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OpenTrials
Completed

NCT Number: NCT01766934

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

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

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Key information

Conditions

Hematopoietic Stem Cell Mobilization

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Incidence of drug-related adverse events following mobilization with Sandoz' filgrastim.

    Time frame: 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 outcomes

  1. Efficacy assessment in terms of the CD34+ cell count.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Sandoz

Industry

Collaborators

  • Hexal AG

Registry information

Official study 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

Acronym: SMART

Important dates

Study start
2011
Primary completion
2024
Study completion
2024
First posted
Jan 11, 2013
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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