Phase II Study of a Proteasome Inhibitor, PS-341 (NSC 681239) in Chronic Myelogenous Leukemia (CML) in Chronic or Accelerated Phase
- 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
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Jorge Cortes, MD
M.D. Anderson Cancer Center
United States: Institutional Review Board
|MD Anderson Cancer Center at University of Texas||Houston, Texas 77030-4009|