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

NCT01766934 | Completed

• 1 other identifier: EP06-501
• Study Type: observational
• Target: 245
• Locations: 1 country
• Sites: 2

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.

Conditions

Hematopoietic Stem Cell Mobilization

Keywords

Peripheral blood progenitor cell mobilization; allogenic hematopoetic stem cell transplantation; recombinant human granulocyte colony stimulating factor; filgrastim

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  CD34+ cells are counted on 1 day immediately preceding apheresis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

adult, unrelated, healthy volunteers who received at least one dose of Sandoz' filgrastim

You may qualify if:

• Volunteer adult healthy unrelated donors who have received at least one dose of Sandoz' filgrastim for PBPC mobilization

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sandoz: lead
• Hexal AG: collaborator

Study Sites (2)

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

Frankfurt am Main, Hesse, 60528, Germany

Location

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

Ulm, 89081, Germany

Location

Related Publications (1)

• Heyn J, Brauninger S, Dimova-Dobreva M, Mathieson N, Koptelova N, Kolpakova A, Seidl C, Reinhardt P, Tsamadou C, Schrezenmeier H, Nakov R, Seifried E, Bonig H. Superior physical and mental health of healthy volunteers before and five years after mobilized stem cell donation. J Transl Med. 2022 Mar 14;20(1):121. doi: 10.1186/s12967-022-03322-w.

  PMID: 35287672 DERIVED

Study Officials

• Hexal AG

  Hexal AG

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2013
• First Posted: January 11, 2013
• Study Start: May 1, 2011
• Primary Completion: August 29, 2024
• Study Completion: August 29, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

DE (2)