Risk adapted treatment of acute myelocytic leukemia (AML).

First randomization:

1. Patients with newly diagnosed de novo AML (including all cytological subtypes M0-M7);

2. Age 15-60 yrs inclusive;

3. Patients have given informed consent;

4. Leucocytosis (WBC >30 x 109/l) is not an exclusion criterium, but it will require postponement of G-CSF administration until WBC have declined to 20 x 10^9/l on chemotherapy.





Patients after completion of CYCLE II and peripheral blood stem cell collection are eligible for second randomization if:

5. Complete remission continues (marrow cytology and blood evaluation);

6. Poor risk status according to criteria of Appendix III;

7. Not eligible for genotypically HLA matched allogeneic BMT;

8. Absence of congestive heart failure or pulmonary disease;

9. Serum bilirubin as parameter of liver function abnormalities not elevated above 3 x normal value;

10. Number of blood cells collected ("transplant"; PBSCT) being at least 2 x 108 nucleated cells/kg or 10 x 10^4 CFU-GM per kg or 2 x 10^6 CD34-positive cells per kg. In case of no or insufficient PBSCT, an adequate autologous marrow graft must have been collected;

11. Performance status of WHO grade 0, 1 or 2 at time of randomization;

12. Informed consent.

First randomization:

1. Patients with a concurrent active malignancy, except stage I cervix carcinoma and basocellular carcinoma;

2. Patients previously treated with chemotherapy;

3. Leukemia following from a documented myelodysplasia with a duration of more than 6 months;

4. Blastic crisis of chronic myeloid leukemia or leukemia developing from myeloproliferative diseases (e.g. polycythemia vera, myelofibrosis);

5. Renal or liver function abnormalities, i.e., creatinine and bilirubin of more than 3 x normal value, except if directly attributable to the leukemia (high serum lysosymes, hyperuricemia, leukemic cell infiltration);

6. HIV positive serology;

7. Patients with severe cardiac, pulmonary or neurologic disease;

8. Pregnancy.