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

NCT03323541 | Completed FDA Drug

• 1 other identifier: ZAPA
• Study Type: observational
• Target: 62
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Multiple Myeloma; Non-hodgkin Lymphoma; Hodgkin Lymphoma

Keywords

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

Outcome Measures

Primary Outcomes (1)

• time to bone marrow recovery

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

  daily evaluation, around 8 days normally

Study Arms (1)

Group of patients treated with Zarxio

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®.

Drug: Filgrastim Prefilled Syringe [Zarzio®]

Interventions

Filgrastim Prefilled Syringe [Zarzio®] DRUG

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

Also known as: Filgrastim prefilled syringe [Neupogen®]

Group of patients treated with Zarxio

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients treated by ASCT in the case of DLBCL or Hodgkin disease or multiple myeloma

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Brest: lead

Related Publications (1)

• Nicol C, Henry C, Couturier MA, Delepine P, Tripogney C, Buors C, Guillerm G, Berthou C, Tempescul A, Ianotto JC. Biosimilars of filgrastim in autologous stem cell transplantation: certain differences for myeloma patients only. Leuk Lymphoma. 2017 Sep;58(9):1-3. doi: 10.1080/10428194.2017.1285025. Epub 2017 Feb 7. No abstract available.

  PMID: 28278727 RESULT

MeSH Terms

Conditions

Multiple Myeloma; Lymphoma, Non-Hodgkin; Hodgkin Disease; Lymphoma

Interventions

Filgrastim

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• IANOTTO Jean-Christophe, MD, PhD

  Hématologie Clinique-Institut de Cancéro-Hématologie

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2017
• First Posted: October 27, 2017
• Study Start: November 3, 2016
• Primary Completion: December 31, 2016
• Study Completion: December 31, 2016
• Last Updated: September 21, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share