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Clin Lymphoma Myeloma Leuk. 2012 Oct;12(5):341-4. doi: 10.1016/j.clml.2012.04.001. Epub 2012 May 10.

A phase II study of lenalidomide alone in relapsed/refractory acute myeloid leukemia or high-risk myelodysplastic syndromes with chromosome 5 abnormalities.

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Department of Leukemia, University of Texas M.D. Anderson Cancer Center, Houston, TX 77030, USA.


This phase II study assessed the efficacy and safety of lenalidomide in patients with relapsed/refractory acute myeloid leukemia (N = 18) and high-risk myelodysplastic syndrome (N = 9) with chromosome 5 abnormalities. The overall complete remission rate with or without platelet recovery was 7% (2/27). Activity of lenalidomide was limited to patients with noncomplex cytogenetics.


Lenalidomide is effective in low-risk myelodysplastic syndromes (MDS) with deletion 5q. We conducted a phase II study to evaluate the safety and efficacy of lenalidomide in patients with relapsed/refractory acute myeloid leukemia (AML) and high-risk MDS with any chromosome 5 abnormality.


Eighteen adults with AML and 9 with high-risk MDS were enrolled. Lenalidomide was given orally at doses 5 to 25 mg daily for 21 days of a 28-day cycle until disease progression or unacceptable adverse event.


Median age for all 27 patients was 64 years (range, 39-88 years) with a median of 2 previous therapies (range, 1-6 lines). Two patients (7%) with AML and 5q deletion and +8 cytogenetic abnormality in 2 separate clones achieved complete remission (CR) or CR without platelet recovery (CRp). Response durations were 4 and 6 months, respectively. No responses were seen in patients with chromosome 5 abnormality in a complex cytogenetic background. Twenty patients (74%) developed neutropenic fever or infection requiring hospitalization.


Clinical activity of lenalidomide as single agent in AML and high-risk MDS with chromosome 5 abnormalities appears to be limited to patients with noncomplex cytogenetics.

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