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| Name | Class |
|---|---|
| Gyeongsang National University Hospital | OTHER |
| Korea Cancer Center Hospital | OTHER |
| Seoul National University Boramae Hospital | OTHER |
| Hallym University Medical Center |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bendamustine plus rituximab(BR) | Experimental | Intravenous bendamustine plus rituximab intravenously at 1st cycle and subcutaneously from 2nd cycle (to maximum 8th cycle). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bendamustine plus rituximab | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate | Overall Response Rate (ORR) is defined as the proportion of patients with a confirmed Complete Response (CR) or Partial Response (PR) as assessed by the investigator. And ORR is based on Revised Response Criteria for Malignant Lymphoma | Up to disease progression, more than 30.12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival | Progression-Free Survival (PFS) rate is defined as the proportion of patients who are alive and have not experienced disease progression at a specified time point and is defined from the date of first dose (or randomization) to the earliest date of objective disease progression or death from any cause, whichever occurs first. | Up to disease progression, more than 30.12 months |
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Inclusion Criteria:
Histologically confirmed CD20-positive nodal or extranodal MZBCL
MZBCL patients who relapsed or progressed:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Dae Seog Heo, MD, PhD | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chonbuk National University Hospital | Jeonju | Jeollabuk-do | 54907 | South Korea | ||
| Hallym University Medical Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | Bendamustine Plus Rituximab(BR) | Bendamustine plus rituximab combination chemotherapy therapy. Bendamustine was administered at 90mg/m2 intravenously on days 1-2 up to 6th cycle. Rituximab was administered at 375mg/m2 intravenously on day 1 at 1st cycle. Rituximab was administered at 1400mg subcutaneously on day 1 from 2nd cycle every 4 weeks up to 8th cycle, disease progression, or intolerable toxicities. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 20, 2017 |
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| 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 |
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| The 3-year Survival Rate | The 3-year survival rate is defined as the proportion of patients alive at 3 years from the date of first dose, estimated using the Kaplan-Meier method. And it was calculated at the point of data cut-off. | From the 1st date of IP administration to the date of death |
| 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 |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Bendamustine Plus Rituximab(BR) | Intravenous bendamustine plus rituximab intravenously at 1st cycle and subcutaneously from 2nd cycle (to maximum 8th cycle). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | year |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| ECOG performance status | ECOG PS to assess a patient's level of functioning, including the ability to carry out daily activities and self-care. 0: Fully active; able to carry on all pre-disease activities without restriction. 1: Restricted in physically strenuous activity but ambulatory and able to carry out light work (e.g., office work, light housework). 2: Ambulatory and capable of all self-care but unable to carry out any work activities; up and about more than 50% of waking hours. | Count of Participants | Participants |
| |||||||||||||||||
| Ann Arbor stage | Ahn Arbor stage at the study entry. Stage II: Involvement of two or more lymph node regions on the same side of the diaphragm. Stage III: Involvement of lymph node regions on both sides of the diaphragm. Stage IV: Diffuse or disseminated involvement of one or more extranodal organs, with or without lymph node involvement. | Count of Participants | Participants |
| |||||||||||||||||
| International Prognostic Index | International Prognostic Index at the study entry | Count of Participants | Participants |
| |||||||||||||||||
| Subtype | Subtype at enrollment | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Overall Response Rate | Overall Response Rate (ORR) is defined as the proportion of patients with a confirmed Complete Response (CR) or Partial Response (PR) as assessed by the investigator. And ORR is based on Revised Response Criteria for Malignant Lymphoma | Of the 27 eligible patients, 26 were evaluated for a response. One patient, a 78-year-old female, was not evaluated because of early treatment discontinuation following the development of life-threatening pneumonia and acute respiratory failure after the first cycle. | Posted | Number | 90% Confidence Interval | Percentage | Up to disease progression, more than 30.12 months |
|
|
| |||||||||||||||||||||||||
| Secondary | Progression-free Survival | Progression-Free Survival (PFS) rate is defined as the proportion of patients who are alive and have not experienced disease progression at a specified time point and is defined from the date of first dose (or randomization) to the earliest date of objective disease progression or death from any cause, whichever occurs first. | Of the 27 eligible patients, 26 were evaluated for a response. One patient, a 78-year-old female, was not evaluated because of early treatment discontinuation following the development of life-threatening pneumonia and acute respiratory failure after the first cycle. | Posted | Number | 95% Confidence Interval | Percentage | Up to disease progression, more than 30.12 months |
|
| ||||||||||||||||||||||||||
| Secondary | The 3-year Survival Rate | The 3-year survival rate is defined as the proportion of patients alive at 3 years from the date of first dose, estimated using the Kaplan-Meier method. And it was calculated at the point of data cut-off. | Posted | Number | 95% Confidence Interval | Percentage | From the 1st date of IP administration to the date of death |
|
|
All adverse events were recorded from the date of the first administration of the study drug up to 40 weeks (including 28 days after the last administration). All serious adverse events were recorded from the date of informed consent signature up to 40 weeks. All-cause mortality was assessed from the date of study enrollment until the data cut-off date up to 5.2 years (July 31, 2019).
All adverse events will be recorded from the date of the first administration of the study drug until 28 days after the last administration of the study drug.
All serious adverse events will be recorded from the date of informed consent signature until 28 days after the last administration of the study drug.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bendamustine Plus Rituximab(BR) | Intravenous bendamustine plus rituximab intravenously at 1st cycle and subcutaneously from 2nd cycle (to maximum 8th cycle). | 0 | 27 | 3 | 27 | 14 | 27 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lung infection | Infections and infestations | Non-systematic Assessment |
| ||
| Hepatitis B reactivation | Infections and infestations | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Anorexia | Psychiatric disorders | Non-systematic Assessment |
| ||
| Fatigue | General disorders | Non-systematic Assessment |
| ||
| Skin rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Fever | General disorders | Non-systematic Assessment |
| ||
| Headache | General disorders | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ji-Sook Kim | Seoul National University Hospital | 82-10-2586-6440 | kbj3075814@snu.ac.kr |
| Jan 18, 2026 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D018442 | Lymphoma, B-Cell, Marginal Zone |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000069461 | Bendamustine Hydrochloride |
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Ⅳ |
|
| High-intermediate risk |
|
| High risk |
|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
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