Bendamustine Plus Rituximab (BR) for Relapsed or Progressive Marginal Zone B-cell Lymphoma (MZBCL)

Study Overview
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Brief Summary
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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).

Detailed Description
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Multi-center trial, Phase II, non-randomized, open-label, single-arm study with combined therapy of bendamustine and rituximab in patients with MZBCL who has relapsed or progressive to prior chemotherapy or chemo-radiotherapy.

Official Title
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A Phase II Study of Bendamustine Plus Rituximab (BR) in Patients With Relapsed or Progressive Marginal Zone B-cell Lymphoma (MZBCL)

Conditions
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Marginal Zone B-cell Lymphoma

Intervention / Treatment
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* Drug: bendamustine plus rituximab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bendamustine plus rituximab(BR)<br>Intravenous bendamustine plus rituximab intravenously at 1st cycle and subcutaneously from 2nd cycle (to maximum 8th cycle). | Drug: bendamustine plus rituximab<br>* Bendamustine 90mg/m2 IV on days 1-2 up to 6th cycle Rituximab 375mg/m2 IV on day 1 at 1st cycle Rituximab 1400mg SC on day 1 from 2nd cycle every 4 weeks up to 8th cycle<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate based on Revised Response Criteria for Malignant Lymphoma |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete remission rate |  | 6 months | 
| Safety based on NCI CTCAE version 4.0 |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Marginal zone B-cell lymphoma, bendamustine plus rituximab