Ignite Creation Date:
2025-12-24 @ 10:04 PM
Ignite Modification Date:
2025-12-27 @ 6:06 AM
Study NCT ID:
NCT01574235
Status:
COMPLETED
Last Update Posted:
2015-07-28
First Post:
2012-04-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nivestim® (Filgrastim) Tolerance in Patients Treated by Toxic Chemotherapeutic Agents
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D064146', 'term': 'Chemotherapy-Induced Febrile Neutropenia'}], 'ancestors': [{'id': 'D064147', 'term': 'Febrile Neutropenia'}, {'id': 'D009503', 'term': 'Neutropenia'}, {'id': 'D000380', 'term': 'Agranulocytosis'}, {'id': 'D007970', 'term': 'Leukopenia'}, {'id': 'D000095542', 'term': 'Cytopenia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007960', 'term': 'Leukocyte Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2114}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-27', 'studyFirstSubmitDate': '2012-04-04', 'studyFirstSubmitQcDate': '2012-04-09', 'lastUpdatePostDateStruct': {'date': '2015-07-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-04-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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', 'description': '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.'}], 'secondaryOutcomes': [{'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', 'description': '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)'}, {'measure': 'Characteristics of the patients treated with Nivestim® in real-life practice', 'timeFrame': 'At Visit 1', 'description': 'Describe the characteristics of the patients treated with Nivestim® in real-life practice,'}, {'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', 'description': 'Describe the methods of treatment with Nivestim® depending on the indications (curative or prophylactic) in routine practice.'}, {'measure': 'Profiles of the physicians participating in the study', 'timeFrame': 'At visit 1', 'description': 'Describe the profiles of the physicians participating in the study'}, {'measure': 'General practice of these physicians with regard to prescription of Granulocyte-Colony Stimulating Factors (G-CSF)', 'timeFrame': 'At visit 1', 'description': 'Assess the general practice of these physicians with regard to prescription of G-CSF'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Solid Tumors', 'Malignant Hemopathy', 'Chemotherapy-induced Febrile Neutropenia (FN)']}, 'referencesModule': {'references': [{'pmid': '24237790', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients receiving chemotherapy and treated with Nivestim® to prevent or reduce chemotherapy-induced febrile neutropenia.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years\n* Patients presenting with a solid tumor or a malignant hemopathy,\n* Patients treated with or beginning treatment with neutropenia-inducing chemotherapy (regardless of the cycle),\n* 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\n\nExclusion Criteria:\n\n* Patients presenting with a chronic myeloproliferative syndrome,\n* Patients presenting with a myelodysplastic syndrome,\n* Patients showing hypersensitivity to any of the ingredients of Nivestim®,\n* Patients not receiving chemotherapy,\n* Patients who were already included in the study during a previous chemotherapy line'}, 'identificationModule': {'nctId': 'NCT01574235', 'briefTitle': 'Nivestim® (Filgrastim) Tolerance in Patients Treated by Toxic Chemotherapeutic Agents', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hospira, now a wholly owned subsidiary of Pfizer'}, 'officialTitle': 'Safety of Nivestim® in Patients Treated With Neutropenia-inducing Anticancer Chemotherapy in Routine Practice', 'orgStudyIdInfo': {'id': 'NEXT'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Curative or prophylactic Nivestim® treatment for FN', 'interventionNames': ['Biological: Nivestim®']}], 'interventions': [{'name': 'Nivestim®', 'type': 'BIOLOGICAL', 'armGroupLabels': ['Curative or prophylactic Nivestim® treatment for FN']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Colmar', 'state': 'Alsace', 'country': 'France', 'facility': 'Hopital Louis Pasteur', 'geoPoint': {'lat': 48.08078, 'lon': 7.35584}}, {'city': 'Épinal', 'state': 'Alsace', 'country': 'France', 'facility': 'Hopital Jean Monnet', 'geoPoint': {'lat': 48.18324, 'lon': 6.45304}}, {'city': 'Mulhouse', 'state': 'Alsace', 'country': 'France', 'facility': 'CH Emile Muller', 'geoPoint': {'lat': 47.75205, 'lon': 7.32866}}, {'city': 'Strasbourg', 'state': 'Alsace', 'country': 'France', 'facility': 'CAC Paul Strauss', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'city': 'Strasbourg', 'state': 'Alsace', 'country': 'France', 'facility': 'Chu Hopital Civil', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'city': 'Strasbourg', 'state': 'Alsace', 'country': 'France', 'facility': 'STE ANNE', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'city': 'Aix-les-Bains', 'state': 'Auvergne-Rhône-Alpes', 'country': 'France', 'facility': 'MEDIPOLE', 'geoPoint': {'lat': 45.69173, 'lon': 5.90863}}, {'city': 'Annecy', 'state': 'Auvergne-Rhône-Alpes', 'country': 'France', 'facility': 'CHRA', 'geoPoint': {'lat': 45.90878, 'lon': 6.12565}}, {'city': 'Bourg-en-Bresse', 'state': 'Auvergne-Rhône-Alpes', 'country': 'France', 'facility': 'Clinique CONVERT', 'geoPoint': {'lat': 46.20574, 'lon': 5.2258}}, {'city': 'Chambéry', 'state': 'Auvergne-Rhône-Alpes', 'country': 'France', 'facility': 'Ch Chambery', 'geoPoint': {'lat': 45.56628, 'lon': 5.92079}}, {'city': 'Grenoble', 'state': 'Auvergne-Rhône-Alpes', 'country': 'France', 'facility': 'Chu Grenoble', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'city': 'Valence', 'state': 'Auvergne-Rhône-Alpes', 'country': 'France', 'facility': 'Ch Valence', 'geoPoint': {'lat': 44.9256, 'lon': 4.90956}}, {'city': 'Cesson', 'state': 'Basse Normandie', 'country': 'France', 'facility': 'Polyclinique Cesson', 'geoPoint': {'lat': 48.56204, 'lon': 2.60816}}, {'city': 'Rennes', 'state': 'Basse Normandie', 'country': 'France', 'facility': 'Chu Rennes', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'city': 'Rennes', 'state': 'Basse Normandie', 'country': 'France', 'facility': 'CHU SUD', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'city': 'Rennes', 'state': 'Basse Normandie', 'country': 'France', 'facility': 'Clinique St Laurent', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'city': 'Saint-Grégoire', 'state': 'Basse Normandie', 'country': 'France', 'facility': 'Chp St Greg', 'geoPoint': {'lat': 48.15101, 'lon': -1.68579}}, {'city': 'St-Malo', 'state': 'Basse Normandie', 'country': 'France', 'facility': 'Ch St Malo', 'geoPoint': {'lat': 48.64738, 'lon': -2.00877}}, {'city': 'Chalon S/s', 'state': 'Bourgogne-Franche-Comté', 'country': 'France', 'facility': 'CHG William MOREY'}, {'city': 'Dijon', 'state': 'Bourgogne-Franche-Comté', 'country': 'France', 'facility': 'CHU du BOCAGE', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'city': 'Meaux', 'state': 'Champagne', 'country': 'France', 'facility': 'Clinique St Faron', 'geoPoint': {'lat': 48.96014, 'lon': 2.87885}}, {'city': 'Reims', 'state': 'Champagne', 'country': 'France', 'facility': 'Cac Jean Godinot', 'geoPoint': {'lat': 49.26526, 'lon': 4.02853}}, {'city': 'Saint-Quentin', 'state': 'Champagne', 'country': 'France', 'facility': 'Hopital St Quentin', 'geoPoint': {'lat': 49.84889, 'lon': 3.28757}}, {'city': 'Troyes', 'state': 'Champagne', 'country': 'France', 'facility': 'Hopital Troyes', 'geoPoint': {'lat': 48.30073, 'lon': 4.08524}}, {'city': 'Dieppe', 'state': 'Haute Normandie', 'country': 'France', 'facility': 'CHG Dieppe', 'geoPoint': {'lat': 49.9216, 'lon': 1.07772}}, {'city': 'Évreux', 'state': 'Haute Normandie', 'country': 'France', 'facility': 'Clinique Pasteur', 'geoPoint': {'lat': 49.02414, 'lon': 1.15082}}, {'city': 'Montivilliers', 'state': 'Haute Normandie', 'country': 'France', 'facility': 'CH Jacques Monod', 'geoPoint': {'lat': 49.54518, 'lon': 0.18769}}, {'city': 'Rouen', 'state': 'Haute Normandie', 'country': 'France', 'facility': 'Centre frederic joliot curie', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'city': 'Alès', 'state': 'Languedoc', 'country': 'France', 'facility': 'CHG', 'geoPoint': {'lat': 44.12489, 'lon': 4.08082}}, {'city': 'Béziers', 'state': 'Languedoc', 'country': 'France', 'facility': 'CHG', 'geoPoint': {'lat': 43.34122, 'lon': 3.21402}}, {'city': 'Carcassonne', 'state': 'Languedoc', 'country': 'France', 'facility': 'CHG', 'geoPoint': {'lat': 43.21649, 'lon': 2.34863}}, {'city': 'Montpellier', 'state': 'Languedoc', 'country': 'France', 'facility': 'Chu St Eloi', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'city': 'Montpellier', 'state': 'Languedoc', 'country': 'France', 'facility': 'Clinique Beausoleil', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'city': 'Nîmes', 'state': 'Languedoc', 'country': 'France', 'facility': 'CHU Caremeau', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}, {'city': 'Perpignan', 'state': 'Languedoc', 'country': 'France', 'facility': 'Chg St Jean', 'geoPoint': {'lat': 42.69764, 'lon': 2.89541}}, {'city': 'Aix-en-Provence', 'state': 'Marseille', 'country': 'France', 'facility': "Ch Du Pays D'Aix", 'geoPoint': {'lat': 43.5283, 'lon': 5.44973}}, {'city': 'Aix-en-Provence', 'state': 'Marseille', 'country': 'France', 'facility': 'Clinique Rambot', 'geoPoint': {'lat': 43.5283, 'lon': 5.44973}}, {'city': 'Avignon', 'state': 'Marseille', 'country': 'France', 'facility': 'Ch Duffaut', 'geoPoint': {'lat': 43.94834, 'lon': 4.80892}}, {'city': 'Marseille', 'state': 'Marseille', 'country': 'France', 'facility': 'Chp Clairval', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'city': 'Marseille', 'state': 'Marseille', 'country': 'France', 'facility': 'Chu Timone', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'city': 'Marseille', 'state': 'Marseille', 'country': 'France', 'facility': 'Fondation Saint Joseph', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'city': 'Marseille', 'state': 'Marseille', 'country': 'France', 'facility': 'Hopital A.Pare', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'city': 'Marseille', 'state': 'Marseille', 'country': 'France', 'facility': 'IPC', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'city': 'Brivé', 'state': 'Massif Central', 'country': 'France', 'facility': 'Chr Brive', 'geoPoint': {'lat': 47.48857, 'lon': -2.00321}}, {'city': 'Clermont', 'state': 'Massif Central', 'country': 'France', 'facility': 'Chu Estaing', 'geoPoint': {'lat': 49.37897, 'lon': 2.41258}}, {'city': 'Clermont', 'state': 'Massif Central', 'country': 'France', 'facility': 'Chu Gabriel Montpied', 'geoPoint': {'lat': 49.37897, 'lon': 2.41258}}, {'city': 'Clermont', 'state': 'Massif Central', 'country': 'France', 'facility': 'Pole Sante Republique', 'geoPoint': {'lat': 49.37897, 'lon': 2.41258}}, {'city': 'Montluçon', 'state': 'Massif Central', 'country': 'France', 'facility': 'Clinique Vitalia Desertines', 'geoPoint': {'lat': 46.34015, 'lon': 2.60254}}, {'city': 'Roanne', 'state': 'Massif Central', 'country': 'France', 'facility': 'CHR', 'geoPoint': {'lat': 46.03624, 'lon': 4.06802}}, {'city': 'Saint-Etienne', 'state': 'Massif Central', 'country': 'France', 'facility': 'Icl St Etienne', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}, {'city': 'Cahors', 'state': 'Midi Pyrennees', 'country': 'France', 'facility': 'CHG Cahors', 'geoPoint': {'lat': 44.4491, 'lon': 1.43663}}, {'city': 'Saint-Gaudens', 'state': 'Midi Pyrennees', 'country': 'France', 'facility': 'CHG St Gaudens', 'geoPoint': {'lat': 43.10813, 'lon': 0.72318}}, {'city': 'Tarbes', 'state': 'Midi Pyrennees', 'country': 'France', 'facility': "Clinique de l'Ormeau", 'geoPoint': {'lat': 43.23407, 'lon': 0.07139}}, {'city': 'Toulouse', 'state': 'Midi Pyrennees', 'country': 'France', 'facility': 'CHU Purpan', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'city': 'Toulouse', 'state': 'Midi Pyrennees', 'country': 'France', 'facility': 'Clinique Pasteur', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'city': 'Toulouse', 'state': 'Midi Pyrennees', 'country': 'France', 'facility': 'Inst. Claudius Regaud', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'city': 'Arras', 'state': 'Nord', 'country': 'France', 'facility': 'Clinique des Bonnettes', 'geoPoint': {'lat': 50.29301, 'lon': 2.78186}}, {'city': 'Boulogne', 'state': 'Nord', 'country': 'France', 'facility': 'CH Boulogne-sur-Mer', 'geoPoint': {'lat': 46.79346, 'lon': -1.3194}}, {'city': 'Lille', 'state': 'Nord', 'country': 'France', 'facility': 'Centre Oscar Lambret', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'city': 'Valenciennes', 'state': 'Nord', 'country': 'France', 'facility': 'Clinique des Dentellieres', 'geoPoint': {'lat': 50.35909, 'lon': 3.52506}}, {'city': 'Draguignan', 'state': 'Paca', 'country': 'France', 'facility': 'CH de Draguignan', 'geoPoint': {'lat': 43.53692, 'lon': 6.46458}}, {'city': 'Fréjus', 'state': 'Paca', 'country': 'France', 'facility': 'CHI de Fréjus', 'geoPoint': {'lat': 43.43325, 'lon': 6.73555}}, {'city': 'Fréjus', 'state': 'Paca', 'country': 'France', 'facility': 'Chi Frejus - St Raphael', 'geoPoint': {'lat': 43.43325, 'lon': 6.73555}}, {'city': 'Gap', 'state': 'Paca', 'country': 'France', 'facility': 'CHICAS', 'geoPoint': {'lat': 44.55858, 'lon': 6.07868}}, {'city': 'Hyères', 'state': 'Paca', 'country': 'France', 'facility': 'Clinique Ste Marguerite', 'geoPoint': {'lat': 43.12038, 'lon': 6.12857}}, {'city': 'La Seyne-sur-Mer', 'state': 'Paca', 'country': 'France', 'facility': "Clinique du Cap d'Or", 'geoPoint': {'lat': 43.10322, 'lon': 5.87816}}, {'city': 'Nice', 'state': 'Paca', 'country': 'France', 'facility': 'Clinique Belvédère', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'city': 'Toulon', 'state': 'Paca', 'country': 'France', 'facility': 'CH Sainte Musse', 'geoPoint': {'lat': 43.12442, 'lon': 5.92836}}, {'city': 'Toulon', 'state': 'Paca', 'country': 'France', 'facility': 'H.I.A Saint Anne', 'geoPoint': {'lat': 43.12442, 'lon': 5.92836}}, {'city': 'Argenteuil', 'state': 'Paris Nord', 'country': 'France', 'facility': 'Victor Dubos', 'geoPoint': {'lat': 48.94788, 'lon': 2.24744}}, {'city': 'Osny', 'state': 'Paris Nord', 'country': 'France', 'facility': 'Clinique Ste Marie', 'geoPoint': {'lat': 49.0701, 'lon': 2.06277}}, {'city': 'Paris', 'state': 'Paris Nord', 'country': 'France', 'facility': 'Saint Antoine', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'state': 'Paris Nord', 'country': 'France', 'facility': 'Saint Louis', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'state': 'Paris Nord', 'country': 'France', 'facility': 'TENON', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Pontoise', 'state': 'Paris Nord', 'country': 'France', 'facility': 'Hpt Rene Dubos', 'geoPoint': {'lat': 49.05, 'lon': 2.1}}, {'city': 'Boulogne', 'state': 'Paris Ouest', 'country': 'France', 'facility': 'Clinique Porte St Cloud', 'geoPoint': {'lat': 46.79346, 'lon': -1.3194}}, {'city': 'Clichy', 'state': 'Paris Ouest', 'country': 'France', 'facility': 'BEAUJON', 'geoPoint': {'lat': 48.90018, 'lon': 2.30952}}, {'city': 'Le Chesnay', 'state': 'Paris Ouest', 'country': 'France', 'facility': 'Hopital Mignot', 'geoPoint': {'lat': 48.8222, 'lon': 2.12213}}, {'city': 'Levallois-Perret', 'state': 'Paris Ouest', 'country': 'France', 'facility': 'Hopital Franco Britannique', 'geoPoint': {'lat': 48.89389, 'lon': 2.28864}}, {'city': 'Maisons-Laffitte', 'state': 'Paris Ouest', 'country': 'France', 'facility': 'Hopital Des Courses', 'geoPoint': {'lat': 48.95264, 'lon': 2.14521}}, {'city': 'Neuilly/seine', 'state': 'Paris Ouest', 'country': 'France', 'facility': 'HARTMANN'}, {'city': 'Saint-Cloud', 'state': 'Paris Ouest', 'country': 'France', 'facility': 'Centre Rene Huguenin', 'geoPoint': {'lat': 48.84598, 'lon': 2.20289}}, {'city': 'Suresnes', 'state': 'Paris Ouest', 'country': 'France', 'facility': 'Hopital Foch', 'geoPoint': {'lat': 48.87143, 'lon': 2.22929}}, {'city': 'Angers', 'state': 'Pays de la Loire Region', 'country': 'France', 'facility': 'Ico Angers', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'city': 'Cholet', 'state': 'Pays de la Loire Region', 'country': 'France', 'facility': 'Ch Cholet', 'geoPoint': {'lat': 47.05893, 'lon': -0.87974}}, {'city': 'Le Mans', 'state': 'Pays de la Loire Region', 'country': 'France', 'facility': 'Ch Le Mans', 'geoPoint': {'lat': 48.0021, 'lon': 0.20251}}, {'city': 'Le Mans', 'state': 'Pays de la Loire Region', 'country': 'France', 'facility': 'Victor Hugo', 'geoPoint': {'lat': 48.0021, 'lon': 0.20251}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospira, now a wholly owned subsidiary of Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}