Clinical trial NCT00043134 (phase 3, status: unknown status)
Conditions: leukemia, myelodysplastic syndromes, myelodysplastic/myeloproliferative neoplasms
ICD codes: C95.91, C95.92, Z80.6, Z85.6, C90.11, C90.12, C91.01, D46.9, D46.C, D46.Z, C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2
Drugs: decitabine
SMILES: CN(C)\N=N\C1=C(N=CN1)C(N)=O
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Diagnosis of primary or secondary myelodysplastic syndromes (MDS)

               -  Any FAB or WHO criteria cellular type allowed

          -  Bone marrow blast count on aspiration or biopsy of 1 of the following:

               -  No more than 10% with poor cytogenetic risk factors (defined as any numerical or
                  structural abnormality of chromosome 7 and/or complex abnormalities)

               -  11-20%

               -  21-30% for patients with acute myeloid leukemia (AML) secondary to MDS (i.e.,
                  refractory anemia with excess blasts in transformation by FAB classification)

               -  Patients who failed the cytogenetic exam are allowed provided bone marrow blasts
                  are at least 5% and/or 2-3 cytopenias are present

          -  No rapid progression towards full-blown AML

          -  No blast crisis of chronic myeloid leukemia

          -  No t(8;21) alone or in combination with other abnormalities

          -  Ineligible for intensive chemotherapy (e.g., cytarabine or an anthracycline)

        PATIENT CHARACTERISTICS:

        Age

          -  60 and over

        Performance status

          -  WHO 0-2

        Life expectancy

          -  Not specified

        Hematopoietic

          -  See Disease Characteristics

        Hepatic

          -  Bilirubin less than 1.5 times upper limit of normal (ULN)

          -  Hepatitis B surface antigen negative

        Renal

          -  Creatinine less than 1.5 times ULN

        Cardiovascular

          -  No severe cardiovascular disease

          -  No arrhythmias requiring chronic treatment

          -  No congestive heart failure

          -  No New York Heart Association class III or IV heart disease

          -  No symptomatic ischemic heart disease

        Other

          -  HIV negative

          -  No active uncontrolled infection

          -  No other malignancy within the past 3 years except basal cell or squamous cell skin
             cancer or carcinoma in situ of the cervix within the past 2 years

          -  No prior or concurrent evidence of CNS or psychiatric disorders requiring
             hospitalization

          -  No psychological, familial, sociological, or geographical condition that would
             preclude study

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  More than 6 weeks since prior growth factors for primary MDS

          -  No concurrent antiangiogenic drugs (e.g., thalidomide)

          -  No concurrent interleukin, interferon, or anti-thymocyte globulin

        Chemotherapy

          -  See Disease Characteristics

          -  More than 6 weeks since prior hydroxyurea for primary MDS

          -  No other prior chemotherapy for MDS or AML

          -  Prior chemotherapy for solid tumors or lymphoma (resulting in secondary MDS) allowed

        Endocrine therapy

          -  No concurrent steroids (except as inhalation therapy)

        Radiotherapy

          -  Prior radiotherapy for solid tumors or lymphoma (resulting in secondary MDS) allowed

        Surgery

          -  Not specified

        Other

          -  More than 6 weeks since prior immunosuppressive agents for primary MDS

          -  No concurrent amifostine

          -  No concurrent cyclosporine

          -  No other concurrent experimental therapies