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

Completed

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

• 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

Arm && Interventions

Group	Intervention	Description
Curative or prophylactic Nivestim® treatment for FN	Nivestim®	-

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)

Polyclinique Cesson; 🇫🇷 Cesson, Basse Normandie, France

Hopital Troyes; 🇫🇷 Troyes, Champagne, France

CHG Dieppe; 🇫🇷 Dieppe, Haute Normandie, France

Centre frederic joliot curie; 🇫🇷 Rouen, Haute Normandie, France

CH Jacques Monod; 🇫🇷 Montivilliers, Haute Normandie, France

CHG St Gaudens; 🇫🇷 St Gaudens, Midi Pyrennees, France

Clinique des Dentellieres; 🇫🇷 Valenciennes, Nord, France

Clinique des Bonnettes; 🇫🇷 Arras, Nord, France

Inst. Claudius Regaud; 🇫🇷 Toulouse, Midi Pyrennees, France

Victor Dubos; 🇫🇷 Argenteuil, Paris Nord, France

Saint Antoine; 🇫🇷 Paris, Paris Nord, France

TENON; 🇫🇷 Paris, Paris Nord, France

BEAUJON; 🇫🇷 Clichy, Paris Ouest, France

Clinique Porte St Cloud; 🇫🇷 Boulogne, Paris Ouest, France

Hopital Foch; 🇫🇷 Suresnes, Paris Ouest, France

MEDIPOLE; 🇫🇷 Aix Les Bains, Rhone Alpes, France

CHRA; 🇫🇷 Annecy, Rhone Alpes, France

CH Emile Muller; 🇫🇷 Mulhouse, Alsace, France

STE ANNE; 🇫🇷 Strasbourg, Alsace, France

Hopital Louis Pasteur; 🇫🇷 Colmar, Alsace, France

Centre Oscar Lambret; 🇫🇷 Lille, Nord, France

Chu Hopital Civil; 🇫🇷 Strasbourg, Alsace, France

CHG; 🇫🇷 Carcassonne, Languedoc, France

Chu St Eloi; 🇫🇷 Montpellier, Languedoc, France

CHU Caremeau; 🇫🇷 Nimes, Languedoc, France

Chu Estaing; 🇫🇷 Clermont, Massif Central, France

Clinique Belvédère; 🇫🇷 Nice, Paca, France

Chu Grenoble; 🇫🇷 Grenoble, Rhone Alpes, France

Clinique Beausoleil; 🇫🇷 Montpellier, Languedoc, France

Clinique Vitalia Desertines; 🇫🇷 Montlucon, Massif Central, France

CHI de Fréjus; 🇫🇷 Frejus, Paca, France

CHU Purpan; 🇫🇷 Toulouse, Midi Pyrennees, France

Clinique Ste Marguerite; 🇫🇷 Hyeres, Paca, France

Hopital Des Courses; 🇫🇷 Maisons Laffitte, Paris Ouest, France

Hopital Franco Britannique; 🇫🇷 Levallois Perret, Paris Ouest, France

Ch Cholet; 🇫🇷 Cholet, Pays de La Loire, France

CHU SUD; 🇫🇷 Rennes, Basse Normandie, France

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

CHU du BOCAGE; 🇫🇷 Dijon, Bourgogne, France

Cac Jean Godinot; 🇫🇷 Reims, Champagne, France

Chu Rennes; 🇫🇷 Rennes, Basse Normandie, France

Hopital St Quentin; 🇫🇷 St Quentin, Champagne, France

Hopital Jean Monnet; 🇫🇷 Epinal, Alsace, France

Chp St Greg; 🇫🇷 St Gregoire, Basse Normandie, France

Clinique St Faron; 🇫🇷 Meaux, Champagne, France

CHG William MOREY; 🇫🇷 Chalon S/s, Bourgogne, France

Ch St Malo; 🇫🇷 St Malo, Basse Normandie, France

CAC Paul Strauss; 🇫🇷 Strasbourg, Alsace, France

Clinique Rambot; 🇫🇷 Aix En Provence, Marseille, France

Chg St Jean; 🇫🇷 Perpignan, Languedoc, France

CH Sainte Musse; 🇫🇷 Toulon, Paca, France

Clinique du Cap d'Or; 🇫🇷 La Seyne Sur Mer, Paca, France

Clinique Pasteur; 🇫🇷 Toulouse, Midi Pyrennees, France

CH de Draguignan; 🇫🇷 Draguignan, Paca, France

CHG Cahors; 🇫🇷 Cahors, Midi Pyrennees, France

Chr Brive; 🇫🇷 Brive, Massif Central, France

Hpt Rene Dubos; 🇫🇷 Pontoise, Paris Nord, France

Chi Frejus - St Raphael; 🇫🇷 Frejus, Paca, France

Clinique Ste Marie; 🇫🇷 Osny, Paris Nord, France

Ch Du Pays D'Aix; 🇫🇷 Aix En Provence, Marseille, France

CHICAS; 🇫🇷 GAP, Paca, France

CH Boulogne-sur-Mer; 🇫🇷 Boulogne, Nord, France

IPC; 🇫🇷 Marseille, France

Centre Rene Huguenin; 🇫🇷 St Cloud, Paris Ouest, France

Ch Duffaut; 🇫🇷 Avignon, Marseille, France

Chu Gabriel Montpied; 🇫🇷 Clermont, Massif Central, France

Saint Louis; 🇫🇷 Paris, Paris Nord, France

Icl St Etienne; 🇫🇷 St Etienne, Massif Central, France

CHR; 🇫🇷 Roanne, Massif Central, France

Clinique de l'Ormeau; 🇫🇷 Tarbes, Midi Pyrennees, France

Clinique CONVERT; 🇫🇷 Bourg en bresse, Rhone Alpes, France

Hopital Mignot; 🇫🇷 Le Chesnay, Paris Ouest, France

HARTMANN; 🇫🇷 Neuilly/seine, Paris Ouest, France

H.I.A Saint Anne; 🇫🇷 Toulon, Paca, France

Ch Chambery; 🇫🇷 Chambery, Rhone Alpes, France

Ch Le Mans; 🇫🇷 Le Mans, Pays de La Loire, France

Victor Hugo; 🇫🇷 Le Mans, Pays de La Loire, France

Ico Angers; 🇫🇷 Angers, Pays de La Loire, France

Chu Timone; 🇫🇷 Marseille, France

Chp Clairval; 🇫🇷 Marseille, France

Hopital A.Pare; 🇫🇷 Marseille, France

Fondation Saint Joseph; 🇫🇷 Marseille, France

Ch Valence; 🇫🇷 Valence, Rhone Alpes, France

Pole Sante Republique; 🇫🇷 Clermont, Massif Central, France