Clinical Trial: 131I-rituximab for Relapsed or Refractory Marginal Zone B-cell Lymphoma

Study Status: Active, not recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: A Phase II Study of 131I-rituximab for Patients With Relapsed or Refractory Marginal Zone B-cell Lymphoma

Brief Summary:

Marginal zone B-cell lymphoma (MZL) is a lymphoma originated from B-cell in lymph node with variable differentiation status, which is distributed to a variety of organs.

A high response rate and long term survival is possible through surgery or radiation therapy alone in the case of limited disease. However frequent relapse and progression is observed despite of long term survival. The treatment after relapse has not been established yet.

So we investigate the efficacy of radioimmunotherapy using 131I-rituximab in refractory or relapsed patients with MZL.


Detailed Summary:
Sponsor: Korea Cancer Center Hospital

Current Primary Outcome: Overall response rate [ Time Frame: up to 5 years ]

International Working Group Response criteria


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Response duration [ Time Frame: up to 5 years ]
  • Progression free survival [ Time Frame: up to 5 years ]
  • Overall survival [ Time Frame: up to 5 years ]
  • Number of Adverse Events [ Time Frame: up to 5 years ]
    grading the adverse events using CTCAE version 4.03


Original Secondary Outcome: Same as current

Information By: Korea Cancer Center Hospital

Dates:
Date Received: September 4, 2012
Date Started: October 2011
Date Completion: September 2016
Last Updated: September 4, 2012
Last Verified: August 2012