Trial Outcomes & Findings for Bendamustine Plus Rituximab (BR) for Relapsed or Progressive Marginal Zone B-cell Lymphoma (MZBCL) (NCT NCT02433795)

Last Updated: 2026-04-22

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

27 participants

Primary outcome timeframe

Up to disease progression, more than 30.12 months

Results posted on

2026-04-22

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	27
Overall Study COMPLETED	27
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bendamustine Plus Rituximab(BR) n=27 Participants Intravenous bendamustine plus rituximab intravenously at 1st cycle and subcutaneously from 2nd cycle (to maximum 8th cycle).
Age, Continuous	66 year n=60 Participants
Sex: Female, Male Female	13 Participants n=60 Participants
Sex: Female, Male Male	14 Participants n=60 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=60 Participants
Race (NIH/OMB) Asian	27 Participants n=60 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=60 Participants
Race (NIH/OMB) Black or African American	0 Participants n=60 Participants
Race (NIH/OMB) White	0 Participants n=60 Participants
Race (NIH/OMB) More than one race	0 Participants n=60 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=60 Participants
ECOG performance status ECOG PS 0-1	26 Participants n=60 Participants
ECOG performance status ECOG PS 2	1 Participants n=60 Participants
Ann Arbor stage Ⅱ	4 Participants n=60 Participants
Ann Arbor stage Ⅲ	2 Participants n=60 Participants
Ann Arbor stage Ⅳ	21 Participants n=60 Participants
International Prognostic Index Low risk	4 Participants n=60 Participants
International Prognostic Index Low-intermediate risk	12 Participants n=60 Participants
International Prognostic Index High-intermediate risk	9 Participants n=60 Participants
International Prognostic Index High risk	2 Participants n=60 Participants
Subtype Extranodal mariginal zone lymphome (EMZL)	14 Participants n=60 Participants
Subtype Nodal mariginal zone lymphome (NMZL)	13 Participants n=60 Participants

PRIMARY outcome

Timeframe: Up to disease progression, more than 30.12 months

Population: 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.

Outcome measures

Outcome measures
Measure	Bendamustine Plus Rituximab(BR) n=26 Participants Intravenous bendamustine plus rituximab intravenously at 1st cycle and subcutaneously from 2nd cycle (to maximum 8th cycle).
Overall Response Rate	81.8 Percentage Interval 64.99 to 89.91

SECONDARY outcome

Timeframe: Up to disease progression, more than 30.12 months

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.

Outcome measures

Outcome measures
Measure	Bendamustine Plus Rituximab(BR) n=26 Participants Intravenous bendamustine plus rituximab intravenously at 1st cycle and subcutaneously from 2nd cycle (to maximum 8th cycle).
Progression-free Survival The estimated 2-year PFS rate	79.8 Percentage Interval 58.04 to 91.1
Progression-free Survival The estimated 3-year PFS rate	64.5 Percentage Interval 37.14 to 82.37

SECONDARY outcome

Timeframe: From the 1st date of IP administration to the date of death

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.

Outcome measures

Outcome measures
Measure	Bendamustine Plus Rituximab(BR) n=26 Participants Intravenous bendamustine plus rituximab intravenously at 1st cycle and subcutaneously from 2nd cycle (to maximum 8th cycle).
The 3-year Survival Rate	92.28 Percentage Interval 72.48 to 98.02

Adverse Events

Bendamustine Plus Rituximab(BR)

Serious events: 3 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Bendamustine Plus Rituximab(BR) n=27 participants at risk Intravenous bendamustine plus rituximab intravenously at 1st cycle and subcutaneously from 2nd cycle (to maximum 8th cycle).
Infections and infestations Lung infection	11.1% 3/27 • 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.
Infections and infestations Hepatitis B reactivation	3.7% 1/27 • 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.

Other adverse events

Other adverse events
Measure	Bendamustine Plus Rituximab(BR) n=27 participants at risk Intravenous bendamustine plus rituximab intravenously at 1st cycle and subcutaneously from 2nd cycle (to maximum 8th cycle).
Gastrointestinal disorders Nausea	51.9% 14/27 • 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.
Psychiatric disorders Anorexia	37.0% 10/27 • 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.
General disorders Fatigue	33.3% 9/27 • 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.
Skin and subcutaneous tissue disorders Skin rash	29.6% 8/27 • 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.
General disorders Fever	25.9% 7/27 • 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.
General disorders Headache	22.2% 6/27 • 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.

Additional Information

Ji-Sook Kim

Seoul National University Hospital

Phone: 82-10-2586-6440

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place