Multi-level Evaluation of Chemotherapy-induced Febrile Neutropenia Prophylaxis, Outcomes, and Determinants With Granulocyte-colony Stimulating Factor (Monitor-GCSF)
This international, prospective, observational, open-label, pharmaco-epidemiologic study observes cancer patients at risk for chemotherapy-induced febrile neutropenia (FN) who are receiving filgrastim biosimilar for primary or secondary FN prophylaxis to better describe the patient population at risk for FN and treated prophylactically with filgrastim biosimilar, to describe prophylaxis patterns involving filgrastim biosimilar, and to evaluate hematology levels and variability in hematological outcomes, impact on chemotherapy delivery, radiotherapy, surgery, and mortality. Additionally the study aims to identify patient cohorts who are vulnerable to poor response to FN prophylaxis and experience break-through episodes of FN, understand the differences between prophylaxis responders and non-responders, and describe the degree to which prophylaxis of FN is in congruence with guideline recommendations.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||International, Prospective, Open-label, Multicenter, Pharmacoepidemiological Study to Determine Predictors of Clinical Outcomes in Chemotherapy-treated Cancer Patients at Risk for Febrile Neutropenia and Treated Prophylactically With Filgrastim Biosimilar.|
- Absolute neutrophil count (ANC) [ Time Frame: 6 months, 6 cycles of chemotharapy ] [ Designated as safety issue: No ]Describe intraindividual changes in ANC.
- Cohort identification and differentiation [ Time Frame: 6 months, 6 cycles of chemotherapy ] [ Designated as safety issue: No ]Patient profiles based on medical history, concomitant comorbid conditions and current clinical status.
- Nonresponder analyses [ Time Frame: 6 months, 6 cycles of chemotherapy ] [ Designated as safety issue: Yes ]
Patient- and center-level variables between patients who had:
- chemotherapy dose delays or reductions,
- surgery delays or cancellations, and
- radiotherapy delays, dose reductions or cancellations vs no such events and
- patients who died vs. survived during the course of prophylaxis with filgrastim biosimilar in all patients and those with break-through FN episodes.
|Study Start Date:||March 2010|
|Study Completion Date:||August 2013|
|Primary Completion Date:||August 2013 (Final data collection date for primary outcome measure)|
Only 1 group
Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01459653
|Znojmo, Czech Republic, 66902|
|Hôpital Européen Georges Pompidou - Service Oncologie Médicale|
|Paris, France, 75908|
|Universitaetsklinik Hamburg-Eppendorf, Med. Klinik II Onkologie, Haematologie|
|Hamburg, Germany, 20246|
|Azienda Ospedaliero Universitaria "San Giovanni Battista di Torino"|
|Torino, Italy, 10126|
|SPSK1 Klinika Hematologii|
|Lublin, Poland, 20-081|
|Centrul de Diagnostic si Tratament Euromedic Fundeni|
|Bucuresti, Romania, 022328|
|Hospital Clinic i Provincial de Barcelona|
|Barcelona, Spain, 08036|
|IMO Clinique de Genolier|
|Genolier, Switzerland, 1272|
|The Rotherham NHS Foundation Trust - Dept. of Haematology|
|Rotherham, United Kingdom, S60 2UD|
|Study Director:||Matthew Turner, PhD||Sandoz|