Phase II study of remission induction therapy with bendamustine and rituximab combination (BR) therapy followed by consolidation therapy with 90Y-labeled iburitumomab tiuxetan for relapsed follicular lymphoma.(BRiZ2012 protocol)
Phase 2
- Conditions
- follicular lymphoma
- Registration Number
- JPRN-UMIN000008793
- Lead Sponsor
- Society of Lymphoma Treatment in Japan (SoLTJ)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 28
Inclusion Criteria
Not provided
Exclusion Criteria
Histologically confirmed CD20 negative lymphoma by biopsy at the time of diagnosis or relapse. Having active double or multiple cancer. Having infectious disease with poor control (including active tuberculosis ). Having the central nervous system infiltration of the lymphoma. Intolerant to the drugs using in this study. If any of HIV antibody, HBs antigen or HCV antibody positivity. Pregnant (including possibility), nursing women. Had received bendamustine administration previously.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression-free survival (PFS) for 2 years after the completion of ibritumomab tiuxetan therapy
- Secondary Outcome Measures
Name Time Method Response rate (RR) after BR therapy Complete response rate (CRR) after BR therapy RR after ibritumomab tiuxetan therapy CRR after ibritumomab tiuxetan therapy PFS after ibritumomab tiuxetan therapy 2-year overall survival (OS) after ibritumomab tiuxetan therapy Safety