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

Completed

• Conditions: Non-hodgkin Lymphoma; Hodgkin Lymphoma; Multiple Myeloma
• Interventions: Drug: Filgrastim Prefilled Syringe [Zarzio®]

• Registration Number: NCT03323541
• Lead Sponsor: University Hospital, Brest

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.

Study Timeline

• Study Start: 2016-11-03
• Primary Completion: 2016-12-31
• Study Completion: 2016-12-31
• Study First Submitted: 2017-10-24
• Study First Submitted QC: 2017-10-24
• Study First Posted: 2017-10-27
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-20
• Last Update Posted: 2018-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group of patients treated with Zarxio	Filgrastim Prefilled Syringe [Zarzio®]	All consecutive patients, treated for lymphoma or myeloma, which underwent autologous stem cell transplantation in the University Hospital of Brest. All these patients were treated with biosimilars of Filgrastim: Zarzio®.

Primary Outcome Measures

Name	Time	Method
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