Overview

This trial is active, not recruiting.

Condition hematopoietic stem cell mobilization
Sponsor Sandoz
Collaborator Hexal AG
Start date May 2011
End date August 2024
Trial size 245 participants
Trial identifier NCT01766934, EP06-501

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Measure
Incidence of drug-related adverse events following mobilization with Sandoz' filgrastim.
time frame: each patient will be followed for 10 years after mobilization

Secondary Outcomes

Measure
Efficacy assessment in terms of the CD34+ cell count.
time frame: CD34+ cells are counted on 1 day immediately preceding apheresis

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

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
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Sandoz.