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

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02806791
• Other study ID #: BIO-AUTO 06-15
• Status: Active, not recruiting
• Phase: N/A
• First received: May 31, 2016
• Last updated: June 20, 2016
• Start date: May 2016

Study information

• Verified date: June 2016
• Source: Azienda Ospedaliera San Giovanni Battista
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Blood Diseases
• Hematologic Diseases

Intervention

Drug:
• FILGRASTIM

Locations

Country	Name	City	State
Italy	Aou Citta' Della Salute E Della Scienza Di Torino, Divisione Di Ematologia, Sscvd Trapianto Allogenico	Torino

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera San Giovanni Battista

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Collection of autologous stem cells (time the median of achieving> 20 CD34 + / ul circulating)		until reaching 20,000 platelets (2006-2015)	Yes
Primary	Trend in blood counts after discharge values		Until day +75 post autologous transplantation (2006-2015)	Yes
Primary	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)	Yes
Primary	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)	Yes
Primary	Collection of autologous stem cells (the median number of leukapheresis performed)		at the moment of the collection of autologous stem cells (2006-2015)	Yes
Primary	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	Yes
Primary	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)	Yes
Primary	Engraftment after autologous transplantation (granulocyte and platelet engraftment)	cumulative incidence of granulocyte and platelet engraftment	from transplant to engraftment (2006-2015)	Yes
Primary	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)	Yes
Primary	Engraftment after autologous transplantation (the median number of days of G-CSF administration)		from transplant to engraftment (2006-2015)	Yes
Primary	Engraftment after autologous transplantation (median number of days of aplasia)		from transplant to engraftment (2006-2015)	Yes
Primary	Engraftment after autologous transplantation (median length of stay)		from transplant to engraftment (2006-2015)	Yes
Primary	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)	Yes
Secondary	transplant-related mortality		from transplant to death (if applicable) (2006-2015)	Yes
Secondary	Overall survival (overall survival, OS)		to a year from autologous (2006-2015)	Yes