Overview

This trial is active, not recruiting.

Conditions breast cancer, lung cancer
Treatment filgrastim, tbo-filgrastim or pegfilgrastim
Sponsor Biologics & Biosimilars Collective Intelligence Consortium
Collaborator Henry Ford Health System
Start date January 2008
End date September 2015
Trial size 100000 participants
Trial identifier NCT02921191, BBCIC -GCFs

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective retrospective
Arm
Lung cancer patients receiving their first cycle of Grade III and IV myelosuppressive chemotherapy regimen treated prophylactically with G-CSF.
filgrastim, tbo-filgrastim or pegfilgrastim Neupogen, Neulasta, Granix, Zarxio
First cycle
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)
filgrastim, tbo-filgrastim or pegfilgrastim Neupogen, Neulasta, Granix, Zarxio
First cycle

Primary Outcomes

Measure
Hospitalizations for severe neutropenia
time frame: Anticipated completion February 2017

Secondary Outcomes

Measure
Incidence severe neutropenia
time frame: Anticipated completion February 2017

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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
Principal investigator Vanita Pindolia, PharmD, VP
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Biologics & Biosimilars Collective Intelligence Consortium.