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

Completed

• Conditions: Hematology, Graft, Mobilization

• Registration Number: NCT03367117
• Lead Sponsor: University Hospital, Brest

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®.

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 Timeline

• Study Start: 2016-10-10
• Primary Completion: 2017-01-23
• Study Completion: 2017-01-23
• Status Verified: 2017-10
• Study First Submitted: 2017-12-04
• Study First Submitted QC: 2017-12-07
• Last Update Submitted: 2017-12-07
• Study First Posted: 2017-12-08
• Last Update Posted: 2017-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• • Age supérieur to 8 year
• Recommandation of ABSCT

Exclusion Criteria

• • No indication of ABSCT
• Age inférieur to 18 years

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Stimulation by biosimilairs of Granulocyte - Colony stimulating factor ( G-CSF)	Two days	Utilisation of bio similairs of GCSF for stimulation in view of obtaining an autologous graft