Allogeneic stem cell mobilisation
| ISRCTN | ISRCTN94372129 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN94372129 |
| Protocol serial number | Rostock01 |
| Sponsor | University of Heidelberg (Universität Heidelberg) (Germany) |
| Funder | Ratiopharm GmbH (Germany) |
- Submission date
- 25/11/2011
- Registration date
- 30/03/2012
- Last edited
- 17/10/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
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
Contact information
Scientific
Universität Heidelberg
Hämatologie
Grabengasse 1
Heidelberg
69120
Germany
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Non-randomised trial |
| Secondary study design | Non randomised study |
| Study type | Participant information sheet |
| Scientific title | Application of the granulocyte colony-stimulating factor (G-CSF) biosimilar ratiograstim for the mobilisation of peripheral stem cells in healthy donors |
| Study objectives | Effectivity of the biosimilar ratiograstim is similar to original G-CSF. |
| Ethics approval(s) | Federal Authority (Bundesamt für Arzneimittel, BfArM), 21/07/2010, ref: SNR: 250906/10 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
Efficacy in peripheral stem cell mobilisation |
| Key secondary outcome measure(s) |
Safety in peripheral stem cell mobilisation |
| Completion date | 30/11/2011 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 22 |
| Key inclusion criteria | 1. Donors had no known allergy to G-CSF 2. Siblings (match-related donors) |
| Key exclusion criteria | Younger than 18 years |
| Date of first enrolment | 01/01/2010 |
| Date of final enrolment | 30/11/2011 |
Locations
Countries of recruitment
- Germany
Study participating centre
69120
Germany
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/07/2013 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
17/10/2017: Plain English summary and publication reference added.
