Prospective Observational Study of Febrile Neutropenia (FN) and Pegfilgrastim Primary Prophylaxis in Breast Cancer and Non-Hodgkin's Lymphoma Patients Receiving High (>20%) FN-risk Chemotherapy
NCT ID: NCT02178475
Last Updated: 2018-07-23
Study Results
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View full resultsBasic Information
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COMPLETED
943 participants
OBSERVATIONAL
2014-07-18
2016-10-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Chemotherapy + Pegfilgrastim
Patients with non-Hodgkin's lymphoma or breast cancer being treated with a permitted standard-dose chemotherapy regimen with a high FN risk (\> 20%) and who had pegfilgrastim prophylaxis initiated in the first cycle of chemotherapy.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Any stage NHL or breast cancer and received the first cycle of a new chemotherapy course.
* Received the first cycle of a permitted standard dose chemotherapy regimens with an estimated high (\> 20%) FN risk according to published data or guidelines (dose modifications +/-10% in Cycle 1 are allowable).
* Initiated treatment in Cycle 1 with pegfilgrastim according to the pegfilgrastim summary of product characteristics. (SmPC). Enrolment must occur after the first pegfilgrastim dosing in Cycle 1 and before the second day of Cycle 2.
Exclusion Criteria
* Ongoing or planned concurrent participation in any clinical study where the administration of Colony Stimulating Factor (CSF) is determined by the protocol (clinical trials on an approved drug and observational trials are permitted as long as these do not mandate how neutropenia should be treated).
18 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Research Site
Eggenburg, , Austria
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Graz, , Austria
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Leoben, , Austria
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Schwarzach im Pongau, , Austria
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Vienna, , Austria
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Vienna, , Austria
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Arlon, , Belgium
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Liège, , Belgium
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Pleven, , Bulgaria
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Sofia, , Bulgaria
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Chomutov, , Czechia
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Hořovice, , Czechia
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Nový Jičín, , Czechia
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Pilsen, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Aix-en-Provence, , France
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Amiens, , France
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Beuvry, , France
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Marseille, , France
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Marseille, , France
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Meaux, , France
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Nancy, , France
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Nîmes, , France
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Orléans, , France
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Perpignan, , France
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Périgueux, , France
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Pierre-Bénite, , France
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Saint-Priest-en-Jarez, , France
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Sarcelles, , France
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Strasbourg, , France
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Bonn, , Germany
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Dresden, , Germany
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Fulda, , Germany
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Hildesheim, , Germany
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Kassel, , Germany
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Stolberg, , Germany
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Troisdorf, , Germany
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Velbert, , Germany
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Westerstede, , Germany
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Athens, , Greece
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Athens, , Greece
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Athens, , Greece
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Chania, , Greece
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Kalamata, , Greece
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Larissa, , Greece
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Nea Kifissia, Athens, , Greece
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Papagou, , Greece
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Piraeus, , Greece
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Thessaloniki, , Greece
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Thessaloniki, , Greece
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Thessaloniki, , Greece
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Thessaloniki, , Greece
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Bialystok, , Poland
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Gdynia, , Poland
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Koszalin, , Poland
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Krakow, , Poland
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Krakow, , Poland
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Poznan, , Poland
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Warsaw, , Poland
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Warsaw, , Poland
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Wałbrzych, , Poland
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Baia Mare, , Romania
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Brăila, , Romania
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Bucharest, , Romania
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Bucharest, , Romania
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Bucharest, , Romania
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Bucharest, , Romania
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Bucharest, , Romania
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Câmpina, , Romania
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Cluj-Napoca, , Romania
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Iași, , Romania
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Oradea, , Romania
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Ploieşti, , Romania
Countries
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References
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Mahtani RL, Belani R, Crawford J, Dale D, DeCosta L, Gawade PL, Huynh C, Lawrence T, Lewis S, MacLaughlin WW, Narang M, Rifkin R. A prospective cohort study to evaluate the incidence of febrile neutropenia in patients receiving pegfilgrastim on-body injector versus other options for prophylaxis of febrile neutropenia: breast cancer subgroup analysis. Support Care Cancer. 2022 Jul;30(7):6135-6144. doi: 10.1007/s00520-022-07025-2. Epub 2022 Apr 14.
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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20120214
Identifier Type: -
Identifier Source: org_study_id
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