EBMT NEWSLETTER | January 2015 | Volume 45 - Issue 3

EBMT
Important dates
The EBMT Clinical Trials Office is pleased to report that it is currently working on new prospective clinical trials and it will continue to expand the portfolio over the coming years. Hence…

The CT2 committee will reopen for new proposals in January 2015

Please consult the EBMT website for further information, which will be updated (following the January 2015 EBMT board meeting) with deadline dates and the updated guidance documents. If you have any questions about the proposal process, please contact liz.clark@ebmt.org.

Please remember that any new CT proposals must be discussed within your working party including the WP statistician before they are submitted to the CT2 committee.

Ongoing Clinical Trials

The EBMT Clinical Trials Office is currently working on two new prospective clinical trials in addition to the older trials that are in long-term follow-up.
  1. RACE (PI’s: Regis Peffault de Latour, Antonio M Risitano – Sponsor = EBMT, CTC = Astrid Hoeppener):
    A prospective Randomized multicenter study comparing horse Antithymocyte globuline (hATG) + Cyclosporine A (CsA) with or without Eltrombopag as front-line therapy for severe aplastic anemia patients in France, Italy, Germany, Netherlands, Spain, Switzerland and the UK.
  • Submissions are ongoing (the first submission was made to the Parisian  Ethical Committee in Dec 2014)
  • It is planned that the first patient will be recruited into this trial during the first half of 2015 
  1. The CMV Prophylaxis trial (EBMT Steering Group: Per Llungman, Rafael Duarte – Sponsor = Merck, CTC = Sue Philpott) is progressing well. At the end of 2014, over 100 patients had been randomised into the trial.Other trials are still in long term follow up and/or undergoing analysis

EFGCP Annual Conference 2015

The European Forum for Good Clinical Practice will hold its annual conference on 27 & 28 January 2015, in Brussels, on How do We Improve Health without Betraying Confidentiality within Current and Upcoming EU Regulations?

Further details, including registration details are available at the link below:
http://www.efgcp.eu/Conference_details.asp?id=361&L1=10&L2=1&TimeRef=1
 
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