Use of Zarzio® in Post-autologous Stem Cell Transplantation Procedure

Utilisation du ZArzio® en Post-Autogreffe de Cellules Souches périphériques Des Patients Atteints de Lymphome ou Myélome (in French)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03323541

Acronym

ZAPA

Enrollment

Registered

2017-10-27

Start date

2016-11-03

Completion date

2016-12-31

Last updated

2018-09-21

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

Conditions

Hodgkin Lymphoma, Multiple Myeloma, Non-hodgkin Lymphoma

Keywords

biosimilars, filgrastim, Stem cell transplantation, lymphoma, multiple myeloma

Brief summary

There are limited data concerning the use of biosimilars of filgrastim in autologous stem cell transplantation (ASCT). This study aimed to evaluate G-CSF efficiency and safety (based on haemograms, transfusion needs and complications) of two biosimilars (Zarzio and Ratiograstim®) compared to those of Neupogen® for our patients who underwent ASCT.

Detailed description

Since 2008, Investigator collected data of all patients who underwent ASCT to treat lymphoma or myeloma. All the patients signed an institutional informed consent form before the harvest of peripheric stem cells (PROMISE program). Patients received Neupogen® (Amgen-SA) between April 2008 and February 2010, and the next group of patients was treated with Ratiograstim® (Ratiopharm GmbH) until May 2012. The last group of patients received Zarzio® (Sandoz GmbH) until November 2014. Investigator studied the impact of the Zarzio® use on biological parameters of the bone marrow recovery, transfusion needs and infectious complications. These parameters were then compared to those of the previous patients which were treated with the two other drugs. The patients were recruited in the University Hospital of Brest. They were consecutive patients, treated by ASCT for their high risk lymphoma and myeloma but without selection.

Interventions

DRUGFilgrastim Prefilled Syringe [Zarzio®]

Daily subcutaneous injection of Zarxio post ASCT, from day 5 until bone marrow recovery (neutrophils \>1 giga/l)

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* patients with DLBCL or multiple myeloma * patients who underwent ASCT in our hospital * patients treated by Zarzio® in post-ASCT phase to accelerate the bone marrow recovery

Exclusion criteria

* patients who underwent ASCT but for other diseases * patients who underwent ASCT for the required diseases but treated with an other biosimilar of Filgrastim * patients who did not sign the informed consent

Design outcomes

Primary

Measure	Time frame	Description
time to bone marrow recovery	daily evaluation, around 8 days normally	timing in days from the day of ASCT until the day when neutrophils \>1 giga/l

Outcome results

None listed

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