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.)
