Phase II Study of Bortezomib as a Single Agent in Patients with Previously Untreated or Relapsed/Refractory Acute Myeloid Leukemia Ineligible for Intensive Therapy

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.