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

Chemotherapy-induced Febrile Neutropenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02178475
• Other study ID #: 20120214
• Status: Completed
• Start date: July 18, 2014
• Est. completion date: October 28, 2016

Study information

• Verified date: October 2017
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To estimate the incidence of febrile neutropenia in patients with breast cancer and non-Hodgkin's lymphoma receiving high (> 20%) FN-risk chemotherapy and pegfilgrastim primary prophylaxis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 943
• Est. completion date: October 28, 2016
• Est. primary completion date: October 28, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age = 18 years old.

• 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 involving Investigational Product that has not been approved by the national competent authorities for any indication.

• 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).

Related Conditions & MeSH terms

• Breast Neoplasms
• Chemotherapy-induced Febrile Neutropenia
• Febrile Neutropenia
• Fever
• Lymphoma, Non-Hodgkin
• Neutropenia

Locations

Country	Name	City	State
Austria	Research Site	Eggenburg
Austria	Research Site	Graz
Austria	Research Site	Leoben
Austria	Research Site	Schwarzach im Pongau
Austria	Research Site	Wien
Austria	Research Site	Wien
Belgium	Research Site	Arlon
Belgium	Research Site	Liege
Belgium	Research Site	Liège
Bulgaria	Research Site	Pleven
Bulgaria	Research Site	Sofia
Czechia	Research Site	Chomutov
Czechia	Research Site	Horovice
Czechia	Research Site	Novy Jicin
Czechia	Research Site	Plzen
Czechia	Research Site	Praha 10
Czechia	Research Site	Praha 2
France	Research Site	Aix en Provence
France	Research Site	Amiens
France	Research Site	Beuvry
France	Research Site	Marseille
France	Research Site	Marseille cedex 5
France	Research Site	Meaux Cedex
France	Research Site	Nancy
France	Research Site	Nimes cedex 09
France	Research Site	Orleans Cedex
France	Research Site	Périgueux cedex
France	Research Site	Perpignan
France	Research Site	Pierre Benite Cedex
France	Research Site	Saint Priest en Jarez Cedex
France	Research Site	Sarcelles
France	Research Site	Strasbourg
Germany	Research Site	Bonn
Germany	Research Site	Dresden
Germany	Research Site	Fulda
Germany	Research Site	Hildesheim
Germany	Research Site	Kassel
Germany	Research Site	Stolberg
Germany	Research Site	Troisdorf
Germany	Research Site	Velbert
Germany	Research Site	Westerstede
Greece	Research Site	Athens
Greece	Research Site	Athens
Greece	Research Site	Athens
Greece	Research Site	Chania
Greece	Research Site	Kalamata
Greece	Research Site	Larissa
Greece	Research Site	Nea Kifissia, Athens
Greece	Research Site	Papagou
Greece	Research Site	Piraeus
Greece	Research Site	Thessaloniki
Greece	Research Site	Thessaloniki
Greece	Research Site	Thessaloniki
Greece	Research Site	Thessaloniki
Poland	Research Site	Bialystok
Poland	Research Site	Gdynia
Poland	Research Site	Koszalin
Poland	Research Site	Krakow
Poland	Research Site	Krakow
Poland	Research Site	Poznan
Poland	Research Site	Walbrzych
Poland	Research Site	Warszawa
Poland	Research Site	Warszawa
Romania	Research Site	Baia Mare
Romania	Research Site	Braila
Romania	Research Site	Bucharest
Romania	Research Site	Bucharest
Romania	Research Site	Bucharest
Romania	Research Site	Bucuresti
Romania	Research Site	Bucuresti
Romania	Research Site	Campina
Romania	Research Site	Cluj-Napoca
Romania	Research Site	Iasi
Romania	Research Site	Oradea
Romania	Research Site	Ploiesti

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Countries where clinical trial is conducted

Austria,  Belgium,  Bulgaria,  Czechia,  France,  Germany,  Greece,  Poland,  Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Febrile Neutropenia	Febrile neutropenia (FN) was defined as an absolute neutrophil count (ANC) of < 0.5 x 10^9/L, or < 1.0 x 10^9/L predicted to fall below 0.5 x 10^9/L within 48 hours with fever or clinical signs of sepsis; fever and ANC were measured the same day or within ± 1 calendar day.	Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.
Secondary	Number of Participants Who Discontinued Pegfilgrastim Prophylaxis	Participants who discontinued pegfilgrastim prophylaxis was defined as participants who received at least one cycle of chemotherapy (cycle 2 or later) in which pegfilgrastim prophylaxis was not administered, but other granulocyte colony-stimulating factor (G-CSF) prophylaxis was administered. Participants in this group received either pegfilgrastim or other G-CSF prophylaxis in all chemotherapy cycles.; Discontinuation was categorized as either temporary (participant received pegfilgrastim prophylaxis in at least one subsequent cycle) or permanent (participant had at least one cycle of chemotherapy following the cycle in which no pegfilgrastim prophylaxis was administered, and other G-CSF prophylaxis (i.e. not pegfilgrastim) was administered in all subsequent cycles, OR participant did not receive pegfilgrastim prophylaxis in the last cycle of chemotherapy, and other G-CSF prophylaxis was administered).	Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.
Secondary	Number of Participants Who Discontinued G-CSF Prophylaxis	Participants who discontinued G-CSF prophylaxis was defined as participants who received at least one cycle of chemotherapy (cycle 2 or later) in which no G-CSF prophylaxis was administered.; Discontinuation was categorized as either temporary (participant received G-CSF prophylaxis in at least one subsequent cycle) or permanent (participant had at least one cycle of chemotherapy following the cycle in which no G-CSF prophylaxis was administered, and no G-CSF prophylaxis was administered in any subsequent cycle, OR participant did not receive G-CSF prophylaxis in the last cycle of chemotherapy).	Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.
Secondary	Characteristics of Participants Who Discontinued Pegfilgrastim Prophylaxis	Participants who discontinued pegfilgrastim prophylaxis are participants who received at least one cycle of chemotherapy (cycle 2 or later) in which pegfilgrastim prophylaxis was not administered, but other G-CSF prophylaxis was administered in this cycle. Participants in this group received either pegfilgrastim or other G-CSF prophylaxis in all chemotherapy cycles.; Data includes both temporary and permanent pegfilgrastim discontinuation.	Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.
Secondary	Characteristics of Participants Who Discontinued G-CSF Prophylaxis	Participants who discontinued G-CSF prophylaxis are participants who received at least one cycle of chemotherapy (cycle 2 or later) in which no G-CSF prophylaxis was administered.; Data includes both temporary and permanent discontinuation of G-CSF prophylaxis.	Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.
Secondary	Number of Cycles With No Pegfilgrastim Prophylaxis	A cycle of chemotherapy (cycle 2 or later) in which pegfilgrastim prophylaxis was not administered, but other G-CSF prophylaxis was administered in this cycle.	Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.
Secondary	Number of Cycles With no G-CSF Prophylaxis	A cycle of chemotherapy (cycle 2 or later) in which no G-CSF prophylaxis was administered.	Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.
Secondary	Reasons for Discontinuation of Pegfilgrastim Prophylaxis	Participants who discontinued pegfilgrastim prophylaxis are participants who received at least one cycle of chemotherapy (cycle 2 or later) in which pegfilgrastim prophylaxis was not administered, but other G-CSF prophylaxis was administered in this cycle. Participants in this group received either pegfilgrastim or other G-CSF prophylaxis in all chemotherapy cycles.; Data includes both temporary and permanent pegfilgrastim discontinuation.	Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.
Secondary	Reasons for Discontinuation of G-CSF Prophylaxis	Participants who discontinued G-CSF prophylaxis are participants who received at least one cycle of chemotherapy (cycle 2 or later) in which no G-CSF prophylaxis was administered.; Data includes both temporary and permanent discontinuation of G-CSF prophylaxis. Participants may have more than 1 discontinuation reason.	Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.
Secondary	Percentage of Participants Who Experienced Complications of Febrile Neutropenia	Complications of febrile neutropenia were defined as FN-related hospitalizations and death, and neutropenia-related chemotherapy dose delays and dose reductions.	Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.
Secondary	Number of Febrile Neutropenia Events That Occurred During Cycles With No G-CSF Prophylaxis	The number of febrile neutropenia events that occurred during a cycle of chemotherapy (cycle 2 or later) in which no G-CSF prophylaxis was administered. Febrile neutropenia was defined as an ANC of < 0.5 x 10^9/L, or < 1.0 x 10^9/L predicted to fall below 0.5 x 10^9/L within 48 hours with fever or clinical signs of sepsis; fever and ANC were measured the same day or within ± 1 calendar day.	Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.
Secondary	Number of Participants Who Experienced Febrile Neutropenia During Cycles With No G-CSF Prophylaxis	The number of participants who received at least one cycle of chemotherapy in which no G-CSF prophylaxis was administered who experienced febrile neutropenia during a cycle of chemotherapy in which no G-CSF prophylaxis was administered. Febrile neutropenia was defined as an ANC of < 0.5 x 10^9/L, or < 1.0 x 10^9/L predicted to fall below 0.5 x 10^9/L within 48 hours with fever or clinical signs of sepsis; fever and ANC were measured the same day or within ± 1 calendar day.	Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.
Secondary	Number of Participants Who Experienced Complications of Febrile Neutropenia During Cycles With No G-CSF Prophylaxis	The number of participants who received at least one cycle of chemotherapy in which no G-CSF prophylaxis was administered who experienced complications of febrile neutropenia during a cycle of chemotherapy in which no G-CSF prophylaxis was administered. Complications of febrile neutropenia were defined as FN-related hospitalizations and death, and neutropenia-related chemotherapy dose delays and dose reductions.	Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.
Secondary	Number of Cycles With No G-CSF Prophylaxis in Which Febrile Neutropenia Events Occurred	The number of chemotherapy cycles during which an event of febrile neutropenia occurred in which no G-CSF prophylaxis was administered. Febrile neutropenia was defined as an ANC of < 0.5 x 10^9/L, or < 1.0 x 10^9/L predicted to fall below 0.5 x 10^9/L within 48 hours with fever or clinical signs of sepsis; fever and ANC were measured the same day or within ± 1 calendar day.	Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.
Secondary	Number of Cycles With No G-CSF Prophylaxis in Which Complications of Febrile Neutropenia Occurred	The number of chemotherapy cycles during which complications of febrile neutropenia occurred in which no G-CSF prophylaxis was administered. Complications of febrile neutropenia were defined as FN-related hospitalizations and death, and neutropenia-related chemotherapy dose delays and dose reductions.	Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.
Secondary	Number of Participants Who Permanently Switched From Pegfilgrastim Prophylaxis to Other G-CSF Prophylaxis	The number of participants who received pegfilgrastim prophylaxis from cycle 1 until a cycle when other G-CSF prophylaxis was administered, and this G-CSF or a different G-CSF agent (not pegfilgrastim) was received as prophylaxis at each remaining cycle of the chemotherapy course.	Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.
Secondary	Characteristics of Participants Who Received On-schedule Pegfilgrastim Primary Prophylaxis	On-schedule pegfilgrastim primary prophylaxis was defined as participants who received pegfilgrastim in cycle 1 and continued to receive pegfilgrastim across all cycles, administered 1-3 days after the end of cytotoxic chemotherapy in each cycle.	Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.

External Links

•   AmgenTrials clinical trials website