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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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: