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Mid-term report 2013 - The European LeukemiaNet

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<strong>European</strong> <strong>LeukemiaNet</strong> <strong>Mid</strong><strong>term</strong> Report, 08-RNP-071<br />

demographic paper which will include the impact of the new IPSS-R.<br />

2) <strong>The</strong> fifth international ELN workshop of FCM in MDS,Amsterdam, Netherlands<br />

October 26‐27, 2012<br />

3) Progress of the Trial Platform: EMSCO and planned trial(s)<br />

<strong>The</strong> ELN-based MDS clinical trial coordinating office (EMSCO) has been established in<br />

Dresden. <strong>The</strong> first trial in France and Germany is expected to start before the end of <strong>2013</strong>.<br />

4) ELN diagnostic and therapeutic guidelines and new plans, including specific guidelines for<br />

allogeneic SCT in MDS<br />

<strong>The</strong> manuscript has been submitted to Blood and it is under revision after having received<br />

the comments of the reviewers.<br />

2.1.9. WP9 (MPD):<br />

Projects:<br />

Clinically relevant end-points in contemporary trials for Ph-neg classical MPNs: A joint project<br />

of the ELN and IWG-MRT Groups<br />

<strong>The</strong> rationale of this project is that the selection of best variables for measuring benefits<br />

or harms of new interventions in Philadelphia negative classic MPNs is a complex and<br />

open to debate task. <strong>The</strong>re is a major need to develop clearly defined endpoints to<br />

support claims of efficacy of therapies for MPNs. <strong>The</strong>se endpoints need to be developed<br />

and utilized by investigators leading clinical trials in MPNs. <strong>The</strong> goal of this project is to<br />

provide guidance in the definition of clinically relevant end-points that can expedite new<br />

drug approvals for MPNs in the appropriate trial design settings.<br />

Registries:<br />

A new registry of patients with MPD and splanchnic vein thrombosis (Budd-Chiari syndrome,<br />

portal or mesenteric vein thrombosis) has been launched in <strong>2013</strong>.<br />

A new project was presented in <strong>2013</strong> and was opened in May <strong>2013</strong> to collect the cases of<br />

cerebral venous thrombosis in patients with MPD.<br />

<strong>The</strong> registry of pregnancies in patients with MPD was closed for inclusions in <strong>2013</strong>? And the<br />

analysis for a final <strong>report</strong> and publication is ongoing.<br />

A MPN&MPNr-EuroNet registry is in planning.<br />

Recommendations:<br />

Several recommendations have been released on behalf of the ELN, as described in the<br />

appendix 7.5.1.<br />

<strong>The</strong> leading project for recommendation in <strong>2013</strong> is the definition of resistance and<br />

intolerance to ruxolitinib.<br />

Another consensus conference is ongoing in <strong>2013</strong> to define and harmonize<br />

histomorphological response criteria to JAK inhibitors. Two face-to-face meetings have been<br />

organized and the redaction of the final consensus is in progress, with a publication planed<br />

for Q3 <strong>2013</strong>.<br />

2.1.10. WP10 (Diagnostics):<br />

WP10 aims at pursuing the exploration of the best methods for diagnosis and MRD detection<br />

in morphology and flow cytometry.<br />

<strong>The</strong> morphology faculty, driven by Pr Gina Zini, still works at implementing the atlas of bone<br />

marrow cells morphology, accessible on the ELN Website.<br />

In flow, recommendations about accreditation of the flow cytometry laboratory are in<br />

progress. Part of this will soon be in press in Cytometry Part B, as the result of an<br />

international workshop where WP10 members participated. Guidelines have been issued in<br />

France and discussed in Mannheim in February. <strong>The</strong> February <strong>2013</strong> annual meeting of the<br />

8

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