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

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.

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Key information

Conditions

Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Hodgkin Disease Hodgkin Lymphoma Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Non-Hodgkin Lymphoma Paraproteinemias Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Filgrastim Prefilled Syringe [Zarzio®]

Drug

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

Other names: Filgrastim prefilled syringe [Neupogen®]

Primary outcomes

time to bone marrow recovery

Time frame: daily evaluation, around 8 days normally

timing in days from the day of ASCT until the day when neutrophils >1 giga/l

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Official study title

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

Acronym: ZAPA

Important dates

Study start: 2016
Primary completion: 2016
Study completion: 2016
First posted: Oct 27, 2017
Registry last updated: Sep 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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