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

Seoul National University

Status and phase: Completed; Phase 2

Conditions: Marginal Zone B-cell Lymphoma

Treatments: Drug: bendamustine plus rituximab

Study type: Interventional

Funder types: Other

Identifiers

NCT02433795

LY14-09

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 27 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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27 participants in 1 patient group

Bendamustine plus rituximab(BR)

Experimental group

Description:

Intravenous bendamustine plus rituximab intravenously at 1st cycle and subcutaneously from 2nd cycle (to maximum 8th cycle).

Treatment:

Drug: bendamustine plus rituximab