Phase 2 study evaluating the efficacy and safety of the combination of Bendamustine, Rituximab and Dexamethazone (RBenda-D) for treatment of CD20-positive 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-UMIN000008145
- Lead Sponsor
- Kyoto Prefectural University of Medicine/K-LSG
- Brief Summary
The ORR was 88% with 58% attaining CR/CRu. A median follow-up time for all patients was 37 months. The 3-year PFS and OS rates were 75.5 +/- 8.1% (standard error) and 85.5 +/- 6.8%, respectively. The leading adverse event was myelosuppression. Incidence of grade 3-4 leukocytope nia, neutropenia, and lymphocytopenia was 55%, 67%, and 91%, respectively. The most frequent nonhematological adverse events were CMV antigenemia and rash (33% and 30%, respectively).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 33
Not provided
1. Patients are pregnant or lactating women. Patients (<1 year after menopause without surgical infertility) can not 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/microL). 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 Overall response rate
- Secondary Outcome Measures
Name Time Method Complete response rate Event-free survival Progression-free survival Safty Cycles completion rate for 3 or 6 cycles