Phase II Study of Proteasome Inhibitor PS-341 For Patients With Relapsed or Refractory B Cell Lymphomas Previously Treated With Chemotherapy
Patients were stratified, based on preclinical data, into arm A (mantle-cell lymphoma) or
arm B (other B-cell lymphomas) without limitation in number of prior therapies. Bortezomib
was administered as an intravenous push (1.5 mg/m2) on days 1, 4, 8, and 11 every 21 days
for a maximum of six cycles.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Patients with Response to PS-341
Patient response evaluated according to criteria of Cheson et al. Endoscopy obtained every two cycles to evaluate response using Complete Response (CR), Partial Response (PR), Progressive Disease, or Stable Disease.
Every two 21-day cycles
Luis Fayad, MD
UT MD Anderson Cancer Center
United States: Food and Drug Administration
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