Phase I/ II II study on cytarabine and idarubicin combined with escalating doses of clofarabine in newly diagnosed patients with acute myeloid leukaemia and high risk for induction failure ( AMLSG AMLSG 17‐10 CIARA CIARA trial)

摘要

Summary This open‐label, multicentre phase I/ II study determined the maximum tolerated dose ( MTD ), safety and efficacy of clofarabine administered with cytarabine and idarubicin in newly diagnosed acute myeloid leukaemia ( AML ) patients lacking favourable genetic aberrations. The MTD was 30?mg/m 2 clofarabine for patients below and above 60?years. The most frequently reported grade 3–4 non‐haematological adverse events were infectious and gastrointestinal toxicities. Complete remission ( CR )/ CR with incomplete recovery rate was 67%. Allogeneic haematopoietic cell transplantation in first remission was feasible in a high proportion of younger AML patients and probably contributed to the favourable outcome compared to historical controls.