Lenalidomide and Azacitidine in Treating Patients With Advanced Myelodysplastic Syndromes

DISEASE CHARACTERISTICS:

• Diagnosis of myelodysplastic syndromes (MDS) meeting one of the following criteria:
• French-American-British histological classification criteria
• Refractory anemia with excess blasts (RAEB), defined as 5-19% myeloblasts in the bone marrow
• Patients with 20% blasts are considered to have acute myeloid leukemia (per WHO classification system) and are therefore excluded in this study
• Chronic myelomonocytic leukemia (CMML), defined as 10-19% myeloblasts in the bone marrow and/or 5-19% blasts in the blood
• WHO histological classification criteria
• RAEB-1, defined as 5-9% myeloblasts in the bone marrow
• RAEB-2, defined as 10-19% myeloblasts in the bone marrow and/or 5-19% blasts in the blood
• CMML-2, defined as 10-19% myeloblasts in the bone marrow and/or 5-19% blasts in the blood
• International Prognostic Scoring System (IPSS) score of intermediate 2 (1.5-2.0 points based on karyotype, cytopenias, and bone marrow blast percentage) or high (≥ 2.5 points), in the setting of ≥ 5% myeloblasts
• Considered ineligible for bone marrow transplantation as first-line therapy

PATIENT CHARACTERISTICS:

• Life expectancy ≥ 3 months
• ECOG performance status 0-2
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective double-method contraception for 4 weeks before, during, and for 4 weeks after completion of study treatment
• No serious medical condition, laboratory abnormality, or psychiatric illness that, in the opinion of the treating physician, would preclude study participation or preclude giving informed consent
• No preexisting neurotoxicity or neuropathy ≥ grade 2
• No rash or prior hypersensitivity or allergic reaction ≥ grade 3 to thalidomide
• Creatinine ≤ 2.0 mg/dL
• AST and ALT ≤ 2.0 times upper limit of normal
• Bilirubin ≤ 2 mg/dL
• Platelet count ≥ 50,000/mm^3
• Absolute neutrophil count ≥ 500/mm^3
• No other malignancy within the past 3 years except curatively treated carcinoma in situ of the cervix or nonmelanoma skin cancer
• No history of thromboembolic event or other condition requiring use of anticoagulation with warfarin or low molecular-weight heparin
• No known or suspected hypersensitivity to azacitidine or mannitol

PRIOR CONCURRENT THERAPY:

• More than 28 days since prior and no other concurrent investigational agents for MDS
• More than 28 days since prior approved therapy for MDS
• More than 14 days since prior growth factors
• More than 28 days since prior and no concurrent supraphysiologic doses (equivalent to > 10 mg/day of prednisone) of corticosteroids
• More than 12 months since prior radiotherapy, chemotherapy, or cytotoxic therapy for treatment of conditions other than MDS
• No prior lenalidomide or azacitidine
• No prior stem cell or bone marrow transplantation
• No concurrent androgens, epoetin alfa, or chemotherapy for MDS