Phase II Study of a Proteasome Inhibitor, PS-341 (NSC 681239) in Chronic Myelogenous Leukemia (CML) in Chronic or Accelerated Phase

OBJECTIVES:

• Determine the efficacy of bortezomib, in terms of response rate, duration of response, and survival of patients with Philadelphia chromosome-positive chronic myelogenous leukemia in chronic or accelerated phase.
• Assess the toxicity of this drug in these patients.

OUTLINE: Patients receive bortezomib intravenous (IV) over 3-5 seconds twice weekly on weeks 1-2. Treatment repeats every 3 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 5-30 patients will be accrued for this study within 15-30 months.