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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

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ClinicalTrials.gov Identifier: NCT02178475
Recruitment Status : Completed
First Posted : June 30, 2014
Results First Posted : July 23, 2018
Last Update Posted : July 23, 2018
Sponsor:
Information provided by (Responsible Party):
Amgen

Brief 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.

Condition or disease
Chemotherapy-induced Febrile Neutropenia

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Study Type : Observational
Actual Enrollment : 943 participants
Observational Model: Case-Only
Time Perspective: Prospective
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
Actual Study Start Date : July 18, 2014
Actual Primary Completion Date : October 28, 2016
Actual Study Completion Date : October 28, 2016


Group/Cohort
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.



Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with NHL or breast cancer who have initiated treatment with a permitted standard-dose chemotherapy regimen that has a high FN risk (> 20%) per published studies or international guidelines, and who started pegfilgrastim in Cycle 1
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02178475


Locations
Show Show 75 study locations
Sponsors and Collaborators
Amgen
Investigators
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Study Director: MD Amgen

Additional Information:
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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT02178475    
Other Study ID Numbers: 20120214
First Posted: June 30, 2014    Key Record Dates
Results First Posted: July 23, 2018
Last Update Posted: July 23, 2018
Last Verified: October 2017
Keywords provided by Amgen:
NHL
Breast Cancer
Additional relevant MeSH terms:
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Lymphoma, Non-Hodgkin
Neutropenia
Febrile Neutropenia
Chemotherapy-Induced Febrile Neutropenia
Fever
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases
Body Temperature Changes
Signs and Symptoms