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Completed

NCT Number: NCT02178475

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

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.

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Key information

Conditions

Chemotherapy-Induced Febrile Neutropenia Agranulocytosis Breast Diseases Breast Neoplasms Cytopenia Febrile Neutropenia Hematologic Diseases Hemic and Lymphatic Diseases Leukocyte Disorders Leukopenia Neoplasms Neoplasms by Site Neutropenia Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Eggenburg, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

  1. Percentage of Participants With Febrile Neutropenia

    Time frame: Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.

    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.

Secondary outcomes

  1. Number of Participants Who Discontinued Pegfilgrastim Prophylaxis

    Time frame: Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.

    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).

  2. Number of Participants Who Discontinued G-CSF Prophylaxis

    Time frame: Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.

    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).

  3. Characteristics of Participants Who Discontinued Pegfilgrastim Prophylaxis

    Time frame: Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.

    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.

  4. Characteristics of Participants Who Discontinued G-CSF Prophylaxis

    Time frame: Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.

    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.

  5. Number of Cycles With No Pegfilgrastim Prophylaxis

    Time frame: Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.

    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.

  6. Number of Cycles With no G-CSF Prophylaxis

    Time frame: Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.

    A cycle of chemotherapy (cycle 2 or later) in which no G-CSF prophylaxis was administered.

  7. Reasons for Discontinuation of Pegfilgrastim Prophylaxis

    Time frame: Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.

    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.

  8. Reasons for Discontinuation of G-CSF Prophylaxis

    Time frame: Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.

    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.

  9. Percentage of Participants Who Experienced Complications of Febrile Neutropenia

    Time frame: Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.

    Complications of febrile neutropenia were defined as FN-related hospitalizations and death, and neutropenia-related chemotherapy dose delays and dose reductions.

  10. Number of Febrile Neutropenia Events That Occurred During Cycles With No G-CSF Prophylaxis

    Time frame: Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.

    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.

  11. Number of Participants Who Experienced Febrile Neutropenia During Cycles With No G-CSF Prophylaxis

    Time frame: Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.

    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.

  12. Number of Participants Who Experienced Complications of Febrile Neutropenia During Cycles With No G-CSF Prophylaxis

    Time frame: Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.

    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.

  13. Number of Cycles With No G-CSF Prophylaxis in Which Febrile Neutropenia Events Occurred

    Time frame: Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.

    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.

  14. Number of Cycles With No G-CSF Prophylaxis in Which Complications of Febrile Neutropenia Occurred

    Time frame: Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.

    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.

  15. Number of Participants Who Permanently Switched From Pegfilgrastim Prophylaxis to Other G-CSF Prophylaxis

    Time frame: Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.

    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.

  16. Characteristics of Participants Who Received On-schedule Pegfilgrastim Primary Prophylaxis

    Time frame: Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.

    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.

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jun 30, 2014
Registry last updated
Jul 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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