Clinical trial NCT00352001 (phase 1/phase 2, status: completed)
Conditions: leukemia, myelodysplastic syndromes
ICD codes: C95.91, C95.92, Z80.6, Z85.6, C90.11, C90.12, C91.01, D46.9, D46.C, D46.Z
Drugs: azacitidine, lenalidomide
SMILES: NC1=CC=CC2=C1CN(C1CCC(=O)NC1=O)C2=O, NC1=CC=CC2=C1CN(C1CCC(=O)NC1=O)C2=O
Eligibility criteria:

        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