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

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ClinicalTrials.gov Identifier: NCT02433795

Recruitment Status : Completed

First Posted : May 5, 2015

Last Update Posted : December 3, 2020

Sponsor:

Collaborators:

Gyeongsang National University Hospital

Korea Cancer Center Hospital

Seoul National University Boramae Hospital

Hallym University Medical Center

Inje University

Gangnam Severance Hospital

Chonbuk National University Hospital

Chungnam National University

The Catholic University of Korea

Wonju Severance Christian Hospital

Gachon University Gil Medical Center

Seoul National University Bundang Hospital

Information provided by (Responsible Party):

Tae Min Kim, Seoul National University Hospital

Study Description

Brief 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).

Condition or disease	Intervention/treatment	Phase
Marginal Zone B-cell Lymphoma	Drug: bendamustine plus rituximab	Phase 2

Detailed 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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	27 participants
Allocation:	N/A
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	A Phase II Study of Bendamustine Plus Rituximab (BR) in Patients With Relapsed or Progressive Marginal Zone B-cell Lymphoma (MZBCL)
Study Start Date :	May 2015
Actual Primary Completion Date :	October 2019
Actual Study Completion Date :	October 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Drug Information available for: Bendamustine hydrochloride Bendamustine Rituximab

Genetic and Rare Diseases Information Center resources: Lymphosarcoma B-cell Lymphoma Marginal Zone Lymphoma

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Bendamustine plus rituximab(BR) Intravenous bendamustine plus rituximab intravenously at 1st cycle and subcutaneously from 2nd cycle (to maximum 8th cycle).	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

Outcome Measures

Primary Outcome Measures :

Overall response rate based on Revised Response Criteria for Malignant Lymphoma [ Time Frame: 6 months ]

Secondary Outcome Measures :

Complete remission rate [ Time Frame: 6 months ]
Safety based on NCI CTCAE version 4.0 [ Time Frame: 1 year ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02433795

Locations

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Korea, Republic of
Chonbuk National University Hospital
Jeonju, Jeollabuk-do, Korea, Republic of, 54907
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
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, Korea, Republic of

Sponsors and Collaborators

Seoul National University Hospital