Five women and one man at age of 44 to 70 with relapsed or refractory Ph-positive ALL were treated within multicentre study of extended access CZSTI5710114 with imatinib (Glivec®, STI 571) at the dose 600mg daily. 3 patients achieved complete and 2 partial haematologic response with median duration of 157 days. The death was caused by relapse of disease despite continuing treatment with imatinib in four of five patients who died. The patient who was treated because of relapse after allogeneic stem cell transplantation achieved molecular genetic remission. In addition, 18 men and 14 women with accelerated phase of CML at age 18 to 72 years were treated with the same dose of imatinib. Patients were followed-up for 454 days in median (41–597). Haematologic response (complete in 11 (34 %) and partial in 18 (56 %) patients) was achieved in median of 28 days. In 3 (9 %) patients reinstitution of chronic phase of disease was achieved only. 23 patients were assessed for cytogenetic response – 13 (57 %) achieved major (8 of them complete) response. Imatinib at dose of 600 mg daily has lead to hematologic toxicity of 3rd and 4th grade according NCI/NIH scale in three quarters of patients that caused interruption of therapy in 19 and reduction of dose in 18 patients. Non-haematologic toxicity was not serious and was easily managed with symptomatic therapy. Progression occurred in 9 (28 %) patients and 10 (31 %) patients died during the follow-up. The statistic analysis has confirmed that the probability of achievement of haematologic remission together with the risk of disease progression could be connected with parameters associated with tumour load at the beginning of treatment – WBC, splenomegaly and presence of blasts in peripheral blood. The probability of achievement of significant cytogenetic response was significantly higher in younger patients with shorter duration of CML and with lower initial platelet count. The probability of overall survival of patients was significantly influenced by the achievement of hematologic and cytogenetic remission. At present time, imatinib represents the most powerful drug for conservative therapy of CML. Our experience confirms its high response rate also in patients with accelerated phase of CML. Efficacy of imatinib treatment has been increased with shorter duration and less advanced disease.

        Key words: chronic myelogenous leukaemia, acute lymphoblastic leukaemia, imatinib, Glivec, STI 571, Ph chromosome, BCR/ABL, tyrosine kinase