Last updated on August 2019

A Prospective Observational Study to Estimate the Incidence of Febrile Neutropenia (FN) Among Subjects With Non-myeloid Malignancies at High Risk for FN and Receiving Neulasta® (pegfilgrastim) Onpro® kit or Other Physician Choice Options for Prophylaxis of FN


Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Neutropenia
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

Inclusion Criteria

  • Subject ≥ 18 years of age at the time of signing the informed consent form.
  • Subject with biopsy-proven breast cancer, lung cancer, NHL or prostate cancer starting myelosuppressive chemotherapy in the neoadjuvant/adjuvant or first line advanced/metastatic setting with at least 4 anticipated chemotherapy cycles.
  • Life expectancy > 6 months
  • Subject is starting or has recently (within the past 7 days) started myelosuppressive chemotherapy regimen with every 3 or 4-week cycle with a high FN risk > 20%, OR intermediate FN risk 10% to 20% risk (refer to Appendix E [only regimens listed within this appendix are allowed for enrollment]) and at least 1 risk factor for FN per Appendix F. Addition of non-cytotoxic targeted agents (eg, monoclonal antibodies, anti-angiogenic agents, and kinase inhibitors) to the listed chemotherapy regimens is permitted.
  • Subject who 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.

 

Exclusion Criteria

  • Subject initiating chemotherapy regimen with < 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, Neulasta PFS, pegfilgrastim biosimilar PFS, or Neulasta Onpro kit.
  • 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(ies).
  • Subject who started first line chemotherapy for metastatic disease who completed adjuvant/neoadjuvant chemotherapy < 6 months prior to study enrollment.
  • Subject who has received radiation < 2 weeks prior to study enrollment.
  • Any co-morbidity (refer to Appendix H) in the opinion of investigator 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:
    • 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), and a subject without liver metastasis or AST/ALT ≥ 5 ULN in a subject with liver metastasis
  • Known human immunodeficiency virus (HIV) infection by history.
  • History of solid organ or stem cell transplant.
  • Concurrent primary cancers except non-melanoma skin cancer, or adequately treated carcinoma in situ (CIS).

Recruitment Status: Closed


Brief Description Eligibility Contact Research Team


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