Maintenance lenalidomide in combination with 5-azacitidine as post-remission therapy for acute myeloid leukaemia.

摘要: In this Phase 1b study, the safety and tolerability of maintenance therapy, comprising lenalidomide (0-25 mg, days 5-25) in combination with azacitidine (50-75 mg/m(2) , 1-5) every 28 d, was explored 40 patients acute myeloid leukaemia (AML) complete remission after chemotherapy. Eligibility included AML first (CR1) adverse risk karyotype (n = 8), fms-related tyrosine kinase 3-internal tandem duplication (FLT3-ITD) 5), age ≥60 years 31) or second (CR2) 14). Dose-limiting toxicity not reached. Common toxicities were haematological, infection, injection pain, constipation, fatigue diarrhoea. CR1, median relapse-free (RFS) overall survival (OS) 12 20 months, respectively. CR2, RFS 11 OS yet Among 29 intermediate cytogenetic risk, 50% at 24 months. There five concomitant FLT3-ITD nucleophosmin (NPM1) mutation; none have relapsed all are still alive 17-39 Maintenance lenalidomide/azacitidine augmented function cytotoxic T lymphocytes, particularly NPM1 mutation. The effective suppressing residual DNA (cytosine-5-)-methyltransferase 3 alpha (DNMT3A)-positive disease, resulting sustained concurrent Azacitidine/lenalidomide as therapy for high-risk warrants further exploration.