Results of Peripheral Blood Stem Cells According to Stimulatory Molecule,: Zarzio Versus Granocytes
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University Hospital, Brest
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Stimulation by biosimilairs of Granulocyte - Colony stimulating factor ( G-CSF)
Study Overview
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •- Age supérieur to 8 year
- •Recommandation of ABSCT
Exclusion Criteria
- •- No indication of ABSCT
- •Age inférieur to 18 years
Outcomes
Primary Outcomes
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
Secondary Outcomes
No secondary outcomes reported
