race trial · format (84,1cm x 118,9cm) research poster. you can use it to create your poster that...
TRANSCRIPT
www.ebmt.org #EBMT16
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DESIGN GUIDE
This PowerPoint template produces a standard A0
format (84,1cm x 118,9cm) research poster. You can
use it to create your poster that will be displayed on
the EBMT stand. This template will save valuable
time placing titles, subtitles, text, and graphics, and
it will allow homogeneity throughout the various
posters.
QUICK START
Select desired layout When designing your own poster, you will be able to choose
between the two proposed layouts - the single or the double
column - according to the information you will have to
present.
Simply click right on the slide>layout: office theme, single
column or double column
Title, Authors, and Affiliations Start designing your poster by adding the title and subtitle,
the names of the authors, and the affiliated institutions. This
titles are indicative and you can change the type of
information.
Adding Sponsor logos Do not remove or move the EBMT logo. You can insert a logo
(of a sponsor for instance) where the red frame is. Logos
taken from web sites are likely to be low quality when
printed. Zoom it at 100% to see what the logo will look like
on the final poster and make any necessary adjustments.
Photographs / Graphics You can add images by dragging and dropping from your
desktop, copy and paste, or by going to INSERT > PICTURES.
Resize images proportionally by holding down the SHIFT key
and dragging one of the corner handles. For a professional-
looking poster, do not distort your images by enlarging them
disproportionally.
The image and/or graphic captions should be written in Arial
20 and centered.
Image Quality Check Zoom in and look at your images at 100% magnification. If
they look good they will print well.
QUICK START (cont. )
Text size Adjust the size of your text based on how much content you
have to present.
The default template text offers a good starting point.
Graphs / Charts You can simply copy and paste charts and graphs from Excel
or Word. Some reformatting may be required depending on
how the original document has been created.
How to remove the info bars You can delete the info bars by going to VIEW > SLIDE
MASTER.
Save your work Save your poster as a PowerPoint document (.ppt/.pptx) and
send it to the EBMT Communication Coordinator:
THANK YOU!
At the ASH congress 2015 Neal Young presented promising results from the NIH
phase II study on Eltrombopag. Addition of Eltrombopag to immuno-
suppressive therapy markedly increases overall and complete hematologic
response rates in treatment-naive SAA.
See: bloodjournal.org/content/126/23/LBA-2.
The Race trial investigates Eltrombopag in a phase III randomised setting,
aiming to change standard practice in SAA. Purpose of the trial is to improve
the efficacy of the current treatment by combining standard
immunosuppression with Eltrombopag in order to rescue or improve the
function of residual hematopoiesis.
In Italy we obtained ethics approval in 3 sites; pending approval in 3 sites.
For sites with ethics approval we are negotiating site agreements. As soon as
approvals and contracts are finalised, we can formally open the site, ideally
within 2 weeks.
RACE Trial
EBMT Clinical Trials Office
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
1. Diagnosis of severe or very severe aplastic anemia, defined by:
• At least two of the following:
Absolute neutrophil counts <0,5 x 109/L (severe) or <0,2 x 109/L
(very severe)
Platelets counts <20 x 109/L
Reticulocyte counts <60 x 109/L
• Hypocellular bone marrow (<30% cellularity without evidences of fibrosis
or malignant cells)
2. Male or female age ≥ 15 years
Main Inclusion Criteria
Treatment schedule
Country Status
Country Approval Nr of sites Sites open
France NCA & EC 6 4
United Kingdom NCA & EC 5 2
Spain NCA & EC 5 0
Italy NCA & local EC 6 2
Netherlands NCA & EC 4 1
Germany submitting 5 0
Switzerland submitting 1 0
Total 32 9
Accrual
0
50
100
150
200
250
Pat
ien
ts in
clu
de
d
Date
Actual and Expected Accrual
Actual Accrual
Expectedaccrual sitesopen till June(exc. DE/CH/IT)
0
5
10
15
20
25
30
35
40
RACE Trial
Working party Principal investigators Trial Coordinator
SAA-WP
Antonio M Risitano
Regis Peffault De Latour Marleen van Os
To investigate whether Eltrombopag (Revolade, Novartis) added to
standard immunosuppressive treatment, CsA + hATG (ATGAM, Pfizer),
increases the rate of early complete response in untreated AA patients
Participating
countries
Primary Endpoint
Rate of Complete Response at 3 months
since start of treatment in untreated severe AA patients.
CR is defined as: Hb>10 g/dL, ANC>1,000/µL and Platelets>100,000 µL
Treatment Dose (units) Treatment Period
Arm A (standard):
ATGAM 40 mg/kg/day, iv Day 1, 2, 3 and 4
Cyclosporine A 5 mg/kg/day, po Day 1-365
Arm B: arm A +
Investigational drug Eltrombopag 150 mg every 24 h, po Day 14-90 (or 14-180)
NIH Phase II Study on Eltrombopag
EBMT
Executive Director
Andreu Gusi
Finance
Jürgen Kuball Liesbeth Hoekstra
Legal Consultant
Jeroen Knijpinga
CT Operations Manager
Alain Barrois
RACE Trial Manager
Marleen van Os
Trial Coordinator
Janette Zarev (pharmacovigilance)
Trial Coordinator
Annelies Kleijne (data management)
Trial Coordinator
Eline Smits (drug supply)
Trial Coordinator
Ruzena Uddin (regulatory)
Trial Coordinator
Sue Philpott (insurance / CTMS)
Statistician
Simona Iacobelli
SAA Working Party
Chair Carlo Dufour
Coordinating Investigator
Antonio Risitano
Coordinating Investigator
Régis Peffault De Latour
RACE Team
Contact: [email protected]