An Analysis to Estimate Febrile Neutropenia (FN) in Patients Receiving Udenyca (NCT04662892) | Clinical Trial Compass
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An Analysis to Estimate Febrile Neutropenia (FN) in Patients Receiving Udenyca
United States200 participantsStarted 2020-08-01
Plain-language summary
This is a multicenter, prospective, observational cohort registry in subjects receiving myelosuppressive chemotherapy for a non-myeloid malignancy who are considered to be at high risk for developing febrile neutropenia (FN).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Subject ≥ 18 years of age at the time of signing the informed consent form.
✓. Subject has biopsy-proven malignancy and is starting myelosuppressive chemotherapy in the neoadjuvant/adjuvant or first line advanced/metastatic setting with at least 4 anticipated chemotherapy cycles.
✓. Subject's life expectancy \> 6 months.
✓. Subject is in a high-risk category for FN: 1) the subject is starting or has, within the past 7 days, started a myelosuppressive chemotherapy regimen with a high (\> 20%) FN risk 2) patient is on a chemotherapy regimen with an intermediate (10-20%) FN risk but is determined by his or her treating physician to be at a high-risk (therefore requiring primary prophylaxis with myeloid growth factor), or 3) patient is on secondary prophylaxis for FN (per NCCN guidelines).
✓. Subject is starting adjuvant chemotherapy, neoadjuvant chemotherapy, or first line chemotherapy in the metastatic setting and will be receiving at least 4 cycles of planned chemotherapy.
✓. Subjects already receiving any other Pegfilgrastim (switching) as a FN prophylaxis will be allowed to enroll so long as they have at least two cycles left in their planned treatment.
Exclusion criteria
✕. Subject initiating chemotherapy regiment wtih \<14 days between cytotoxic and G-CSF drug dosing.
✕. Planned chemotherapy dose reduction for cycle 1.
✕. Known history of serious allergic reactions to Pegfilgrastim or Filgrastim.
. Contraindication to short acting G-CSFs, Pegfilgrastim biosimilar PFS
✕. Currently receiving treatment in another investigational device or drug study, or
✕. Subject who has received radiation \< 2 weeks prior to study enrollment.
✕. Any co-morbidity in the opinion of the investigator that will prevent the subject from receiving chemotherapy.
✕. Subject has significant abnormalities on the most recent laboratory test prior to Screening/Enrollment per the Investigator including but not limited to the following: