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.

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. - Phase 2 study 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.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000008145

Enrollment

Registered

2012-06-12

Start date

2011-07-21

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Relapsed or refractory indolent B-cell non-Hodgkin lymphoma and mantle cell lymphoma.

Interventions

Bendamustine + Rituximab + Dexamethazone Rituximab Day 1 375mg/m2/day Bendamustine Day 2, Day 3 90mg/m2/day Dxamethazone Day 1,Day 2 20mg/m2/day div(or po) Dxamethazone Day 3,Day 4 ,Day5 10mg/m

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with pathologically confirmed indolent B-cell non-Hodgkin lymphoma or mantle cell lymphoma. 2. Patients had received prior treatment of rituximab in combination with chemotherapy (without corticosteroid alone) or antibody treatments that rituximab alone or ibritumomab tiuxetan, and were considered no response or relapse after CR or PR. 3. CD20 positive 4. Patients have measurable lesion that measured >=1.5cm in a single dimension by CT. 5. Patients aged 20-80 years. 6. PS(ECOG) 0-2 7. Patients meet all following standard Absolute neutrophil count >= 1,500/mm3 Platelet count >= 80,000/mm3 AST and ALT < 2.5 times facility criteria. Total bilirubin = <2.0mg/dl Creatinine = <2.0mg/dl Cardiac electro gram : nomal or no abnormality required treatment SpO2 : >= 90% 8. Patients have a life expectancy > 3 months. 9. Written informed consent.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
Overall response rate	—

Secondary

Measure	Time frame
Complete response rate Event-free survival Progression-free survival Safty Cycles completion rate for 3 or 6 cycles	—

Countries

Japan

Contacts

Public ContactYosuke Matsumoto

Kyoto Prefectural University of Medicine Division of Hematilogy and Oncology

yosuke-m@koto.kpu-m.ac.jp075-251-5740

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026