Overview

This trial has been completed.

Condition chemotherapy-induced febrile neutropenia
Sponsor Amgen
Start date July 2014
End date October 2016
Trial size 943 participants
Trial identifier NCT02178475, 20120214

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
Arm
Patients with Non-Hodgkin's Lymphoma who have initiated treatment with a permitted standard-dose chemotherapy regimen that has a high FN risk (> 20%) consistent with published studies or international guidelines, and who started pegfilgrastim in Cycle 1.
Patients with breast cancer who have initiated treatment with a permitted standard-dose chemotherapy regimen that has a high FN risk (> 20%) consistent with published studies or international guidelines, and who started pegfilgrastim in Cycle 1.

Primary Outcomes

Measure
To estimate the incidence of FN in all subjects
time frame: Participants will be followed up for a maximum of 8 cycles of chemotherapy, an average observation period would be around 18 weeks.

Secondary Outcomes

Measure
To describe discontinuation of pegfilgrastim prophylaxis and discontinuation of G-CSF prophylaxis in terms of reasons and frequency of subjects and cycles
time frame: Participants will be followed up for a maximum of 8 cycles of chemotherapy, an average observation period would be around 18 weeks.
To estimate the incidence of complications of FN in all subjects across all cycles
time frame: Participants will be followed up for a maximum of 8 cycles of chemotherapy, an average observation period would be around 18 weeks.
To estimate the incidence of FN and complications of FN in discontinuation of G-CSF prophylaxis cycles at the subject and cycle level
time frame: Participants will be followed up for a maximum of 8 cycles of chemotherapy, an average observation period would be around 18 weeks.
To estimate the frequency of switch from pegfilgrastim prophylaxis to other G-CSF(s)
time frame: Participants will be followed up for a maximum of 8 cycles of chemotherapy, an average observation period would be around 18 weeks.

Eligibility Criteria

Male or female participants at least 18 years old.

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 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).

Additional Information

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
Description A prospective study design will enable collection of reasons from physicians as to why they chose to discontinue pegfilagrastim PP before the end of the chemotherapy course. Additionally, it will facilitate data collection of sufficient quality and magnitude to reliably estimate neutropenic outcomes, pegfilgrastim discontinuation rates, and subject characteristics in those who discontinued.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Amgen.