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

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ClinicalTrials.gov Identifier: NCT02921191
Recruitment Status : Unknown
Verified September 2016 by Biologics & Biosimilars Collective Intelligence Consortium.
Recruitment status was:  Active, not recruiting
First Posted : October 3, 2016
Last Update Posted : October 7, 2016
Sponsor:
Collaborators:
Henry Ford Health System
Aetna, Inc.
Amgen
College of Pharmacy, University of Nebraska College
College of Pharmacy, University of New England
HealthPartners Institute
Momenta Pharmaceuticals, Inc.
Harvard Pilgrim Health Care
Information provided by (Responsible Party):
Biologics & Biosimilars Collective Intelligence Consortium

Brief 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.


Condition or disease Intervention/treatment
Breast Cancer Lung Cancer Drug: filgrastim, TBO-filgrastim or pegfilgrastim

Detailed Description:

Additional information:

To most effectively interpret results from this descriptive analysis it is important to consider that this protocol was not designed to support a hypothesis. This information is being provided to the public in the interest of transparency and for demonstrating the BBCIC's Distributed Research Network's (DRN) ability to define exposures, outcomes, covariates and confounders. When published, the report will caution that the protocol does not support any ability to compare safety or effectiveness but instead is to be used only to explore the feasibility of future, more detailed comparative analyses and to better understand the capabilities of the BBCIC project. Further, the report will caution that information from this protocol should not affect use of the medical products described in any way and the fact that the BBCIC is performing this descriptive analysis in no way suggests there is a safety or effectiveness issue with any of the products described.


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Study Type : Observational
Estimated Enrollment : 100000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Descriptive Analysis of First-Cycle Prophylactic Use of G-CSF in Patients With Breast Cancer, Lung Cancer, or Lymphoma Treated With High Neutropenia Risk Chemotherapy
Study Start Date : January 2008
Actual Primary Completion Date : September 2015
Estimated Study Completion Date : February 2017


Group/Cohort Intervention/treatment
Lung cancer
Lung cancer patients receiving their first cycle of Grade III and IV myelosuppressive chemotherapy regimen treated prophylactically with G-CSF.
Drug: filgrastim, TBO-filgrastim or pegfilgrastim
First cycle
Other Name: Neupogen, Neulasta, Granix, Zarxio

Breast cancer
Breast cancer patients receiving their first cycle of Grade III and IV myelosuppressive chemotherapy regimen treated prophylactically with G-CSF (filgrastim, TBO-filgrastim or pegfilgrastim)
Drug: filgrastim, TBO-filgrastim or pegfilgrastim
First cycle
Other Name: Neupogen, Neulasta, Granix, Zarxio




Primary Outcome Measures :
  1. Hospitalizations for severe neutropenia [ Time Frame: Anticipated completion February 2017 ]
    Primary: Incidence of hospitalizations for febrile neutropenia in patients with breast or lung cancer receiving their first cycle of Grade III and IV myelosuppressive chemotherapy regimen treated prophylactically with G-CSF


Secondary Outcome Measures :
  1. Incidence severe neutropenia [ Time Frame: Anticipated completion February 2017 ]
    Incidence severe neutropenia (ANC<0.5g/l)



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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
Study subjects are selected according to inclusion criteria from a source population within the Sentinel Common Data Mode v5.0.1 (SCDM). The SCDM includes over 100 million individuals with 358 million person-years of observation time who are covered by Aetna, Anthem, Group Health Cooperative, Harvard Pilgrim Health Care, and HealthPartners. The time period assessed will be 1/1/2008-9/30/2015.
Criteria

Inclusion Criteria:

  • Individuals with baseline period of 183 days with continuous medical and pharmacy coverage preceding the first prescription fill for G-CSF
  • Breast or lung cancer patients receiving their first cycle of Grade III and IV myelosuppressive chemotherapy regimen treated prophylactically with G-CSF.

Exclusion Criteria:

During baseline 365 days, any patient with a claim for (or with)

  • Chemotherapy drug.
  • Skilled nursing facility (SNF) or hospice care
  • Diagnosis for a secondary breast cancer diagnosis
  • A second cancer diagnosis (i.e., not breast, lung, lymphoma)
  • Bone marrow or stem cell transplant
  • Radiotherapy
  • Chemo cycle >First: (exclude any chemotherapy cycles post the index G-CSF date)
  • HIV/AIDS
  • Hepatic disease
  • Other non-oncology related neutropenia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02921191


Sponsors and Collaborators
Biologics & Biosimilars Collective Intelligence Consortium
Henry Ford Health System
Aetna, Inc.
Amgen
College of Pharmacy, University of Nebraska College
College of Pharmacy, University of New England
HealthPartners Institute
Momenta Pharmaceuticals, Inc.
Harvard Pilgrim Health Care
Investigators
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Principal Investigator: Vanita Pindolia, PharmD, VP Henry Ford Health Systems
Principal Investigator: Pam Pawloski, PharmD HealthPartners Institute

Additional Information:
Publications:
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Responsible Party: Biologics & Biosimilars Collective Intelligence Consortium
ClinicalTrials.gov Identifier: NCT02921191     History of Changes
Other Study ID Numbers: BBCIC -GCFs
First Posted: October 3, 2016    Key Record Dates
Last Update Posted: October 7, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: BBCIC Charter requires transparency and publication
Keywords provided by Biologics & Biosimilars Collective Intelligence Consortium:
recombinant human granulocyte colony-stimulating factors
G-CSFs
biosimilar
biologics
High Neutropenia Risk Chemotherapy
Biologic and Biosimilars Collective Intelligence Consortium
bbcic
Additional relevant MeSH terms:
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Breast Neoplasms
Lung Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Lenograstim
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs