Overview

This trial is active, not recruiting.

Condition blood diseases
Treatment filgrastim
Sponsor Azienda Ospedaliera San Giovanni Battista
Start date May 2016
End date May 2016
Trial size 300 participants
Trial identifier NCT02806791, BIO-AUTO 06-15

Summary

The endogenous growth factor granulocyte (G-CSF) stimulates the proliferation and differentiation of hematopoietic progenitors commissioned to mature as neutrophils and activated granulocytes mature neutrophils. In the field of hematology oncology G-CSF it is used to reduce the duration and complications of chemotherapy-induced neutropenia and to stimulate the mobilization and subsequent collection of circulating hematopoietic stem cells in order to use them for autologous transplantation procedure.

Filgrastim and Lenograstim originator are marketed for many years and are considered the reference molecules for the production of biosimilar.

For several years it is available and entered into common clinical practice the use of filgrastim biosimilar (Bio-GCSF) in treating the patient oncohematologic.

Aim of the study is to analyze retrospectively a large series of patients and assess the impacts of the Bio-GCSF on the collection of hematopoietic stem cells and recovery of blood counts post autologous transplantation; the data will be compared with a historical cohort of reference that has been treated with G-CSF originator.

The study results will not generate any diagnostic or therapeutic intervention in patients still alive.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective retrospective

Primary Outcomes

Measure
Collection of autologous stem cells (time the median of achieving> 20 CD34 + / ul circulating)
time frame: until reaching 20,000 platelets (2006-2015)
Trend in blood counts after discharge values
time frame: Until day +75 post autologous transplantation (2006-2015)
Collection of autologous stem cells (total hematopoietic stem cells CD34 + * 10 ^ 6 / kg collected)
time frame: at the moment of the collection of autologous stem cells (2006-2015)
Collection of autologous stem cells (the median time from the first day of chemotherapy mobilizing)
time frame: from the first day of chemotherapy mobilizing (2006-2015)
Collection of autologous stem cells (the median number of leukapheresis performed)
time frame: at the moment of the collection of autologous stem cells (2006-2015)
Collection of autologous stem cells (median number of white blood cells)
time frame: at the moment of the collection of autologous stem cells
Collection of autologous stem cells ( with the aid of Plerixafor)
time frame: at the moment of the collection of autologous stem cells (2006-2015)
Engraftment after autologous transplantation (granulocyte and platelet engraftment)
time frame: from transplant to engraftment (2006-2015)
Engraftment after autologous transplantation ( median time to achieve neutrophils> 500)
time frame: from transplant to platelets engraftment (2006-2015)
Engraftment after autologous transplantation (the median number of days of G-CSF administration)
time frame: from transplant to engraftment (2006-2015)
Engraftment after autologous transplantation (median number of days of aplasia)
time frame: from transplant to engraftment (2006-2015)
Engraftment after autologous transplantation (median length of stay)
time frame: from transplant to engraftment (2006-2015)
Engraftment after autologous transplantation (number of transfusions)
time frame: from transplant to platelets engraftment (2006-2015)

Secondary Outcomes

Measure
transplant-related mortality
time frame: from transplant to death (if applicable) (2006-2015)
Overall survival (overall survival, OS)
time frame: to a year from autologous (2006-2015)

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: - > 18 years with history of autologous transplant - hematological diseases including: - Multiple Myeloma - Hodgkin's Lymphoma - Non-Hodgkin lymphoma B and T - Lymphocytic leukemia - Acute myeloid leukemia Exclusion Criteria: - N.A.

Additional Information

Official title Efficacy of Biosimilar Filgrastim on the Mobilization of Hematopoietic Stem Cell CD34+ (Cluster of Differentiation 34) and on the Kinetic Engraftment After Autologous Transplant in Patients With Blood Cancers
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Azienda Ospedaliera San Giovanni Battista.