Bendamustine Plus Rituximab (BR) for Relapsed or Progressive Marginal Zone B-cell Lymphoma (MZBCL)
NCT ID: NCT02433795
Last Updated: 2021-09-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
27 participants
INTERVENTIONAL
2015-05-31
2019-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Bendamustine plus rituximab(BR)
Intravenous bendamustine plus rituximab intravenously at 1st cycle and subcutaneously from 2nd cycle (to maximum 8th cycle).
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Gyeongsang National University Hospital
OTHER
Korea Cancer Center Hospital
OTHER
Seoul National University Boramae Hospital
OTHER
Hallym University Medical Center
OTHER
Inje University
OTHER
Gangnam Severance Hospital
OTHER
Chonbuk National University Hospital
OTHER
Chungnam National University
OTHER
The Catholic University of Korea
OTHER
Wonju Severance Christian Hospital
OTHER
Gachon University Gil Medical Center
OTHER
Seoul National University Bundang Hospital
OTHER
Seoul National University Hospital
OTHER
Responsible Party
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Tae Min Kim
Professor
Principal Investigators
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Dae Seog Heo, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Locations
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Chonbuk National University Hospital
Jeonju, Jeollabuk-do, South Korea
Hallym University Medical Center
Anyang-si, , South Korea
Chungnam National University
Daejeon, , South Korea
Gachon University Gil Medical Center
Incheon, , South Korea
Gyeongsang National University Hospital
Jinju, , South Korea
Seoul National University Bundang Hospital
Seongnam, , South Korea
Inje Universit
Seoul, , South Korea
Korea Cancer Center Hospital
Seoul, , South Korea
Seoul National University Boramae Hospital
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
The Catholic University of Korea
Seoul, , South Korea
Countries
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Other Identifiers
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LY14-09
Identifier Type: -
Identifier Source: org_study_id
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