Treatment of Imminent Haematological Relapse in Patients With AML and MDS Following Allogeneic Stem Cell Transplantation With 5-azacitidine (Vidaza®)

Inclusion Criteria: Screening phase:

• Age > 18 years

• Patients with CD34+ AML or MDS post-allogeneic HSCT

• Written patient consent after consultation Treatment phase

• AML/MDS: donor chimerism < 80% in the CD34+ subpopulation following allogeneic HSCT inpatients with CD34+ AML or MDS, but with no haematological relapse (blasts < 5% inbone marrow)

• Leukocytes > 3 Gpt/l and platelets > 75 Gpt/l (transfusion-independent)

Exclusion Criteria:

• Known intolerance to 5-azacitidine or mannitol

• Uncontrollable infectious disease

• Patients with active hepatitis B or C or HIV infection

• Severe hepatic function impairment (ASAT and ALAT may not be above three times thenormal value) or hepatic cirrhosis, or malignant hepatic tumour

• Renal function impairment (creatinine > twice the normal value, creatinine clearance < 50 ml/min)

• Pregnancy or lactation

• Women of childbearing age, except for those who meet the following criteria:

• postmenopausal (12 months natural amenorrhoea)

• postoperative (6 weeks after bilateral ovarectomy with or without hysterectomy)

• regular and correct use of a contraceptive method with an error rate < 1% per year (e.g. implants, depot injections, combined oral contraceptives, intrauterine device -IUD, whereby hormonal coils with a Pearl Index of < 1% are safer than copper coils)

• sexual abstinence

• Partner vasectomy

• Men who do not use one of the following for contraception:

• sexual abstinence

• post vasectomy

• condoms

• Participation of the patient in a drug trial outside the indication of allogeneictransplantation up to four weeks before study initiation

• Addictive or other illnesses that prevent the person concerned from comprehending thenature and impact, as well as potentical consequences of the clinical trial

• Evidence that the patient may intentionally not comply with the protocol, e.g. lack ofcooperation With the exception of a known allergic reaction or intolerance to 5-azacitidine, these criteria do not apply to the screening phase.