High-dose cytarabin versus low-dose cytarabin plus interferon-alpha-2a both followed by maintenance with interferon-alpha-2a in chronic myeloid leukemia

INTERVENTION: Induction therapy with hydroxyurea (3 ‐ 4 weeks). Patients less than or equal to 55 years with a HLA identical sibling proceed to allo‐BMT. All other patients are randomised between: Arm A: Cycle I: cytarabin/idarubicin, Cycle II: high‐dose cytarabin; maintenance with interferon‐alpha‐2a Arm B: Low‐dose cytarabin and interferon‐alpha‐2a; maintenance with interferon‐alpha‐2a CONDITION: Chronic myeloid leukemia (CML) ; Cancer ; Myeloid leukaemia PRIMARY OUTCOME: Event‐free survival SECONDARY OUTCOME: 1. Haematological and cytogenetical remission; 2. Overall survival; 3. Remission duration INCLUSION CRITERIA: 1. Newly diagnosed patients with chronic myeloid leukemia (CML) in first chronic phase less than or equal to 6 months 2. Presence of Philadelphia chromosome or BCR/ABL rearrangement 3. Age 16 ‐ 65 years inclusive 4. World Health Organisation (WHO) performance scale less than or equal to 2