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
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 3
- 主要终点
- The incidence of FN in real-world outcome setting
研究概览
简要总结
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).
详细描述
Little is known about the real-world risk of febrile neutropenia (FN) among subjects receiving Udenyca. Udenyca was approved due to the totality of evidence under the new Food and Drug Administration (FDA) pathway 351 (k), which met all the endpoints of pharmacokinetic (PK), pharmacodynamic (PD) and immunogenicity in healthy volunteers. Udenyca is the only pegfilgrastim that has not been studied in actual patient cohorts; it has only been studied in healthy volunteers. This prospective observational cohort study is designed to estimate the risk of FN among subjects who 1) are at high risk for FN while receiving myelosuppressive chemotherapy in a real-world outcomes setting and 2) receive Udenyca for FN prophylaxis with each cycle of highly myelotoxic chemotherapy.
Study Plans: After signing the informed consent form, data collection will start at visit 1/cycle 1 (screening/enrollment [day 1]); subjects who received chemotherapy up to 1 week prior to enrollment are eligible to participate in the study.
Visit 1/cycle 1 is to coincide with day 1 (± 7 days) of the subjects' chemotherapy treatment; data collection should start at day 1/visit 1/cycle 1 of chemotherapy. Entries will be recorded during a subject's medical chart review to obtain information on demographic factors, malignancy characteristics (e.g., malignancy histology, date of initial malignancy diagnosis, stage at diagnosis, current malignancy stage, any previous cancer therapy [radiation, surgery, or chemotherapy]), relevant comorbidities, laboratory data, and relevant concomitant therapies.
Subjects' socio-demographic and clinical characteristics will be collected on the date of enrollment and include age, sex, geographic region, health plan information, socioeconomic status (employment status), body surface area, and tobacco use.
Detailed clinical information and laboratory information will be collected, including subjects' medical and treatment history, comorbid conditions, and history of any other malignancies (as well as any treatment received for these other malignancies). Additionally, subject Eastern Cooperative Oncology Group (ECOG) Performance Status, relevant concomitant medications, and any adverse events that occur throughout the study will be recorded.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Subject initiating chemotherapy regiment wtih <14 days between cytotoxic and G-CSF drug dosing.
- •Planned chemotherapy dose reduction for cycle
- •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 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:
- •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.
结局指标
主要结局
The incidence of FN in real-world outcome setting
时间窗: 24 months
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.
次要结局
- The incidence in FN in a palliative setting(24 months)
- The incidence of FN in a curative setting(24 months)
- Measure quality of life in subjects receiving Udenyca for FN prophylaxis(24 months)
- To compare the incidence of FN in subjects who switched to Udenyca(24 months)