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

Marginal Zone B-cell Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02433795
• Other study ID #: LY14-09
• Status: Completed
• Phase: Phase 2
• Start date: May 2015
• Est. completion date: October 2019

Study information

• Verified date: September 2021
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: October 2019
• Est. primary completion date: October 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, B-Cell, Marginal Zone
• Marginal Zone B-cell Lymphoma

Intervention

Drug:
• bendamustine plus rituximab
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

Locations

Country	Name	City	State
Korea, Republic of	Hallym University Medical Center	Anyang-si
Korea, Republic of	Chungnam National University	Daejeon
Korea, Republic of	Gachon University Gil Medical Center	Incheon
Korea, Republic of	Chonbuk National University Hospital	Jeonju	Jeollabuk-do
Korea, Republic of	Gyeongsang National University Hospital	Jinju
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam
Korea, Republic of	Inje Universit	Seoul
Korea, Republic of	Korea Cancer Center Hospital	Seoul
Korea, Republic of	Seoul National University Boramae Hospital	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	The Catholic University of Korea	Seoul

Sponsors (13)

Lead Sponsor

Collaborator

Seoul National University Hospital

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

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate based on Revised Response Criteria for Malignant Lymphoma		6 months
Secondary	Complete remission rate		6 months
Secondary	Safety based on NCI CTCAE version 4.0		1 year