EBMT NEWSLETTER | November 2014 | Volume 44 - Issue 2

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 towards the end of 2014 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.

New 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 UK.
  • Submission packages for competent authorities and ethics committees are being prepared
  • It is planned that the first patient will be recruited into this trial during the first quarter of 2015 
  1. CMV Prophylaxis (EBMT Steering Group: Per Llungman, Rafael Duarte – Sponsor = Merck, CTC = Sue Philpott)
A Phase III Randomized, Placebo-controlled Clinical Trial to Evaluate the Safety and Efficacy of MK-8228 (Letermovir) for the Prevention of Clinically Significant Human Cytomegalovirus (CMV) Infection in Adult, CMV-Seropositive Allogeneic Hematopoietic Stem Cell Transplant Recipients in Austria, Belgium, Canada, Finland, France, Germany, Italy, Japan, Lithuania, New Zealand, Poland, Romania, South Korea, Spain, Sweden, Turkey and the UK.
  • Patient recruitment began in June 2014 and is progressing well
  • Some additional site identification is ongoing by Merck with help from the EBMT Steering Group
If you have any questions about either of these trials please contact Liz Clark.

Clinical Trials Regulation

On 16 April 2014 the new CT Regulation (536/2014; repealing Directive 2001/20/EC) was adopted. It entered into force on 16 June 2014 but will not apply to clinical trials until at least 28 May 2016.

http://ec.europa.eu/health/human-use/clinical-trials/regulation/index_en.htm

The EBMT Clinical Trials Office is monitoring the changes that will be required when the Regulation comes into effect. 
Bookmark and Share