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