Non-interventional, Long-term Safety Data Collection of Zarzio® / Filgrastim HEXAL® in Stem Cell Donors

Hematopoietic Stem Cell Mobilization Clinical Trial

— SMART  

Official title:

Non-interventional, Prospective, Long-term Safety Data Collection of Zarzio® / Filgrastim HEXAL® in Healthy Unrelated Stem Cell Donors Undergoing Peripheral Blood Progenitor Cell Mobilization

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01766934
• Other study ID #: EP06-501
• Status: Active, not recruiting
• Start date: May 2011
• Est. completion date: August 16, 2024

Study information

• Verified date: July 2023
• Source: Sandoz
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Data collection on the safety and efficacy of Zarzio® / Filgrastim HEXAL® in adult healthy unrelated stem cell donors undergoing peripheral blood progenitor cell mobilization.

Description:

This will be a prospective, non-interventional long term data collection study. Adult healthy unrelated stem cell donors receiving Sandoz' filgrastim according to the stem cell mobilization protocols of the respective apheresis centers will be monitored for safety and efficacy during the mobilization period, and a systematic safety data follow-up will be implemented for up to 10 years after mobilization.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 245
• Est. completion date: August 16, 2024
• Est. primary completion date: August 16, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Volunteer adult healthy unrelated donors who have received at least one dose of Sandoz' filgrastim for PBPC mobilization

Exclusion Criteria:

• Donors of age <18 years

• Related to recipient

• Chronic significant organ diseases

• Systemic autoimmune diseases

• Chronic infectious diseases

• History of malignant disease

• Pregnant and breastfeeding women

• Hypersensitivity to E. coli derived proteins

• Hypersensitivity to the active substance or to any of the excipients of Sandoz' filgrastim

• Absolute and relative contraindications as specified in the SmPC of Sandoz' filgrastim

• Participation in previous stem cell mobilization procedures

• Previous or concurrent use of other mobilizing agents, e.g. plerixafor

• Informed consent was not signed prior to beginning of documentation.

Related Conditions & MeSH terms

• Hematopoietic Stem Cell Mobilization

Locations

Country	Name	City	State
Germany	German Red Cross Blood Donor Service Baden-Wuerttemberg-Hessen, Institute for Transfusion medicine und Immunohematology Frankfurt am Main	Frankfurt/Main	Hessen
Germany	German Red Cross Blood Donor Service Baden-Wuerttemberg-Hessen, Institute for Clinical Transfusion medicine and Immunogenetics Ulm (IKT)	Ulm

Sponsors (2)

Lead Sponsor	Collaborator
Sandoz	Hexal AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of drug-related adverse events following mobilization with Sandoz' filgrastim.	The primary objective is to investigate adverse events that are suspected to be related to stem cell mobilization with the Sandoz' filgrastim in healthy unrelated donors.	each patient will be followed for 10 years after mobilization
Secondary	Efficacy assessment in terms of the CD34+ cell count.	The secondary objective is to investigate the efficacy of stem cell mobilization with the Sandoz' filgrastim in terms of the CD34+ cell count.	CD34+ cells are counted on 1 day immediately preceding apheresis