After the sad decision to cancel the General Assembly Meeting in Tunis, due to the disorders which have occurred across the country, the 7th DEEP General Assembly (GA) will take place in Padua (Italy) on April 13th -15th, 2016 with the participation of the whole DEEP Consortium as well as of external experts.

Here you can find the final agenda of the Meeting, which can be browsed even through mobile devices.

The meeting will be focused on a general update of the project’s activities, the progresses and achievements of the DEEP project as well as the finalization of the DEEP-2 and DEEP-3 studies, that are of utmost priority. Among others, the financial resources reallocation according to the recruitment performance at any involved centre will be discussed during the meeting.

In the same context of the GA meeting, the DEEP-2 Investigator Meeting and the 4th Open Meeting will take place.

In particular, the Scientific Open Meeting on April 15th, 2016 will entail two sessions:

   –  Challenges And Opportunities Of Conducting Clinical Trials In Paediatrics

   –  Management Of Thalassaemia And Haemoglobinopathies: An Ongoing Challenge

The Scientific Open Meeting will be the occasion to raise the attention on the progresses achieved by the clinical research and the challenges to be faced in conducting clinical trials in paediatrics, also highlighting the importance of the international cooperation through European Networks and the global initiatives to create synergies and foster clinical research. The second session will be more focused on the new pathways and therapeutic strategies for the management of thalassaemia and haemoglobinopathies and will also be the occasion to talk about the goals of the DEEP project.

More details on the event and the final agenda are available here and through our social network channels (Facebook and Google+).

What is the progress of the study that is to date in the last collection rush for most of the centres involved and which are its main progresses and achievements? We talked about them with Assoc. Prof. Antje Neubert from Universitätsklinikum Erlangen (UKER).

“The study has recently successfully received the ethical approval for two new centres in Casablanca (Hôpital 20 août and Hôpital Universitaire d’enfants Abderrahim Harrouchi) and the recruitment started at Centre National de Greffe de Moelle Osseuse (CNGMO) of Tunis. To date we have enrolled 301 paediatric patients (92% of 328 patients) from 16 centres in 6 different countries. All centres put huge efforts into the data collection. This data are sufficient to provide a comprehensive safety profile of deferiprone treatment in children and adolescents within our defined sample size and set confidence interval.”

With reference to how the long-term study results will increase deferiprone post-marketing evidence, Prof. Neubert pointed out that “the latest product information of deferiprone states that insufficient data on safety and efficacy in children below 10 years of age are available at the moment. The results of the long-term observational safety study DEEP-3 will close this gap and provide valuable safety data for the treatment of transfusional iron overload in children and adolescents with beta-thalassaemia major“. She also explained that adverse reactions will be more predictable and monitoring for known adverse reactions in children will make the treatment safer in general.

Considering that the prospective arm of the study has been concluded in October 2015, while retrospective data will be collected until termination of the study with reference to the same period (up to October 2015), she further clarified that “data collection is still on-going, but in 286 patients we already have the complete data set. Our participating investigators are doing their best collating all the requested clinical data. Nearly 60% of our enrolled patients started deferiprone treatment before the age of 10 years. This gives us good confidence that the generated safety data adds to the existing data from other clinical trials and observational studies. So far we collected about 423 adverse events which may or may not be related to deferiprone therapy. Of those, our adverse reaction assessment team already evaluated 134 events including 49 serious adverse events. The team found that 42 adverse reactions and 20 serious adverse reactions related to deferiprone treatment were found. These reactions  – she continued – comprise elevated liver enzymes, arthropathy and mild to moderate neutropenia. However, these are only very early results and we need to wait for the final results before drawing any conclusions about the safety profile of deferiprone in children.”

On October 2015, 283 patients (86% of 328 subjects of the study population) were enrolled, 36 of which are currently in the prospective phase of the study. The observation, which aims to investigate serious and non-serious adverse reactions, as well as risk factors for ADRs related to deferiprone treatment, has ended for 166 patients. The mean observation time per patient was currently 2.1 years, with 595 person-years (84% of 711 person-years).

To date, the study is in the last collection episode for most of the centres involved (Tirana, Nicosia, Bari, Naples, Padua, Palermo and Florence) that will be closed for recruitment soon. The prospective arm of the study will be concluded in October 2015, while retrospective data will be collected until termination of the study with reference to the same period (up to October 2015).

Recently the study successfully received the ethical approval for two new centres in Casablanca (Hôpital 20 août and Hôpital Universitaire d’enfants Abderrahim Harrouchi) and the recruitment started at Centre National de Greffe de Moelle Osseuse (CNGMO) of Tunis.

Furthermore, the DEEP-3 Study Team is currently in the process of including two new centres in Egypt: Alexandria and Zagazig.