Ignite Creation Date:
2024-05-06 @ 8:42 AM
Last Modification Date:
2024-10-26 @ 12:04 PM
Study NCT ID:
NCT02806791
Status:
UNKNOWN
Last Update Posted:
2016-06-21
First Post:
2016-05-31
Brief Title:
Efficacy of Biosimilar Filgrastim on the Mobilization of Hematopoietic Stem Cell CD34 Cluster of Differentiation 34 and on the Kinetic Engraftment
Sponsor:
Azienda Ospedaliera San Giovanni Battista
Organization:
Azienda Ospedaliera San Giovanni Battista
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2016-06
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None