Phase 2
N=27
Bendamustine Plus Rituximab (BR) for Relapsed or Progressive Marginal Zone B-cell Lymphoma (MZBCL)
Marginal Zone B-cell Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT02433795 ↗Enrolled (actual)
27
Serious AEs
11.1%
Results posted
Apr 2026
Primary outcome: Primary: Overall Response Rate — 81.8 Percentage
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- bendamustine plus rituximab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Seoul National University Hospital
- Primary completion
- Oct 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Response Rate |
81.8 | — |
| SECONDARY Progression-free Survival |
79.8; 64.5 | — |
| SECONDARY The 3-year Survival Rate |
92.28 | — |
Summary
This study will be conducted to evaluate the efficacy of Bendamustine Plus Rituximab (BR) in patients with relapsed or progressive Marginal Zone B-cell Lymphoma (MZBCL).
Eligibility Criteria
Inclusion Criteria
- Histologically confirmed CD20-positive nodal or extranodal MZBCL
- MZBCL patients who relapsed or progressed:
- At least one and a maximum of four prior lines of chemotherapy
- During or after the last chemotherapy or radiotherapy or
- Without progression within 6 months of the last dose of rituximab-based regimen
- Patients age ≥ 18 years
- ECOG PS 0-2
- At least one bidimensionally measurable disease
- Adequate hematologic, renal, and hepatic functions
- Women of child-bearing potential should use two appropriate methods of contraception during the study
- Written informed consent
Exclusion Criteria
- Not all of the above inclusion criteria are met.
- Prior chemotherapy within 4 weeks or radiotherapy within 6 weeks
- Corticosteroids during last 28 days except chronic administration of prednisolone at a dose of < 20mg/day for indications other than lymphomas
- Evidence of CNS involvement by lymphomas
- Active HBV/HCV infections, known HIV infection
- Prior diagnosis of cancers within 5 years, except cervical intraepithelial neoplasia type 1, localized non-melanoma skin cancer, or small differentiated thyroid cancer
- Serious concurrent disease:
- Patients who are pregnant or lactating
Data sourced from ClinicalTrials.gov (NCT02433795). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.