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Acute promyelocytic leukaemia (APL) is characterised by the morphology of bias cells (M3), t(15;17) translocation, and coagulopathy combining disseminated intravascular coagulation (DIC) and fibrinolysis. Anthracy cline-cytosine arabinoside (Ara C) intensive chemotherapy yields a complete remission in 50 percent (%) to 80% of newly diagnosed APL patients. Failure to achieve complete remission results in fatal bleeding due to coagulopathy or fatal sepsis during the phase of aplasia. It has been recently shown that all trans retinoic acid (ATRA) selectively differentiates abnormal promyelocytes into mature granulocytes in APL, both in vitro and in vivo, and induced complete remission in 80% to 90% of the newly diagnosed patients. It has also been observed that therapy with ATRA rapidly improved coagulopathy, and induced no aplasia. However, in 30% of patients the treatment with ATRA as a single drug was associated with rapid increase in leukocytes and signs of "ATRA syndrome", which could have fatal outcome. Therefore the European study group initiated in 1991 a multicentre randomised trial comparing chemotherapy with daunorubicin Ara C (chemotherapy group) and ATRA combined to the same chemotherapy (ATRA group) in newly diagnosed APL patients, aged 65 years or less. Results of this study strongly suggest that ATRA should be incorporated in the front line therapy of newly diagnosed APL. The aim of our study was to confirm their results in our newly diagnosed patients. ⋯ Our clinical trial shows for the first time in our county a beneficial effect of ATRA in addition to chemotherapy compared with chemotherapy alone in newly diagnosed APL, thus comfirming the results of the European study group. The only flaw of in our study may come from the fact that the patients included in the study were not randomised and that for the comparison of the ATRA group were used previously treated patients with chemotherapy alone. However, we believe that this flaw has been overcome since uniform diagnostic procedure and particularly MIC classification were performed in all patients. In addition to that, all patients included in the trial were subjected to the analysis of haemostatic status as well as to precise biochemical studies, ECG and abdominal echography. It is interesting to note that in our study, similarity to the European study group, 13% of patients developed "ATRA syndrome". Therefore, it is recommended that further effort should be made in order to prevent this fatal and not yet resolved syndrome.