Clinical PhII Study: Investigation for safety and efficacy of bendamustine and rituximab, B-R combination therapy for the patients of recurrent and/or refractory low-grade B cell lymphoma or mantle cell lymphoma previously treated with one or two regimen including rituximab

Clinical PhII Study: Investigation for safety and efficacy of bendamustine and rituximab, B-R combination therapy for the patients of recurrent and/or refractory low-grade B cell lymphoma or mantle cell lymphoma previously treated with one or two regimen including rituximab - BRB Study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000005613

Enrollment

Registered

2011-05-20

Start date

2011-05-01

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 and/or refractory low-grade B cell non-Hodgkin lymphoma

Interventions

1st cycle

Administrate Rituximab 375mg/m2 DIV for d1 and Bendamustine 90 mg/m2 DIV for d 2 and d 3 and observe for 25 ds. 2nd to 4th cycle

Rituximab 375mg/m2 DIV d1 and Bendamustine 90 mg/m2 DIV d1 and d2 and observe for 26 ds.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Low-grade B cell non-Hodgkin lymphoma pts confirmed with histology or cytology 2. Pt who were previously treated with 1 or 2 regimen including rituximab 3. Refractory or recurrent disease pts 4. CD20 positive 5. Mesureable disease 6. ECOG performance status 0-2 7. ANC=1500 or more, Hb=9.0 or more, Platelet count=100000 or more, AST, ALT, and ALP less than 2.5XUL, TB and Cr less than 1.5XUL 8. Normal ECG or asymptomatic minor ECG change 9. Expected surviaval time more than 3 M 10.Written informed consent obtained

Exclusion criteria

Exclusion criteria: 1. Pregnancy, brest-feedings, or pts who would be pregnant 2. Active double cancer 3. Psychotics judged could not be difficutlt to attend 4. Severe complication and/or infection 5. Liver cirrhosis 6. Interstitial pneumonitis 7. Tumor cells in PB are 25000/uL or more 8. CNS invasion 9. Past history of bendamustine administration 10.Inappropriate to administer rituximab 11.Sever hypersensitity on any agents 12.Judged to be inappropriate

Design outcomes

Primary

Measure	Time frame
Overall response rate (best response)	—

Secondary

Measure	Time frame
Adverse events Complete response rate TTP OS HT rate SPM rate	—

Countries

Japan

Contacts

Public ContactKimihiro Matsumoto

Keio University School of Medicine, Division of Hematology Hematology

kmatumoto1123@gmail.com03-3353-1211

Outcome results

None listed

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