Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Blood Diseases | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FILGRASTIM | Drug | Filgrastim | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (13)
- measure
- Collection of autologous stem cells (time the median of achieving> 20 CD34 + / ul circulating)
- timeFrame
- until reaching 20,000 platelets (2006-2015)
- measure
- Trend in blood counts after discharge values
- timeFrame
- Until day +75 post autologous transplantation (2006-2015)
- measure
- Collection of autologous stem cells (total hematopoietic stem cells CD34 + * 10 ^ 6 / kg collected)
- timeFrame
- at the moment of the collection of autologous stem cells (2006-2015)
- measure
- Collection of autologous stem cells (the median time from the first day of chemotherapy mobilizing)
- timeFrame
- from the first day of chemotherapy mobilizing (2006-2015)
- description
- the median time (in days) from the first day of chemotherapy mobilizing the effective collection of stem cells
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available