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

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ClinicalTrials.gov Identifier: NCT02806791
Recruitment Status : Unknown
Verified June 2016 by Benedetto Bruno, Azienda Ospedaliera San Giovanni Battista.
Recruitment status was:  Active, not recruiting
First Posted : June 21, 2016
Last Update Posted : June 21, 2016
Sponsor:
Information provided by (Responsible Party):
Benedetto Bruno, Azienda Ospedaliera San Giovanni Battista

Study Description
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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.


Condition or disease Intervention/treatment
Blood Diseases Drug: FILGRASTIM

Study Design
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Study Type : Observational
Actual Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Retrospective
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
Study Start Date : May 2016
Actual Primary Completion Date : May 2016

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Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Collection of autologous stem cells (time the median of achieving> 20 CD34 + / ul circulating) [ Time Frame: until reaching 20,000 platelets (2006-2015) ]
  2. Trend in blood counts after discharge values [ Time Frame: Until day +75 post autologous transplantation (2006-2015) ]
  3. Collection of autologous stem cells (total hematopoietic stem cells CD34 + * 10 ^ 6 / kg collected) [ Time Frame: at the moment of the collection of autologous stem cells (2006-2015) ]
  4. Collection of autologous stem cells (the median time from the first day of chemotherapy mobilizing) [ Time Frame: 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

  5. Collection of autologous stem cells (the median number of leukapheresis performed) [ Time Frame: at the moment of the collection of autologous stem cells (2006-2015) ]
  6. Collection of autologous stem cells (median number of white blood cells) [ Time Frame: at the moment of the collection of autologous stem cells ]
    the median number of white blood cells in the process of mobilization

  7. Collection of autologous stem cells ( with the aid of Plerixafor) [ Time Frame: 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

  8. Engraftment after autologous transplantation (granulocyte and platelet engraftment) [ Time Frame: from transplant to engraftment (2006-2015) ]
    cumulative incidence of granulocyte and platelet engraftment

  9. Engraftment after autologous transplantation ( median time to achieve neutrophils> 500) [ Time Frame: 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

  10. Engraftment after autologous transplantation (the median number of days of G-CSF administration) [ Time Frame: from transplant to engraftment (2006-2015) ]
  11. Engraftment after autologous transplantation (median number of days of aplasia) [ Time Frame: from transplant to engraftment (2006-2015) ]
  12. Engraftment after autologous transplantation (median length of stay) [ Time Frame: from transplant to engraftment (2006-2015) ]
  13. Engraftment after autologous transplantation (number of transfusions) [ Time Frame: from transplant to platelets engraftment (2006-2015) ]
    number of transfusions of packed red cells and platelet pool / patient needed


Secondary Outcome Measures :
  1. transplant-related mortality [ Time Frame: from transplant to death (if applicable) (2006-2015) ]
  2. Overall survival (overall survival, OS) [ Time Frame: to a year from autologous (2006-2015) ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with Blood Cancer
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02806791


Locations
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Italy
Aou Citta' Della Salute E Della Scienza Di Torino, Divisione Di Ematologia, Sscvd Trapianto Allogenico
Torino, Italy, 10126
Sponsors and Collaborators
Azienda Ospedaliera San Giovanni Battista
More Information
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Responsible Party: Benedetto Bruno, Program Head, Bone Marrow Transplantation Unit, Azienda Ospedaliera San Giovanni Battista
ClinicalTrials.gov Identifier: NCT02806791    
Other Study ID Numbers: BIO-AUTO 06-15
First Posted: June 21, 2016    Key Record Dates
Last Update Posted: June 21, 2016
Last Verified: June 2016
Keywords provided by Benedetto Bruno, Azienda Ospedaliera San Giovanni Battista:
Patients
Additional relevant MeSH terms:
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Hematologic Diseases
Lenograstim
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs