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

Non-interventional, Prospective, Long-term Safety Data Collection of Zarzio® / Filgrastim HEXAL® in Healthy Unrelated Stem Cell Donors Undergoing Peripheral Blood Progenitor Cell Mobilization

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01766934

Acronym

SMART

Enrollment

245

Registered

2013-01-11

Start date

2011-05-31

Completion date

2024-08-29

Last updated

2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hematopoietic Stem Cell Mobilization

Keywords

Peripheral blood progenitor cell mobilization, allogenic hematopoetic stem cell transplantation, recombinant human granulocyte colony stimulating factor, 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Germany

Outcome results