MedTrace Logo

Descriptive Analysis of G-CSF Use in Patients With Breast Cancer, Lung Cancer, or Lymphoma Treated

NCT02921191 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 57725

Last updated 2023-07-27

No results posted yet for this study

Summary

Purpose:

With the existing recombinant human granulocyte colony-stimulating factors (G-CSFs) patents expiring and the FDA approval of new biosimilar and innovator biologics, patients being treated with Grade III and IV myelosuppressive chemotherapy regimens will have additional therapeutic options. This observational study will describe the patient characteristics of new users of G-CSFs. It will describe in the treatment cohorts a primary outcome of hospitalizations for febrile neutropenia. The BBCIC will use the findings from this descriptive analysis to design a comparative study evaluating the real-world effectiveness and safety of biosimilar and innovator G-CSFs.

Conditions

Interventions

DRUG

filgrastim, TBO-filgrastim or pegfilgrastim

First cycle

Sponsors & Collaborators

  • Henry Ford Health System

    collaborator OTHER

  • Aetna, Inc.

    collaborator INDUSTRY

  • Amgen

    collaborator INDUSTRY

  • College of Pharmacy, University of Nebraska College

    collaborator UNKNOWN

  • College of Pharmacy, University of New England

    collaborator UNKNOWN

  • HealthPartners Institute

    collaborator OTHER

  • Momenta Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • Harvard Pilgrim Health Care

    collaborator OTHER

  • Biologics & Biosimilars Collective Intelligence Consortium

    lead OTHER

Principal Investigators

  • Vanita Pindolia, PharmD, VP · Henry Ford Health Systems

  • Pam Pawloski, PharmD · HealthPartners Institute

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2015-09-30
Completion
2019-02-28

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02921191 on ClinicalTrials.gov