Table 2.
Inclusion and exclusion criteria.
Inclusion criteria | Exclusion criteria |
---|---|
Patients with primary or secondary AML, either de novo or relapsed/refractory, considered not candidates for conventional chemotherapy | Candidate for allogeneic bone marrow transplantation |
Karnofsky Performance status > 60% | Presence of central nervous system leukemia or any medical psychiatric condition |
Adequate hepatic and renal function | Active uncontrolled bacterial infection or HIV infection |
Age 18 years or greater | Uncontrolled diabetes and severe cardiovascular disease (NYHA) |
Documentation if written informed consent | History of hypotension |
At least 4 weeks from prior chemotherapy | Pregnant or breastfeeding |
Either men or women, accepting to practice effective contraception during the entire study period | Neuropathy > grade 2 and receipt of extensive radiation therapy, systemic chemotherapy. |