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

• Status: Completed
• Trial end date: 2019-10-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Hospital
• Collaborators: Chonbuk National University Hospital; Chungnam National University; Gachon University Gil Medical Center; Gangnam Severance Hospital; Gyeongsang National University Hospital; Hallym University Medical Center; Inje University; Korea Cancer Center Hospital; Seoul National University Boramae Hospital; Seoul National University Bundang Hospital; The Catholic University of Korea; Wonju Severance Christian Hospital
• Treatments: Bendamustine Hydrochloride; Rituximab

Criteria

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