131I-rituximab for Relapsed or Refractory Marginal Zone B-cell Lymphoma
Recruitment status was: Recruiting
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.
Relapsed or Refractory Marginal Zone B-cell Lymphoma
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of 131I-rituximab for Patients With Relapsed or Refractory Marginal Zone B-cell Lymphoma|
- Overall response rate [ Time Frame: up to 5 years ]International Working Group Response criteria
- 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
|Study Start Date:||October 2011|
|Estimated Study Completion Date:||September 2016|
|Estimated Primary Completion Date:||September 2014 (Final data collection date for primary outcome measure)|
131I-rituximab treatment interval at least 4 weeks up to maximum 6 cycles
Please refer to this study by its ClinicalTrials.gov identifier: NCT01678404
|Korea, Republic of|
|Korea Cancer Center Hospital, Korea Institute of Radiological and Medical Sciences|
|Seoul, Korea, Republic of, 139-706|
|Principal Investigator:||Hye Jin Kang, M.D.||Korea Cancer Center Hospital, Korea Institute of Radiological and Medical Sciences|