Efficacy of Biosimilar Filgrastim on the Mobilization of Hematopoietic Stem Cell CD34+ (Cluster of Differentiation 34) and on the Kinetic Engraftment
1 other identifier
observational
300
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedFirst Submitted
Initial submission to the registry
May 31, 2016
CompletedFirst Posted
Study publicly available on registry
June 21, 2016
CompletedJune 21, 2016
June 1, 2016
Same day
May 31, 2016
June 20, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (13)
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 Outcomes (2)
transplant-related mortality
from transplant to death (if applicable) (2006-2015)
Overall survival (overall survival, OS)
to a year from autologous (2006-2015)
Interventions
Eligibility Criteria
Patients with Blood Cancer
You may qualify if:
- \> 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
You may not qualify if:
- N.A.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Aou Citta' Della Salute E Della Scienza Di Torino, Divisione Di Ematologia, Sscvd Trapianto Allogenico
Torino, 10126, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Program Head, Bone Marrow Transplantation Unit
Study Record Dates
First Submitted
May 31, 2016
First Posted
June 21, 2016
Study Start
May 1, 2016
Primary Completion
May 1, 2016
Last Updated
June 21, 2016
Record last verified: 2016-06