Acute myelocytic leukemia.
Conditions
Interventions
Patients (except AML-M3 or t(15
17)) will be randomized on entry between:
Arm A:
Cycle I: idarubicin + cytarabin
Cycle II: amsacrin + cytarabin
Arm B:
Cycle I: idarubicin + cytarabin + G-CSF
Cycle II: amsacrin +
17) will receive arm A treatment.
Patients in CR with good risk will proceed to Cycle III: Mitoxantrone + VP-16.
Patients in CR with poor risk and a HLA matched donor will proceed to Allo BMT.
Pat
Sponsors
Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON)
P/a HOVON Data Center
Erasmus MC - Daniel den Hoed
Postbus 5201
3008 AE Rotterdam
Tel: 010 4391568
Fax: 010 4391028
e-mail: hdc@erasmusmc.nl
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CR rate. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Disease-free survival; 2. Overall survival. | — |
Contacts
Public ContactB. Löwenberg
Erasmus Medical Center, Daniel den Hoed Cancer Center, Department of Hematology, P.O. Box 5201
Outcome results
None listed