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

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.

Study Overview

• Status: Unknown
• Conditions: Blood Diseases
• Intervention / Treatment: Drug: FILGRASTIM

• Study Type: Observational
• Enrollment (Actual): 300

Contacts and Locations

Study Locations

• Italy
  • Torino, Italy, 10126
    • Aou Citta' Della Salute E Della Scienza Di Torino, Divisione Di Ematologia, Sscvd Trapianto Allogenico

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with Blood Cancer

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Collection of autologous stem cells (time the median of achieving> 20 CD34 + / ul circulating)		until reaching 20,000 platelets (2006-2015)
Trend in blood counts after discharge values		Until day +75 post autologous transplantation (2006-2015)
Collection of autologous stem cells (total hematopoietic stem cells CD34 + * 10 ^ 6 / kg collected)		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)	the median time (in days) from the first day of chemotherapy mobilizing the effective collection of stem cells	from the first day of chemotherapy mobilizing (2006-2015)
Collection of autologous stem cells (the median number of leukapheresis performed)		at the moment of the collection of autologous stem cells (2006-2015)
Collection of autologous stem cells (median number of white blood cells)	the median number of white blood cells in the process of mobilization	at the moment of the collection of autologous stem cells
Collection of autologous stem cells ( with the aid of Plerixafor)	the proportion of patients who have the mobilized peripheral blood stem cells with the aid of Plerixafor	at the moment of the collection of autologous stem cells (2006-2015)
Engraftment after autologous transplantation (granulocyte and platelet engraftment)	cumulative incidence of granulocyte and platelet engraftment	from transplant to engraftment (2006-2015)
Engraftment after autologous transplantation ( median time to achieve neutrophils> 500)	the median time to achieve neutrophils> 500 / ul for 3 consecutive days / platelets> 20,000 / ul for 7 consecutive days	from transplant to platelets engraftment (2006-2015)
Engraftment after autologous transplantation (the median number of days of G-CSF administration)		from transplant to engraftment (2006-2015)
Engraftment after autologous transplantation (median number of days of aplasia)		from transplant to engraftment (2006-2015)
Engraftment after autologous transplantation (median length of stay)		from transplant to engraftment (2006-2015)
Engraftment after autologous transplantation (number of transfusions)	number of transfusions of packed red cells and platelet pool / patient needed	from transplant to platelets engraftment (2006-2015)

Secondary Outcome Measures

Outcome Measure	Time Frame
transplant-related mortality	from transplant to death (if applicable) (2006-2015)
Overall survival (overall survival, OS)	to a year from autologous (2006-2015)

Collaborators and Investigators

• Sponsor: Azienda Ospedaliera San Giovanni Battista

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (Actual): May 1, 2016
• Study Completion: December 7, 2022

Study Registration Dates

• First Submitted: May 31, 2016
• First Submitted That Met QC Criteria: June 20, 2016
• First Posted (Estimate): June 21, 2016

Study Record Updates

• Last Update Posted (Estimate): June 21, 2016
• Last Update Submitted That Met QC Criteria: June 20, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: Patients
• Additional Relevant MeSH Terms: Hematologic Diseases; Physiological Effects of Drugs; Immunologic Factors; Adjuvants, Immunologic; Lenograstim
• Other Study ID Numbers: BIO-AUTO 06-15

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No