Clinical trial · Interventional
Bendamustine Plus Rituximab (BR) for Relapsed or Progressive Marginal Zone B-cell Lymphoma (MZBCL)
A Phase II Study of Bendamustine Plus Rituximab (BR) in Patients With Relapsed or Progressive Marginal Zone B-cell Lymphoma (MZBCL)
NCT02433795CI-TRIAL-00109132completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Marginal Zone B-cell Lymphoma | Marginal Zone Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bendamustine plus rituximab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Bendamustine plus rituximab(BR)
- description
- Intravenous bendamustine plus rituximab intravenously at 1st cycle and subcutaneously from 2nd cycle (to maximum 8th cycle).
- interventionNames
- Drug: bendamustine plus rituximab
Primary outcomes (1)
- measure
- Overall Response Rate
- timeFrame
- Up to disease progression, more than 30.12 months
- description
- Overall Response Rate (ORR) is defined as the proportion of patients with a confirmed Complete Response (CR) or Partial Response (PR) as assessed by the investigator. And ORR is based on Revised Response Criteria for Malignant Lymphoma
Secondary outcomes (2)
- measure
- Progression-free Survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically confirmed CD20-positive nodal or extranodal MZBCL 2. 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 3. Patients age ≥ 18 years 4. ECOG PS 0-2 5. At least one bidimensionally measurable disease 6. Adequate hematologic, renal, and hepatic functions 7. Women of child-bearing potential should use two appropriate methods of contraception during the study 8. Written informed consent Exclusion Criteria: 1. Not all of the above inclusion criteria are met. 2. Prior chemotherapy within 4 weeks or radiotherapy within 6 weeks 3. Corticosteroids during last 28 days except chronic administration of prednisolone at a dose of \< 20mg/day for indications other than lymphomas 4. Evidence of CNS involvement by lymphomas 5. Active HBV/HCV infections, known HIV infection 6. Prior diagnosis of cancers within 5 years, except cervical intraepithelial neoplasia type 1, localized non-melanoma skin cancer, or small differentiated thyroid cancer 7. Serious concurrent disease: 8. Patients who are pregnant or lactating
References
Publications (0)
Data not yet available
No reference posted for this study.