Clinical Trial: Phase II Study of VELCADE for Relapsed or Refractory T-cell Prolymphocytic Leukemia
Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional
Official Title: Phase II Study of Bortezomib (VELCADE) for the Treatment of Relapsed or Refractory T-cell Prolymphocytic Leukemia
Brief Summary: We hope to learn more about the clinical efficacy of bortezomib in T-cell prolymphocytic leukemia. Patients will be selected as a possible participant in this study because they have a bone marrow disorder known as T-cell prolymphocytic leukemia (T-cell PLL) which does not tend to respond well to conventional treatment with chemotherapy.
Detailed Summary:
Sponsor: Stanford University
Current Primary Outcome: Assess the clinical activity, as represented by the overall response rate (complete response + partial response), of bortezomib in patients with relapsed or refractory T-cell prolymphocytic leukemia (PLL) [ Time Frame: 1 year ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- prolymphocytic leukemia (PLL) [ Time Frame: 1 year ]
- Evaluate time to progression in patients with T-cell prolymphocytic leukemia (PLL) [ Time Frame: 1 year ]
- Evaluate the 1-year progression free survival (PFS), and 1-year overall survival (OS) in patients with T-cell prolymphocytic leukemia (PLL) treated with Velcade compared to historical controls [ Time Frame: 1 year ]
Original Secondary Outcome: Same as current
Information By: Stanford University
Dates:
Date Received: July 12, 2010
Date Started: June 2010
Date Completion:
Last Updated: May 15, 2013
Last Verified: May 2013
