Clinical trial NCT01766934: Non-interventional, Long-term Safety Data Collection of Zarzio® / Filgrastim HEXAL® in Stem Cell Donors
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hematopoietic Stem Cell Mobilization
Keywords: Peripheral blood progenitor cell mobilization
allogenic hematopoetic stem cell transplantation
recombinant human granulocyte colony stimulating factor
filgrastim
Lead sponsor: Sandoz
Sponsor class: INDUSTRY
Collaborators: name: Hexal AG
First posted: 2013-01-11
Enrollment: 245
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adult, unrelated, healthy volunteers who received at least one dose of Sandoz' filgrastim

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.

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 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.

Primary outcomes:
measure: Incidence of drug-related adverse events following mobilization with Sandoz' filgrastim.
timeFrame: each patient will be followed for 10 years after mobilization
Secondary outcomes:
measure: Efficacy assessment in terms of the CD34+ cell count.
timeFrame: CD34+ cells are counted on 1 day immediately preceding apheresis
Other outcomes:
Locations:
city: Frankfurt/Main
country: Germany
facility: German Red Cross Blood Donor Service Baden-Wuerttemberg-Hessen, Institute for Transfusion medicine und Immunohematology Frankfurt am Main
state: Hessen
city: Ulm
country: Germany
facility: German Red Cross Blood Donor Service Baden-Wuerttemberg-Hessen, Institute for Clinical Transfusion medicine and Immunogenetics Ulm (IKT)
Study officials:
affiliation: Hexal AG
name: Hexal AG
role: STUDY_CHAIR
References:
citation: 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.