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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hematopoietic Stem Cell Mobilization

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peripheral blood progenitor cell mobilization, allogenic hematopoetic stem cell transplantation, recombinant human granulocyte colony stimulating factor, filgrastim