Phase II clinical trial of combination chemotherapy with bendamustine and rituximab for relapsed or refractory CD20 positive indolent B-cell non-Hodgkin lymphoma and mantle cell lymphoma patients
Phase 2
- Conditions
- CD20 positive indolent B-cell non-Hodgkin lymphoma and mantle cell lymphoma
- Registration Number
- JPRN-UMIN000008024
- Lead Sponsor
- Kyoto University Hematology Study Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 45
Inclusion Criteria
Not provided
Exclusion Criteria
1, pregnant or breast-feeding women 2, patients with active second cancer 3, HBs antigen positive or HBV-DNA positive patients 4, HIV antibody positive patients 5, patients who have been treated with stem cell transplantation 6, interstitial pneumonitis or pulmonary fibrosis 7, patients with central nervous system involvement 8, patients who have already received bendamustine treatment
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression free survival
- Secondary Outcome Measures
Name Time Method 1, response rate 2, complete response rate 3, overall survival 4, event-free survival 5, proportion of patients completing 3 and 6 cycles of treatment 6, incidence of grade 3 and 4 adverse events 7, assessment of immunological parameters during and after treatment