An Analysis to Estimate Febrile Neutropenia (FN) in Patients Receiving Udenyca

NCT04662892 | Unknown FDA Drug

• 1 other identifier: POEM v1.0
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 3

Brief 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).

Conditions

Febrile Neutropenia; Non-myeloid Malignancy

Outcome Measures

Primary Outcomes (1)

• The incidence of FN in real-world outcome setting

  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.

  24 months

Secondary Outcomes (4)

• The incidence of FN in a curative setting

  24 months

• The incidence in FN in a palliative 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

Interventions

Pegfilgrastim-Cbqv DRUG

Date, Dose, and cycle for subjects who received Udenyca will be recorded. Other FN prophylaxis such as Neulasta, or other pegfilgrastim biosimilars will be collected.

Also known as: Neulasta, pegfilgrastim biosimilar

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will comprise of individuals with biopsy-verified cancer who are receiving myelosuppressive chemotherapies and who have been prescribed Udenyca due to their high risk of febrile neutropenia.

You may qualify if:

• 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.

You may not qualify if:

• Subject initiating chemotherapy regiment wtih \<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 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.

Sponsors & Collaborators

• Coherus Oncology, Inc.: lead
• Community Clinical Oncology Research Network, LLC: collaborator

Study Sites (3)

Southern Oncology Specialists

Charlotte, North Carolina, 10320, United States

RECRUITING

Coastal Cancer Center

Myrtle Beach, South Carolina, 29572, United States

RECRUITING

Carolina Blood and Cancer Care, PA

Rock Hill, South Carolina, 29732, United States

RECRUITING

MeSH Terms

Conditions

Febrile Neutropenia

Interventions

pegfilgrastim

Condition Hierarchy (Ancestors)

Neutropenia; Agranulocytosis; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders

Study Officials

• Sashi Naidu, MD

  Carolina Blood and Cancer Care

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dhwani Mehta, MC, BCMAS

CONTACT

803-329-7772; dmehta@ccorn.net

Gabriel Hansen

CONTACT

803-329-7772; ghansen@ccorn.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2020
• First Posted: December 10, 2020
• Study Start: August 1, 2020
• Primary Completion: November 1, 2022
• Study Completion: December 15, 2022
• Last Updated: December 23, 2020

Record last verified: 2020-12

Locations

US (3)