Treatment of Patients With Myelodysplastic Syndrome or Acute Myelocytic Leukemia With an Impending Hematological Relapse With Azacitidin (Vidaza) (RELAZA2)

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(8,21), inv16, t(6,9), NPM1 pos. or CD34+ 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+ MDS or AML or
• increase in the AML-specific molecular marker in the quantitative PCR for t(8,21), inv16, 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 bilateral ovariectomy with or without hysterectomy)
  • regular and proper use of a contraceptive method with error rate <1% per year (e.g., implants, depot injections, oral contraceptives, intrauterine device, IUD)
  • sexual abstinence
  • Vasectomy of the partner

• Men who do not use one of the following types of contraception for a period of 3 months 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.