Clinical Trial: Trial of Bortezomib, Cytarabine, and Dexamethasone in Mantle Cell Lymphoma

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Phase 2 Trial to Evaluate the Efficacy of Bortezomib, Cytarabine, and Dexamethasone in Patients With Relapsed or Refractory Mantle Cell Lymphoma

Brief Summary: The purpose of this study is to determine whether bortezomib, cytarabine, and dexamethasone are effective in the treatment of relapsed or refractory mantle cell lymphoma after 1 to 3 lines of previous treatment.

Detailed Summary:
Sponsor: Seoul National University Hospital

Current Primary Outcome: Overall response [ Time Frame: within 28 days after the last cycle of treatment ]

Lugano classification


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Complete response [ Time Frame: within 28 days after the last cycle of treatment ]
    Lugano classification
  • Overall survival [ Time Frame: 5 years ]
    Interval from registration to death from any cause
  • Progression-free survival [ Time Frame: 5 years ]
    Interval from registration to progression or death from any cause


Original Secondary Outcome: Same as current

Information By: Seoul National University Hospital

Dates:
Date Received: July 19, 2016
Date Started: October 2016
Date Completion: June 2025
Last Updated: November 1, 2016
Last Verified: November 2016