Condition category
Surgery
Date applied
25/11/2011
Date assigned
30/03/2012
Last edited
17/10/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Stem cell mobilization is a process where drugs are used to cause the movement of stem cells so that they can be collected and used for a stem cell transplant. The drug ratiograstim has been approved for the mobilization of peripheral stem cells (from the bloodstream). The aim of this study is to assess the effectiveness and safety of peripheral stem cell mobilization by either ratiograstim or the reference drug G-CSF.

Who can participate?
Patients undergoing a stem cell transplant for hematological malignancies (cancers that affect the blood and lymph system) and their related healthy donors

What does the study involve?
Participating donors are treated with either ratiograstim or G-CSF and the effectiveness and safety of the two drugs is compared.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
Universität Heidelberg (Germany)

When is the study starting and how long is it expected to run for?
January 2010 to November 2011

Who is funding the study?
Ratiopharm GmbH (Germany)

Who is the main contact?
Prof. Michael Schmitt

Trial website

Contact information

Type

Scientific

Primary contact

Prof Michael Schmitt

ORCID ID

Contact details

Universität Heidelberg
Hämatologie
Grabengasse 1
Heidelberg
69120
Germany

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Rostock01

Study information

Scientific title

Application of the granulocyte colony-stimulating factor (G-CSF) biosimilar ratiograstim for the mobilisation of peripheral stem cells in healthy donors

Acronym

Study hypothesis

Effectivity of the biosimilar ratiograstim is similar to original G-CSF.

Ethics approval

Federal Authority (Bundesamt für Arzneimittel, BfArM), 21/07/2010, ref: SNR: 250906/10

Study design

Non-randomised trial

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please contact mathias.freund@onkologie-rostock.de to request a patient information sheet

Condition

Allogeneic stem cell transplantation

Intervention

Two cohorts, one cohort of 11 patients and donors receiving the biosimilar Ratiograstim® versus another cohort of 11 patients and donors receiving reference G-CSF. Results in this study arm were compared with results of a matched historical control

Intervention type

Procedure/Surgery

Phase

Not Applicable

Drug names

Primary outcome measures

Efficacy in peripheral stem cell mobilisation

Secondary outcome measures

Safety in peripheral stem cell mobilisation

Overall trial start date

01/01/2010

Overall trial end date

30/11/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Donors had no known allergy to G-CSF
2. Siblings (match-related donors)

Participant type

Mixed

Age group

Adult

Gender

Both

Target number of participants

22

Participant exclusion criteria

Younger than 18 years

Recruitment start date

01/01/2010

Recruitment end date

30/11/2011

Locations

Countries of recruitment

Germany

Trial participating centre

Universität Heidelberg
Heidelberg
69120
Germany

Sponsor information

Organisation

University of Heidelberg (Universität Heidelberg) (Germany)

Sponsor details

c/o Prof. Dr. med. michael schmitt
Hämatologie
Grabengasse 1
Heidelberg
69117
Germany

Sponsor type

University/education

Website

Funders

Funder type

Industry

Funder name

Ratiopharm GmbH (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2013 results in: https://www.ncbi.nlm.nih.gov/pubmed/23318540

Publication citations

Additional files

Editorial Notes

17/10/2017: Plain English summary and publication reference added.