Another step forward has been made toward the enrollment of new patients in the DEEP-2 study, a phase III multicentre, randomised, open label, non-inferiority active-controlled trial aiming at comparing for the first time the efficacy of deferiprone (DFP) vs deferasirox (DFX) in paediatric patients affected by hereditary haemoglobinopaties requiring chronic transfusions and chelation.
The DEEP-2 study actually involves a total of 227 patients included in 32 recruiting centres: Italy (51), Egypt (123), Greece (9), Albania (25) Tunisia (7) and UK (10). The first nine patients have been enrolled in UK and 10 in Tunisia this week. The enrollment will terminate when 344 patients will have been randomized.
Further 5 new centres in Turkey (Hacettepe University, Faculty of Medicine in Ankara; Istanbul University, Cerrahpaşa Faculty of Medicine in Istanbul; Kanuni Sultan Suleyman TRH in Istanbul; Mersin University Faculty of Medicine in Mersin; Akdeniz University Medical Faculty in Antalya), 1 in Lebanon (Nini Hospital in Tripoli), 1 in Albania (Hospital ‘Ihsan Çabej’ in Lushnjë) and 1 in Qatar (National Center for Cancer Care and Research in Doha) have been contracted and are very close to recruit their first patients. The centers in Cyprus and Morocco are waiting for the last authorization before they can be activated.
In order to ensure the correct implementation of study protocol and speed up the recruitment phase, the DEEP Management Team has issued a new version (2.0) of the Study Procedure Manual both in PDF format and hard copy to be sent to each site. This version is specifically addressed to the clinical investigators aiming at facilitating consistency with protocol implementation among study sites and to be an on hand reference to solve doubts/questions that may arise during the study conduction.
Moreover, all PIs regularly receive a monthly DEEP-2 study newsletter with an update of the patients’ enrolment and the FAQ section, available on the website, aimed at clarifying most of the criticisms of the study protocol.