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Leuk Lymphoma. 2016;57(3):609-15. doi: 10.3109/10428194.2015.1091930. Epub 2015 Oct 13.

Sequential azacitidine plus lenalidomide in previously treated elderly patients with acute myeloid leukemia and higher risk myelodysplastic syndrome.

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a Division of Hematology, Department of Medicine , Stanford University School of Medicine , Stanford , CA , USA .
b Division of Hematologic Malignancies, Department of Medical Oncology , Dana-Farber Cancer Institute , Boston , MA , USA .
c Eutropics Pharmaceuticals , Cambridge , MA , USA , and.
d Department of Health Research and Policy , Stanford University School of Medicine , Stanford , CA , USA.


The outcome of sequential azacitidine with lenalidomide has not been reported in previously treated patients with acute myeloid leukemia (AML) and higher risk myelodysplastic syndrome (MDS). This study describes a phase 2 study evaluating the safety and efficacy of this combination in elderly patients with AML and MDS with prior hypomethylating agent (HMA) and/or immunomodulatory agent exposure. Patients were treated on a 42-day cycle with azacitidine at 75 mg/m2 SQ/IV daily on days 1-7, followed by lenalidomide 50 mg orally daily on days 8-28. The median number of treatment cycles on study was two (range = 1-11). Of 32 evaluable patients, the overall response rate was 25%. Neutropenic fever was the most common serious adverse event, but overall the combination was well-tolerated. The median overall survival (OS) for responders vs non-responders was 9.8 vs 4.0 months, respectively (HR = 0.36, p = 0.016). In conclusion, this combination demonstrated modest clinical activity in this poor risk population.


AML; Hypomethylating agent failure; MDS; azacitidine; azanucleosides; lenalidomide

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