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

Sandoz

Status: Completed

Conditions: Hematopoietic Stem Cell Mobilization

Study type: Observational

Funder types: Industry

Identifiers

NCT01766934

EP06-501

Details and patient eligibility

About

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

Full 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.

Enrollment: 245 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.