Efficacy of Biosimilar Filgrastim on the Mobilization of Hematopoietic Stem Cell CD34+ (Cluster of Differentiation 34) and on the Kinetic Engraftment

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Azienda Ospedaliera San Giovanni Battista
• Treatments: Lenograstim

Criteria

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.