Clinical trial · Observational
An Analysis to Estimate Febrile Neutropenia (FN) in Patients Receiving Udenyca
A Prospective Observational Registry Study for Real-World Outcome Analysis to Estimate the Incidence of FN Among Subjects Who Are at High Risk for FN, Have Non-myeloid Malignancies, and Are Receiving Udenyca for Prophylaxis of FN
NCT04662892CI-TRIAL-00049100POEMunknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Febrile Neutropenia | — | UNRESOLVED | — |
| Non-myeloid Malignancy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pegfilgrastim-Cbqv | Drug | Pegfilgrastim | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- The incidence of FN in real-world outcome setting
- timeFrame
- 24 months
- description
- Calculation of the incidence of FN (as defined by NCCN) among subjects in a real-world outcome setting who are 1) being treated with myelosuppressive chemotherapy for the treatment of non- myeloid malignancies and 2) receiving Udenyca with every administered chemotherapy cycle for FN prophylaxis.
Secondary outcomes (4)
- measure
- The incidence of FN in a curative setting
- timeFrame
- 24 months
- description
- Calculation of the incidence of FN (as defined by NCCN) among subjects in a curative setting who are 1) being treated with myelosuppressive chemotherapy for the treatment of non-myeloid malignancies and 2) receiving Udenyca with every administered chemotherapy cycle for FN prophylaxis
- measure
- The incidence in FN in a palliative setting
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Subject ≥ 18 years of age at the time of signing the informed consent form. 2. 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. 3. Subject's life expectancy \> 6 months. 4. 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). 5. 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. 6. 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: 1. Subject initiating chemotherapy regiment wtih \<14 days between cytotoxic and G-CSF drug dosing. 2. Planned chemotherapy dose reduction for cycle 1. 3. Known history of serious allergic reactions to Pegfilgrastim or Filgrastim. 4. Contraindication to short acting G-CSFs, Pegfilgrastim biosimilar PFS 5. Currently receiving treatment in another investigational device or drug study, or ≤ 28 days before screening/enrollment since ending treatment on another investigational device or drug study. 6. Subject who has received radiation \< 2 weeks prior to study enrollment. 7. Any co-morbidity in the opinion of the investigator that will prevent the subject from receiving chemotherapy. 8. Subject has significant abnormalities on the most recent laboratory test prior to Screening/Enrollment per the Investigator including but not limited to the following: white blood cell (WBC) \< 4, ANC \< lower limit of normal (LLN), hemoglobin \< 10 g/dL, hematocrit \< 30%, platelet count \< 100,000, creatinine ≥ 1.5 or glomerular filtration rate \< 30 (as calculated by Cockcroft-Gault Equation), total bilirubin ≥ 2.0, aspartate aminotransferase/alanine aminotransferase (AST/ALT) ≥ 3 x upper limit of normal (ULN), subject without liver metastasis or AST/ALT ≥ 5 ULN in a subject with liver metastasis 9. Known human immunodeficiency virus (HIV) infection by history. 10. History of solid organ or stem cell transplant.
References
Publications (0)
Data not yet available
No reference posted for this study.