Blood Diseases Clinical Trial
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
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.
n/a
Observational Model: Cohort, Time Perspective: Retrospective
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