Treatment of Patients With Myelodysplastic Syndrome or Acute Myelocytic Leukemia With an Impending Hematological Relapse With Azacitidine (Vidaza)

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.