Evaluation on efficacy and safety of a combination therapy of rituximab with bendamustin in the patients with relapsed or resistnat low grade B-cell non-Hodgkin lymphoma

Evaluation on efficacy and safety of a combination therapy of rituximab with bendamustin in the patients with relapsed or resistnat low grade B-cell non-Hodgkin lymphoma - Evaluation on efficacy and safety of a combination therapy of rituximab with bendamustin in the patients with relapsed or resistnat low grade B-cell non-Hodgkin lymphoma

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000008638

Enrollment

Registered

2012-08-07

Start date

2012-06-01

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

patients with relapsed or resistant low grade B-cell non-Hodgkin lymphoma

Interventions

single

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)diagnosed as following Small lymphocytic lymphoma Lymphoplasmacytic lymphoma Splenic marginal zone B-cell lymphoma Extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue (MALT lymphoma) Nodal marginal zone B-cell lymphoma Mantle cell lymphoma 2) detaectable lesions (>1.5cm diameter) by CT scan 3) relapsed or resistant 4) >6 mo in estimated survival time 5) >20 yrs, <75 yrs 6) performance status 0-2 7) functional preservation of bone marrow, heart, lung, liver, and kidneys) 8) willingness to join this protocol

Exclusion criteria

Exclusion criteria: 1) infected definitely 2) critical complication (liver failure or renal failure) 3) critical complication of heart disease 4) critical complication of bowel disease 5) positive for HBsAb, HCVAb, or HIVAb 6) critical hemostatic disease 7) involved in CNS 8) febrile >38C (except for tumor fever) 9) critical complication of respiratory disease 10) concomittent presence of another malignancy 11) AIHA 12) allergy of bendamustine 13) pregnant or breast-feeding 14) allergy of rituximab 15) uncontrol of contraception 16) not eligible for this study

Design outcomes

Primary

Measure	Time frame
ORR	—

Secondary

Measure	Time frame
CR rate PFS adverse effect and data on laboratory findings	—

Countries

Japan

Contacts

Public ContactKeichiro Mihara

Hiroshima University Hospital Department of Hematology and Oncology

kmmihara@hiroshima-u.ac.jp082-257-5861

Outcome results

None listed

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