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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03367117
Acronym
ZAG
Enrollment
70
Registered
2017-12-08
Start date
2016-10-10
Completion date
2017-01-23
Last updated
2026-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hematology, Graft, Mobilization

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®.

Interventions

None listed

Sponsors

University Hospital, Brest
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* \- Age supérieur to 8 year * Recommandation of ABSCT

Exclusion criteria

* \- No indication of ABSCT * Age inférieur to 18 years

Design outcomes

Primary

MeasureTime frameDescription
Stimulation by biosimilairs of Granulocyte - Colony stimulating factor ( G-CSF)Two daysUtilisation of bio similairs of GCSF for stimulation in view of obtaining an autologous graft

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 4, 2026