, 2015
Conditions
Outcome Measures
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.
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.
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 (5)
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
Characteristics of the patients treated with Nivestim® in real-life practice
At Visit 1
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
Profiles of the physicians participating in the study
At visit 1
General practice of these physicians with regard to prescription of Granulocyte-Colony Stimulating Factors (G-CSF)
At visit 1
Study Arms (1)
Curative or prophylactic Nivestim® treatment for FN
Interventions
Eligibility Criteria
Patients receiving chemotherapy and treated with Nivestim® to prevent or reduce chemotherapy-induced febrile neutropenia.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (87)
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
Chu Grenoble
Grenoble, Auvergne-Rhône-Alpes, France
Ch Valence
Valence, Auvergne-Rhône-Alpes, 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
Chp St Greg
Saint-Grégoire, Basse Normandie, France
Ch St Malo
St-Malo, Basse Normandie, France
CHG William MOREY
Chalon S/s, Bourgogne-Franche-Comté, France
CHU du BOCAGE
Dijon, Bourgogne-Franche-Comté, France
Clinique St Faron
Meaux, Champagne, France
Cac Jean Godinot
Reims, Champagne, France
Hopital St Quentin
Saint-Quentin, Champagne, France
Hopital Troyes
Troyes, Champagne, France
CHG Dieppe
Dieppe, Haute Normandie, France
Clinique Pasteur
Évreux, Haute Normandie, France
CH Jacques Monod
Montivilliers, Haute Normandie, France
Centre frederic joliot curie
Rouen, Haute Normandie, France
CHG
Alès, Languedoc, France
CHG
Béziers, Languedoc, France
CHG
Carcassonne, Languedoc, France
Chu St Eloi
Montpellier, Languedoc, France
Clinique Beausoleil
Montpellier, Languedoc, France
CHU Caremeau
Nîmes, Languedoc, France
Chg St Jean
Perpignan, Languedoc, France
Ch Du Pays D'Aix
Aix-en-Provence, Marseille, France
Clinique Rambot
Aix-en-Provence, Marseille, France
Ch Duffaut
Avignon, Marseille, France
Chp Clairval
Marseille, Marseille, France
Chu Timone
Marseille, Marseille, France
Fondation Saint Joseph
Marseille, Marseille, France
Hopital A.Pare
Marseille, Marseille, France
IPC
Marseille, Marseille, France
Chr Brive
Brivé, Massif Central, France
Chu Estaing
Clermont, Massif Central, France
Chu Gabriel Montpied
Clermont, Massif Central, France
Pole Sante Republique
Clermont, Massif Central, France
Clinique Vitalia Desertines
Montluçon, Massif Central, France
CHR
Roanne, Massif Central, France
Icl St Etienne
Saint-Etienne, Massif Central, France
CHG Cahors
Cahors, Midi Pyrennees, France
CHG St Gaudens
Saint-Gaudens, Midi Pyrennees, France
Clinique de l'Ormeau
Tarbes, Midi Pyrennees, France
CHU Purpan
Toulouse, Midi Pyrennees, France
Clinique Pasteur
Toulouse, Midi Pyrennees, France
Inst. Claudius Regaud
Toulouse, Midi Pyrennees, France
Clinique des Bonnettes
Arras, Nord, France
CH Boulogne-sur-Mer
Boulogne, Nord, France
Centre Oscar Lambret
Lille, Nord, France
Clinique des Dentellieres
Valenciennes, Nord, France
CH de Draguignan
Draguignan, Paca, France
CHI de Fréjus
Fréjus, Paca, France
Chi Frejus - St Raphael
Fréjus, Paca, France
CHICAS
Gap, Paca, France
Clinique Ste Marguerite
Hyères, Paca, France
Clinique du Cap d'Or
La Seyne-sur-Mer, Paca, France
Clinique Belvédère
Nice, Paca, France
CH Sainte Musse
Toulon, Paca, France
H.I.A Saint Anne
Toulon, Paca, France
Victor Dubos
Argenteuil, Paris Nord, France
Clinique Ste Marie
Osny, Paris Nord, France
Saint Antoine
Paris, Paris Nord, France
Saint Louis
Paris, Paris Nord, France
TENON
Paris, Paris Nord, France
Hpt Rene Dubos
Pontoise, Paris Nord, France
Clinique Porte St Cloud
Boulogne, Paris Ouest, France
BEAUJON
Clichy, Paris Ouest, France
Hopital Mignot
Le Chesnay, Paris Ouest, France
Hopital Franco Britannique
Levallois-Perret, Paris Ouest, France
Hopital Des Courses
Maisons-Laffitte, Paris Ouest, France
HARTMANN
Neuilly/seine, Paris Ouest, France
Centre Rene Huguenin
Saint-Cloud, Paris Ouest, France
Hopital Foch
Suresnes, Paris Ouest, France
Ico Angers
Angers, Pays de la Loire Region, France
Ch Cholet
Cholet, Pays de la Loire Region, France
Ch Le Mans
Le Mans, Pays de la Loire Region, France
Victor Hugo
Le Mans, Pays de la Loire Region, France
Related Publications (1)
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.
PMID: 24237790DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 4, 2012
First Posted
April 10, 2012
Study Start
October 1, 2011
Primary Completion
February 1, 2014
Study Completion
February 1, 2014
Last Updated
July 28, 2015
Record last verified: 2015-07