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

Sandoz245 enrolled

Overview

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

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 Type

OBSERVATIONAL

Enrollment

245

Conditions

Hematopoietic Stem Cell Mobilization

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (2)

German Red Cross Blood Donor Service Baden-Wuerttemberg-Hessen, Institute for Transfusion medicine und Immunohematology Frankfurt am Main

Frankfurt am Main, Hesse, Germany

German Red Cross Blood Donor Service Baden-Wuerttemberg-Hessen, Institute for Clinical Transfusion medicine and Immunogenetics Ulm (IKT)

Ulm, Germany

Outcomes

Primary Outcomes

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.

Time frame: each patient will be followed for 10 years after mobilization

Secondary Outcomes

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.

Time frame: CD34+ cells are counted on 1 day immediately preceding apheresis

Data from ClinicalTrials.gov

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