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

NCT ID: NCT03367117

Last Updated: 2017-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-10-10

Study Completion Date

2017-01-23

Brief Summary

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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

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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®.

Conditions

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Hematology, Graft, Mobilization

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Brest

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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ZAG

Identifier Type: -

Identifier Source: org_study_id