Phase 1/2 study of the combination of Bendamustine and Rituximab for treatment of elderly relapsed or refractory indolent B-cell non-Hodgkin lymphoma and mantle cell lymphoma.
- Conditions
- relapsed or refractory indolent B-cell non-Hodgkin lymphoma and mantle cell lymphoma.
- Registration Number
- JPRN-UMIN000006513
- Lead Sponsor
- Kinki University School of Medecine Division of Hematology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 43
Not provided
1. Patients are pregnant or lactating women. Patients (<1 year after menopause, without surgical infertility) can't or will not use birth control during the treatment. 2. Patients have active other malignant diseases including simultaneous cancer and disease free state within 5 years after treatment for other cancer except curable intramural cancer by local treatment. 3. Patients have mental disease or disorder with difficulty in participating in the clinical trial. 4. HBs antigen positive 5. HCV antibody positive 6. HIV antibody positive 7. Patients have much tumor cell in peripheral blood (>=25,000/uL). 8. Patients received allogeneic hematopoietic [hemopoietic] stem cell transplant. 9. Patients have interstitial lung disease or fibroid lung. 10. Patients have CNS invasion. 11. Patients already received bendamustine treatment. 12. Patients are inappropriate for rituximab treatment. 13. Patients have severe allergic symptoms. 14. Inadequate for clinical trial entry by the attending physicians.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Phase 1 recommended dose dose limiting toxicity maximum tolerated dose overall response rate Phase 2 overall response rate
- Secondary Outcome Measures
Name Time Method Phase 1 overall response rate Phase 2 complete response rate progression-free survival safty