CCorn

A Disease Registry Encompassing the Care of Patients With Prophylaxis of FN related to Non-myeloid Malignancies (POEM)

This is a multicenter, prospective, observational cohort registry in subjects receiving myelosuppressive chemotherapy for a non-myeloid malignancy and are considered at high risk for developing FN.

Condition or disease: Prophylaxis of FN related to Non-myeloid Malignancies
Intervention/treatment: Drug: Udenyca

Study Design

Study Type: Observational [Patient Registry]
Estimated Enrollment: 200 Participants
Time Perspective: Prospective
Target Follow-Up Duration: 24 Months
Official Title: A Disease Registry Encompassing the Care of Patients With Prophylaxis of FN related to Non-myeloid Malignancies (POEM)
Estimated Study Start Date: July 2020
Estimated Primary Completion Date: September 2022
Estimated Study Completion Date: December 2022

Groups and Cohorts

Intervention Details:

Drug: Udenyca
non-interventional study

Outcome Measures

Primary Outcome Measure:

To estimate the incidence of FN among subjects treated with myelosuppressive chemotherapy for the treatment of non-myeloid malignancies and receiving Udenyca with every administered chemotherapy cycle for FN prophylaxis in the real-world outcomes setting.

Eligibility Criteria

Ages Eligible for Study: 18 years and older (Adult, Older Adult)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Sampling Method: Non-Probability Sample

Study Population

The study will be comprised of individuals with biopsy-proven cancer who are receiving myelosuppressive chemotherapies and who have been prescribed Udenyca due to high-risk of Febrile Neutropenia (FN).

Criteria

Inclusion Criteria:

Subject ≥ 18 years of age at the time of signing the Informed Consent Form
Subject with biopsy-proven malignancy 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 in a high-risk category for FN such as: 1) Patient is starting or has recently (within the past 7 days) started myelosuppressive chemotherapy regimen with a high FN risk > 20%, 2) patient is on a chemotherapy regimen considered intermediate FN risk 10% to 20% risk but is determined by treating physician to be at high-risk therefore requiring primary prophylaxis with myeloid growth factor, or 3) patient is on secondary prophylaxis for FN(PER NCCN GUIDELINES)
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
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 planned treatment

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, Pegfilgrastim biosimilar PFS
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
Subject who has received radiation < 2 weeks prior to study enrollment
Any co-morbidity 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), 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