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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Hexal AG
Information provided by (Responsible Party):
Sandoz
ClinicalTrials.gov Identifier:
NCT01766934
First received: January 10, 2013
Last updated: March 16, 2016
Last verified: March 2016
  Purpose
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
Hematopoietic Stem Cell Mobilization

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Sandoz:

Primary Outcome Measures:
  • Incidence of drug-related adverse events following mobilization with Sandoz' filgrastim. [ Time Frame: each patient will be followed for 10 years after mobilization ] [ Designated as safety issue: No ]
    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:
  • Efficacy assessment in terms of the CD34+ cell count. [ Time Frame: CD34+ cells are counted on 1 day immediately preceding apheresis ] [ Designated as safety issue: No ]
    The secondary objective is to investigate the efficacy of stem cell mobilization with the Sandoz' filgrastim in terms of the CD34+ cell count.


Enrollment: 245
Study Start Date: May 2011
Estimated Study Completion Date: August 2024
Estimated Primary Completion Date: August 2024 (Final data collection date for primary outcome measure)
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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
adult, unrelated, healthy volunteers who received at least one dose of Sandoz' filgrastim
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01766934

Locations
Germany
German Red Cross Blood Donor Service Baden-Wuerttemberg-Hessen, Institute for Transfusion medicine und Immunohematology Frankfurt am Main
Frankfurt/Main, Hessen, Germany, 60528
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
  More Information

Responsible Party: Sandoz
ClinicalTrials.gov Identifier: NCT01766934     History of Changes
Other Study ID Numbers: EP06-501 
Study First Received: January 10, 2013
Last Updated: March 16, 2016
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Individual Participant Data  
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

Additional relevant MeSH terms:
Lenograstim
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 24, 2016