Marginal Zone B-cell LymphomaPhase 2NCT02433795
Bendamustine Plus Rituximab (BR) for Relapsed or Progressive Marginal Zone B-cell Lymphoma (MZBCL)
A Phase 2 study testing bendamustine plus rituximab in people with Marginal Zone B-cell Lymphoma, run by Seoul National University Hospital at 11 sites in South Korea.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Marginal Zone B-cell Lymphoma
- What is being tested?
- bendamustine plus rituximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 11 sitesSouth Korea
- Study dates
- May 2015to Oct 2019
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
South Korea11 sites
Hallym University Medical Center
Anyang-si
Chungnam National University
Daejeon
Gachon University Gil Medical Center
Incheon
Chonbuk National University Hospital
Jeonju, Jeollabuk-do, 54907
Gyeongsang National University Hospital
Jinju
Seoul National University Bundang Hospital
Seongnam
Inje Universit
Seoul
Korea Cancer Center Hospital
Seoul
Seoul National University Boramae Hospital
Seoul
Seoul National University Hospital
Seoul
The Catholic University of Korea
Seoul
About this study
Official title: A Phase II Study of Bendamustine Plus Rituximab (BR) in Patients With Relapsed or Progressive Marginal Zone B-cell Lymphoma (MZBCL)
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).
Read the 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.
- Conditions
- Marginal Zone B-cell Lymphoma
- Being tested
- bendamustine plus rituximab
- Keywords
- Marginal zone B-cell lymphoma, bendamustine plus rituximab
- Medical subject headings
- Lymphoma, B-Cell, Marginal Zone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bendamustine plus rituximabDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Bendamustine plus rituximab(BR) | Experimental | Intravenous bendamustine plus rituximab intravenously at 1st cycle and subcutaneously from 2nd cycle (to maximum 8th cycle). Receives: Drug: bendamustine plus rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to disease progression, more than 30.12 months
Secondary outcomes (2)
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.
Measured: Up to disease progression, more than 30.12 months
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.
Measured: From the 1st date of IP administration to the date of death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2015 (estimated)
- Study startMay 2015
- Primary completionOct 2019
- Study completionOct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Marginal Zone B-cell LymphomaStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, Tae Min Kim, Seoul National University Hospital
- Investigators
- Dae Seog Heo, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02433795
- Sponsor's protocol ID
- LY14-09
- Status last verified
- Sep 2021
- First submitted
- 5 Apr 2015
- Last updated
- 22 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No