treatment of patients with myelodysplastic syndrome or acute myelocytic leukemia with an impending hematological relapse with azacitidine (vidaza)

Conditions: Acute Myelocytic Leukemia; Myelodysplastic Syndrome

Summary: assessment of efficacy of azacitidine to prevent a relapse

analysis of the effectiveness of azacitidine 6 months after start of therapy to prevent a hematological relapse in mds or aml patients with significant residuals or an increase of minimal residual disease (mrd) which is defined as: * decrease of cd34 donor chimerism (\<80%) after allogeneic related or unrelated hsct in cd34+ or cd117+ mds or aml or * increase in the aml-specific molecular markers in the quantitative pcr for t(6,9), npm1+ aml \>1% (ratio to reference gene) after conventional chemotherapy or allogeneic hsct or * persistence of the (above) mrd level \>1% after conventional chemotherapy or allogeneic hsct * tolerance of azacitidine * quality of the response of the mrd (major vs. minor) and the relapse-free survival and overall survival 12, 24 and 30 months after starting treatment with azacitidine * modulation of cd34+, nk- and t-cells of mds and aml patients by azacitidine

Eligibility criteria:
inclusion criteria: screening: * signed informed consent * age ≥18 years * patients with mds or aml after conventional chemotherapy or allogeneic hsct and positive molecular marker such as t(6,9), npm1 pos. or cd34+ or cd117+ in the case of an allogeneic hsct treatment: * mds or aml without haematological relapse (blasts \<5% in the bone marrow), and * decrease of cd34 donor chimerism (\<80%) after allogeneic related or unrelated hsct in cd34+ or cd117+ mds or aml or * increase in the aml-specific molecular marker in the quantitative pcr for t(6,9), npm1+ aml \>1% after conventional chemotherapy or allogeneic hsct or * persistence of the (above) mrd levels \>1% (relative to the reference gene) after conventional chemotherapy or allogeneic hsct * leukocytes \> 3 gpt/l and platelets \>75 gpt/l (transfusion independent) exclusion criteria: * known history of hypersensitivity to any of the drugs used or their constituents or to drugs with similar chemical structure, * participation of the patient in another clinical trial within the last 4 weeks before the inclusion * addiction or other disorders that do not allow the concerned person, to assess the nature and scope and possible consequences in the clinical investigation * pregnant or breast feeding women * women of childbearing potential, except women who meet the following criteria: * post-menopausal (12 months natural amenorrhea or 6 months amenorrhea with serum fsh \>40 u/ml) * postoperative (6 weeks after hysterectomy with or without bilateral ovariectomy ) * regular and proper use of a contraceptive method with error rate \<1% per year (e.g., implants, depot injections, oral contraceptives, intrauterine device, iud) during study treatment and up to 1 year after completion of therapy * sexual abstinence during study treatment and up to 1 year after completion of therapy * vasectomy of the partner * men who do not use one of the following types of effective contraception during study treatment and up to 1 year after completion of therapy: * sexual abstinence * state post-vasectomy * condom * evidence that the participating person is not expected to comply with the protocol (such as lack of cooperation) * uncontrolled active infection * severe hepatic impairment (ast and alt may not exceed three times the normal) or liver cirrhosis or malignant liver tumor * dialysis dependent renal dysfunction * known severe congestive heart failure, incidence of clinically unstable cardiac or pulmonary disease these criteria are not for the screening phase up to a known allergic reaction to azacitidine or intolerance to apply.

Keywords: neoplasms benign, malignant and unspecified acute myeloid leukemia aml myelodysplastic syndrome mds