A clinical phase II study assessing the safety and efficacy of readministration of bendamustine monotherapy or bendamustine/rituximab for relapsed low grade B cell non-Hodgkin lymphoma or mantle cell lymphoma patients previously treated with bendamustine containing chemothearpy
Not Applicable
- Conditions
- low-grade B cell non-Hodgkin lymphoma, Mantle cell lymphoma
- Registration Number
- JPRN-UMIN000010923
- Lead Sponsor
- KEIO BRB Study Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 38
Inclusion Criteria
Not provided
Exclusion Criteria
1. patients who are pregnant/female patients who are unwilling to take prevention measures for contraception during treatment 2. patients with active cancer 3. patients wih mental illnesses that the treating physician judges difficult to participate in the study 4. patients with circulating tumor cells > 25,000 /uL 5. patients with severe allergic reaction to medication 6. patients with active infectious diseases 7. patients who are positive for HBs antigen or HBV-DNA 8. patients who are judged inadequate to participate in the study according to the treating physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall response rate after 2 cycles of thearpy
- Secondary Outcome Measures
Name Time Method 1. Best overall response rate 2. complete response rate 3. progression free survival 4. safety 5. safety and efficacy after each cycle of treatment