Clinical trial NCT01574235: Nivestim® (Filgrastim) Tolerance in Patients Treated by Toxic Chemotherapeutic Agents
Official title: Safety of Nivestim® in Patients Treated With Neutropenia-inducing Anticancer Chemotherapy in Routine Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Solid Tumors
Malignant Hemopathy
Chemotherapy-induced Febrile Neutropenia (FN)
Lead sponsor: Hospira, now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2012-04-10
Enrollment: 2114
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients receiving chemotherapy and treated with Nivestim® to prevent or reduce chemotherapy-induced febrile neutropenia.

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.


Eligibility 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

Primary outcomes:
measure: 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.
timeFrame: 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:
measure: Efficacy of treatment with Nivestim®
timeFrame: 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
measure: Characteristics of the patients treated with Nivestim® in real-life practice
timeFrame: At Visit 1
measure: Methods of treatment with Nivestim®
timeFrame: 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
measure: Profiles of the physicians participating in the study
timeFrame: At visit 1
measure: General practice of these physicians with regard to prescription of Granulocyte-Colony Stimulating Factors (G-CSF)
timeFrame: At visit 1
Other outcomes:
Locations:
city: Colmar
country: France
facility: Hopital Louis Pasteur
state: Alsace
city: Epinal
country: France
facility: Hopital Jean Monnet
state: Alsace
city: Mulhouse
country: France
facility: CH Emile Muller
state: Alsace
city: Strasbourg
country: France
facility: CAC Paul Strauss
state: Alsace
city: Strasbourg
country: France
facility: Chu Hopital Civil
state: Alsace
city: Strasbourg
country: France
facility: STE ANNE
state: Alsace
city: Cesson
country: France
facility: Polyclinique Cesson
state: Basse Normandie
city: Rennes
country: France
facility: Chu Rennes
state: Basse Normandie
city: Rennes
country: France
facility: CHU SUD
state: Basse Normandie
city: Rennes
country: France
facility: Clinique St Laurent
state: Basse Normandie
city: St Gregoire
country: France
facility: Chp St Greg
state: Basse Normandie
city: St Malo
country: France
facility: Ch St Malo
state: Basse Normandie
city: Chalon S/s
country: France
facility: CHG William MOREY
state: Bourgogne
city: Dijon
country: France
facility: CHU du BOCAGE
state: Bourgogne
city: Meaux
country: France
facility: Clinique St Faron
state: Champagne
city: Reims
country: France
facility: Cac Jean Godinot
state: Champagne
city: St Quentin
country: France
facility: Hopital St Quentin
state: Champagne
city: Troyes
country: France
facility: Hopital Troyes
state: Champagne
city: Dieppe
country: France
facility: CHG Dieppe
state: Haute Normandie
city: Evreux
country: France
facility: Clinique Pasteur
state: Haute Normandie
city: Montivilliers
country: France
facility: CH Jacques Monod
state: Haute Normandie
city: Rouen
country: France
facility: Centre frederic joliot curie
state: Haute Normandie
city: Ales
country: France
facility: CHG
state: Languedoc
city: Beziers
country: France
facility: CHG
state: Languedoc
city: Carcassonne
country: France
facility: CHG
state: Languedoc
city: Montpellier
country: France
facility: Chu St Eloi
state: Languedoc
city: Montpellier
country: France
facility: Clinique Beausoleil
state: Languedoc
city: Nimes
country: France
facility: CHU Caremeau
state: Languedoc
city: Perpignan
country: France
facility: Chg St Jean
state: Languedoc
city: Aix En Provence
country: France
facility: Ch Du Pays D'Aix
state: Marseille
city: Aix En Provence
country: France
facility: Clinique Rambot
state: Marseille
city: Avignon
country: France
facility: Ch Duffaut
state: Marseille
city: Brive
country: France
facility: Chr Brive
state: Massif Central
city: Clermont
country: France
facility: Chu Estaing
state: Massif Central
city: Clermont
country: France
facility: Chu Gabriel Montpied
state: Massif Central
city: Clermont
country: France
facility: Pole Sante Republique
state: Massif Central
city: Montlucon
country: France
facility: Clinique Vitalia Desertines
state: Massif Central
city: Roanne
country: France
facility: CHR
state: Massif Central
city: St Etienne
country: France
facility: Icl St Etienne
state: Massif Central
city: Cahors
country: France
facility: CHG Cahors
state: Midi Pyrennees
city: St Gaudens
country: France
facility: CHG St Gaudens
state: Midi Pyrennees
city: Tarbes
country: France
facility: Clinique de l'Ormeau
state: Midi Pyrennees
city: Toulouse
country: France
facility: CHU Purpan
state: Midi Pyrennees
city: Toulouse
country: France
facility: Clinique Pasteur
state: Midi Pyrennees
city: Toulouse
country: France
facility: Inst. Claudius Regaud
state: Midi Pyrennees
city: Arras
country: France
facility: Clinique des Bonnettes
state: Nord
city: Boulogne
country: France
facility: CH Boulogne-sur-Mer
state: Nord
city: Lille
country: France
facility: Centre Oscar Lambret
state: Nord
city: Valenciennes
country: France
facility: Clinique des Dentellieres
state: Nord
city: Draguignan
country: France
facility: CH de Draguignan
state: Paca
city: Frejus
country: France
facility: CHI de Fréjus
state: Paca
city: Frejus
country: France
facility: Chi Frejus - St Raphael
state: Paca
city: GAP
country: France
facility: CHICAS
state: Paca
city: Hyeres
country: France
facility: Clinique Ste Marguerite
state: Paca
city: La Seyne Sur Mer
country: France
facility: Clinique du Cap d'Or
state: Paca
city: Nice
country: France
facility: Clinique Belvédère
state: Paca
city: Toulon
country: France
facility: CH Sainte Musse
state: Paca
city: Toulon
country: France
facility: H.I.A Saint Anne
state: Paca
city: Argenteuil
country: France
facility: Victor Dubos
state: Paris Nord
city: Osny
country: France
facility: Clinique Ste Marie
state: Paris Nord
city: Paris
country: France
facility: Saint Antoine
state: Paris Nord
city: Paris
country: France
facility: Saint Louis
state: Paris Nord
city: Paris
country: France
facility: TENON
state: Paris Nord
city: Pontoise
country: France
facility: Hpt Rene Dubos
state: Paris Nord
city: Boulogne
country: France
facility: Clinique Porte St Cloud
state: Paris Ouest
city: Clichy
country: France
facility: BEAUJON
state: Paris Ouest
city: Le Chesnay
country: France
facility: Hopital Mignot
state: Paris Ouest
city: Levallois Perret
country: France
facility: Hopital Franco Britannique
state: Paris Ouest
city: Maisons Laffitte
country: France
facility: Hopital Des Courses
state: Paris Ouest
city: Neuilly/seine
country: France
facility: HARTMANN
state: Paris Ouest
city: St Cloud
country: France
facility: Centre Rene Huguenin
state: Paris Ouest
city: Suresnes
country: France
facility: Hopital Foch
state: Paris Ouest
city: Angers
country: France
facility: Ico Angers
state: Pays de La Loire
city: Cholet
country: France
facility: Ch Cholet
state: Pays de La Loire
city: Le Mans
country: France
facility: Ch Le Mans
state: Pays de La Loire
city: Le Mans
country: France
facility: Victor Hugo
state: Pays de La Loire
city: Aix Les Bains
country: France
facility: MEDIPOLE
state: Rhone Alpes
city: Annecy
country: France
facility: CHRA
state: Rhone Alpes
city: Bourg en bresse
country: France
facility: Clinique CONVERT
state: Rhone Alpes
city: Chambery
country: France
facility: Ch Chambery
state: Rhone Alpes
city: Grenoble
country: France
facility: Chu Grenoble
state: Rhone Alpes
city: Valence
country: France
facility: Ch Valence
state: Rhone Alpes
city: Marseille
country: France
facility: Chp Clairval
city: Marseille
country: France
facility: Chu Timone
city: Marseille
country: France
facility: Fondation Saint Joseph
city: Marseille
country: France
facility: Hopital A.Pare
city: Marseille
country: France
facility: IPC
Study officials:
References:
citation: 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.