Originele protocol

Eligibility for registration

All patients must be registered before start of the second cycle of chemotherapy (either re-induction or first consolidation) and must meet all of the following eligibility criteria.

Inclusion criteria

  • Patients with poor-risk or very poor-risk AML or RAEB with IPSS ≥ 1.5 , (see appendix D).
    During the phase I part only very poor-risk patients will be included
  • Eligibility for continuation with intensive induction/consolidation chemotherapy
  • Eligible for allogeneic donor search (related/unrelated)
  • 18-70 years, inclusive
  • Negative serum pregnancy test for female patients of childbearing potential, at registration
  • Female patients of childbearing potential must use an effective contraceptive method during the study and for a minimum of 6 months after study treatment
  • Written informed consent

Exclusion criteria

  • History of active malignancy during the past 2 years with the exception of basal carcinoma of the skin or carcinoma “in situ” of the cervix or breast
  • Known HIV-positivity
  • Pregnant or breast-feeding female patients

Eligibility criteria for start of protocol treatment

Inclusion criteria

  • Poor-risk or very poor-risk AML or RAEB with IPSS ≥ 1.5.
    During the phase I part only very poor-risk patients will be included.
  • Responsive disease (< 10% blasts at 3 and/or 4 weeks after start of induction cycle II)
  • Recovery of mucositis after preceding chemotherapy
  • Absence of active opportunistic infections
  • Absence of active CNS localisation
  • HLA-compatible donor available (≥ 7/8 matched unrelated donor or fully matched sibling donor)
  • WHO-performance status 0-2
  • Written informed consent

Exclusion criteria

  • Severe cardiac dysfunction (NYHA classification III-IV, see appendix H)
  • Severe pulmonary dysfunction (CTCAE grade III-IV, see appendix G)
  • Severe neurological or psychiatric disease
  • Significant hepatic dysfunction (serum bilirubin or transaminases ≥ 5 times upper limit of normal)
  • Significant renal dysfunction (creatinine clearance < 30 ml/min after rehydration)
  • Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule
  • Concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes, infection, hypertension, cancer, etc.)