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
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Collection of autologous stem cells (time the median of achieving> 20 CD34 + / ul circulating)
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •> 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
排除标准
- 未提供
结局指标
主要结局
Collection of autologous stem cells (time the median of achieving> 20 CD34 + / ul circulating)
时间窗: until reaching 20,000 platelets (2006-2015)
Trend in blood counts after discharge values
时间窗: Until day +75 post autologous transplantation (2006-2015)
Collection of autologous stem cells (the median time from the first day of chemotherapy mobilizing)
时间窗: 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 (total hematopoietic stem cells CD34 + * 10 ^ 6 / kg collected)
时间窗: at the moment of the collection of autologous stem cells (2006-2015)
Collection of autologous stem cells (the median number of leukapheresis performed)
时间窗: at the moment of the collection of autologous stem cells (2006-2015)
Collection of autologous stem cells (median number of white blood cells)
时间窗: 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)
时间窗: 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)
时间窗: from transplant to engraftment (2006-2015)
cumulative incidence of granulocyte and platelet engraftment
Engraftment after autologous transplantation ( median time to achieve neutrophils> 500)
时间窗: 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)
时间窗: from transplant to engraftment (2006-2015)
Engraftment after autologous transplantation (median number of days of aplasia)
时间窗: from transplant to engraftment (2006-2015)
Engraftment after autologous transplantation (median length of stay)
时间窗: from transplant to engraftment (2006-2015)
Engraftment after autologous transplantation (number of transfusions)
时间窗: from transplant to platelets engraftment (2006-2015)
number of transfusions of packed red cells and platelet pool / patient needed
次要结局
- transplant-related mortality(from transplant to death (if applicable) (2006-2015))
- Overall survival (overall survival, OS)(to a year from autologous (2006-2015))
研究者
Benedetto Bruno
Program Head, Bone Marrow Transplantation Unit
Azienda Ospedaliera San Giovanni Battista