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Leuk Res Rep. 2013 Aug 28;2(2):70-4. doi: 10.1016/j.lrr.2013.07.003. eCollection 2013.

Lenalidomide monotherapy and in combination with cytarabine, daunorubicin and etoposide for high-risk myelodysplasia and acute myeloid leukaemia with chromosome 5 abnormalities.

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Christie Hospital, Manchester, United Kingdom.
Aberdeen Royal Infirmary, Aberdeen, United Kingdom.
John Radcliffe Hospital, Oxford, United Kingdom.
Western General Hospital, Edinburgh, United Kingdom.
Nottingham University Hospital, Nottingham, United Kingdom.
St. Bartholomew's Hospital, London, United Kingdom.
Clinical Trials Research Unit, University of Leeds, Leeds, United Kingdom.
St. James's Institute of Oncology, Leeds, United Kingdom.


Patients with high risk myelodysplasia (HR-MDS) and acute myeloid leukaemia (AML) with chromosomal changes involving deletion of the long arm of chromosome 5 (del5q), especially with complex karyotype, rarely have a durable response to combination chemotherapy. In the subgroup with monosomal karyotype there are no long term survivors (Fang et al., 2011) [1]. Recent experience indicates that the incidence of del5q in AML is ~20-30%, with only 20-25% of patients achieving complete remission (CR) (Farag et al., 2006) [2]. Additionally, therapy has significant toxicity, with induction death rates ~20% even in younger patients (Juliusson et al., 2009) [3]. This lack of efficacy provides the clinical rationale for combination/sequential therapy with Lenalidomide and combination chemotherapy. Dose dependent haematological toxicity is the major safety concern with such a combination protocol. Therefore we conducted a phase 2 study, AML Len5 (ISRCTN58492795), to assess safety, tolerability and efficacy of lenalidomide monotherapy, followed by lenalidomide with intensive chemotherapy in patients with primary/relapsed/refractory high risk MDS or AML with abnormalities of chromosome 5.


Acute myeloid leukaemia; Chemotherapy; Chromosome 5; Lenalidomide; Myelodysplasia

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