Clinical Trial: Bendamustine Plus Rituximab (BR) for Relapsed or Progressive Marginal Zone B-cell Lymphoma (MZBCL)
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: A Phase II Study of Bendamustine Plus Rituximab (BR) in Patients With Relapsed or Progressive Marginal Zone B-cell Lymphoma (MZBCL)
Brief Summary: This study will be conducted to evaluate the efficacy of Bendamustine Plus Rituximab (BR) in patients with relapsed or progressive Marginal Zone B-cell Lymphoma (MZBCL).
Detailed Summary: Multi-center trial, Phase II, non-randomized, open-label, single-arm study with combined therapy of bendamustine and rituximab in patients with MZBCL who has relapsed or progressive to prior chemotherapy or chemo-radiotherapy.
Sponsor: Seoul National University Hospital
Current Primary Outcome: Overall response rate based on Revised Response Criteria for Malignant Lymphoma [ Time Frame: 6 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Complete remission rate [ Time Frame: 6 months ]
- Safety based on NCI CTCAE version 4.0 [ Time Frame: 1 year ]
Original Secondary Outcome: Same as current
Information By: Seoul National University Hospital
Dates:
Date Received: April 5, 2015
Date Started: May 2015
Date Completion: May 2018
Last Updated: April 22, 2016
Last Verified: April 2016
