Blood Diseases
Conditions
Keywords
Patients
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.
Interventions
DRUGFILGRASTIM
Sponsors
Azienda Ospedaliera San Giovanni Battista
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Engraftment after autologous transplantation (number of transfusions) | from transplant to platelets engraftment (2006-2015) | number of transfusions of packed red cells and platelet pool / patient needed |
| 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) | — |
| 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) | from the first day of chemotherapy mobilizing (2006-2015) | the median time (in days) from the first day of chemotherapy mobilizing the effective collection of stem cells |
| 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) | at the moment of the collection of autologous stem cells | the median number of white blood cells in the process of mobilization |
| Collection of autologous stem cells ( with the aid of Plerixafor) | at the moment of the collection of autologous stem cells (2006-2015) | the proportion of patients who have the mobilized peripheral blood stem cells with the aid of Plerixafor |
| Engraftment after autologous transplantation (granulocyte and platelet engraftment) | from transplant to engraftment (2006-2015) | cumulative incidence of granulocyte and platelet engraftment |
| Engraftment after autologous transplantation ( median time to achieve neutrophils> 500) | from transplant to platelets engraftment (2006-2015) | the median time to achieve neutrophils\> 500 / ul for 3 consecutive days / platelets\> 20,000 / ul for 7 consecutive days |
| Engraftment after autologous transplantation (the median number of days of G-CSF administration) | from transplant to engraftment (2006-2015) | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival (overall survival, OS) | to a year from autologous (2006-2015) |
| transplant-related mortality | from transplant to death (if applicable) (2006-2015) |
Countries
Italy
Outcome results
None listed