Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Results of Peripheral Blood Stem Cells According to Stimulatory Molecule,: Zarzio Versus Granocytes (ZAG)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03367117
Recruitment Status : Completed
First Posted : December 8, 2017
Last Update Posted : December 8, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Brest

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
Investigator therefore propose a retrospective mono-centric study, to compare the results obtained in patients with myeloma or lymphoma, mobilized with Zarzio® in order to obtain a graft, with the results obtained in our study. retrospective cohort of mobilization by Granocyte®.

Condition or disease
Hematology, Graft, Mobilization

Detailed Description:

Autologous cell therapy remains the standard treatment in lymphomas (Hodgkin or non Hodgkin) and myelomas in the first line if they have bad prognostic factors or second-line cases of relapsed or relapsed patients. The essential condition for performing an autograft is the existence of a graft sufficient for this procedure. The European Society of Marrow Transplantation (EBMT) recommends to inject a minimum of 2 × 10 6 CD34 + cells / kg.

Although in terms of conventional products (Neupogen® and Granocyte®), the literature is very rich, there is no data on the use of biosimilars in this indication. A PUBMED search using the terms "peripheral blood stem cell harvest, OR Zarzio® biosimilars" did not produce any results.

Zarzio® has a tolerance and efficacy profile equivalent to "classical" products when used in post-chemotherapy, primary or secondary prophylaxis.

It therefore seems important to compare its efficacy and tolerance in mobilization situations for peripheral stem cell sampling.The Investigator therefore propose a retrospective mono-centric study, to compare the results obtained in patients with myeloma or lymphoma, mobilized with Zarzio® to obtain a graft, with the results obtained in our study. retrospective cohort of mobilization by Granocyte®.

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 70 participants
Observational Model: Cohort
Time Perspective: Retrospective
Actual Study Start Date : October 10, 2016
Actual Primary Completion Date : January 23, 2017
Actual Study Completion Date : January 23, 2017
Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Stimulation by biosimilairs of Granulocyte - Colony stimulating factor ( G-CSF) [ Time Frame: Two days ]
    Utilisation of bio similairs of GCSF for stimulation in view of obtaining an autologous graft


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Lymphoma or myeloma patients for whom autologous stem cell tansplatation is a therapeutical option
Criteria

Inclusion Criteria:

  • - Age supérieur to 8 year
  • Recommandation of ABSCT

Exclusion Criteria:

  • - No indication of ABSCT
  • Age inférieur to 18 years
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

No Contacts or Locations Provided
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT03367117    
Other Study ID Numbers: ZAG
First Posted: December 8, 2017    Key Record Dates
Last Update Posted: December 8, 2017
Last Verified: October 2017

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No