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

Active, not recruiting

• Conditions: Hematopoietic Stem Cell Mobilization

• Registration Number: NCT01766934
• Lead Sponsor: Sandoz

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2013-01-10
• Study First Submitted QC: 2013-01-10
• Study First Posted: 2013-01-11
• Status Verified: 2023-07
• Last Update Submitted: 2024-06-07
• Last Update Posted: 2024-06-10
• Primary Completion: 2024-08-16
• Study Completion: 2024-08-16

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 245

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of drug-related adverse events following mobilization with Sandoz' filgrastim.	each patient will be followed for 10 years after mobilization	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.

Secondary Outcome Measures

Name	Time	Method
Efficacy assessment in terms of the CD34+ cell count.	CD34+ cells are counted on 1 day immediately preceding apheresis	The secondary objective is to investigate the efficacy of stem cell mobilization with the Sandoz' filgrastim in terms of the CD34+ cell count.

Trial Locations

Locations (2)

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, Germany