Clincosm LogoSign in Get a demo

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

Sponsor
Sandoz (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT01766934
Collaborator
Hexal AG (Industry)
245
Enrollment
2
Locations
159
Duration (Months)
122.5
Patients Per Site
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Detailed 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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    245 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    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
    Study Start Date :
    May 1, 2011
    Anticipated Primary Completion Date :
    Aug 1, 2024
    Anticipated Study Completion Date :
    Aug 1, 2024

    Outcome Measures

    Primary Outcome Measures

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

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 German Red Cross Blood Donor Service Baden-Wuerttemberg-Hessen, Institute for Transfusion medicine und Immunohematology Frankfurt am Main Frankfurt/Main Hessen Germany 60528
    2 German Red Cross Blood Donor Service Baden-Wuerttemberg-Hessen, Institute for Clinical Transfusion medicine and Immunogenetics Ulm (IKT) Ulm Germany 89081

    Sponsors and Collaborators

    • Sandoz
    • Hexal AG

    Investigators

    • Study Chair: Hexal AG, Hexal AG

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sandoz
    ClinicalTrials.gov Identifier:
    NCT01766934
    Other Study ID Numbers:
    • EP06-501
    First Posted:
    Jan 11, 2013
    Last Update Posted:
    Jan 25, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Keywords provided by Sandoz
    Peripheral blood progenitor cell mobilization
    allogenic hematopoetic stem cell transplantation
    recombinant human granulocyte colony stimulating factor
    filgrastim

    Study Results

    No Results Posted as of Jan 25, 2022