Induction, Consolidation and Intensification Therapy for Patients Younger Than 66 Years With Previously Untreated CD33 Positive Acute Myeloid Leukemia (AML)
- Age 18-65 years.
- WHO PS grade 0-2 (Appendix B) or Karnofsky > 70.
- AML according to the new WHO criteria, i.e., % of BM blasts ≥ 20%. NB. this % should
be assessed on a BM aspiration or on a BM biopsy
- All FAB subtypes except M3.
- CD33 positivity (> 20%). It is mandatory to perform an immunotyping of the BM blasts
in particular the determination of CD33 positivity, which will be used as a inclusion
- Previously untreated (except ≤ 14 days of Hydroxyurea) primary or secondary AML
(including AML after MDS).
- Adequate renal and liver function, i.e., creatinine < 2 mg/dl and bilirubin, ALT/AST
≤ 3 times the upper limit of normal.
- Written informed consent
- Blast crisis of chronic myeloid leukemia.
- AML supervening after other myeloproliferative diseases.
- AML de novo or secondary previously pretreated.
- Concomitant malignant disease.
- Active central nervous system (CNS) leukemia.
- Active uncontrolled infection [NB severe systemic infection should be excluded].
- Concomitant severe cardiovascular disease, i.e., arrhythmias requiring chronic
treatment, congestive heart failure or symptomatic ischemic heart disease.
- Cardiac ejection fraction of 50% or less.
- Severe pulmonary dysfunction (CTC grade 3-4).
- Severe concomitant neurological or psychiatric disease.
- History of alcohol abuse.
- HIV positivity.
- Man and woman not agreeing to the adequate contraceptive precautions during study
period and for at last 24 months after stop of therapy.
- Any psychological, familiar, sociological or geographical condition potentially
hampering compliance with the study protocol and follow-up schedule.