Clinical Trial: 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

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

Brief 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

Detailed Summary: 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.
Sponsor: Amgen

Current Primary Outcome: 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. ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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. ]
    Proportion of subjects who experience complications of FN
  • 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. ]
    Proportion of FN events occuring in discontinuation of G-CSF prophylaxis cycles; proportion of discontinuation of G-CSF prophylaxis subjects who experience FN in discontinuation of G-CSF prophylaxis cycles; proportion of discontinuation of G-CSF prophylaxis subjects who experience complications of FN in discontinuation of G-CSF prophylaxis cycles; proportion of discontinuation of G-CSF prophylaxis cycles with FN; proportion of discontinuation of G-CSF prophylaxis with complications of FN
  • 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. ]


Original Secondary Outcome: Same as current

Information By: Amgen

Dates:
Date Received: June 10, 2014
Date Started: July 2014
Date Completion:
Last Updated: November 17, 2016
Last Verified: November 2016