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

NCT02433795 | Completed Phase 2 Results

• 1 other identifier: LY14-09
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 11

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).

Conditions

Marginal Zone B-cell Lymphoma

Keywords

Marginal zone B-cell lymphoma; bendamustine plus rituximab

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Progression-free Survival

  Up to disease progression, more than 30.12 months

• The 3-year Survival Rate

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

Study Arms (1)

Bendamustine plus rituximab(BR)

EXPERIMENTAL

Intravenous bendamustine plus rituximab intravenously at 1st cycle and subcutaneously from 2nd cycle (to maximum 8th cycle).

Drug: bendamustine plus rituximab

Interventions

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

Bendamustine plus rituximab(BR)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Gyeongsang National University Hospital: collaborator
• Korea Cancer Center Hospital: collaborator
• Seoul National University Boramae Hospital: collaborator
• Hallym University Medical Center: collaborator
• Inje University: collaborator
• Gangnam Severance Hospital: collaborator
• Chonbuk National University Hospital: collaborator
• Chungnam National University: collaborator
• The Catholic University of Korea: collaborator
• Wonju Severance Christian Hospital: collaborator
• Gachon University Gil Medical Center: collaborator
• Seoul National University Bundang Hospital: collaborator

Study Sites (11)

Chonbuk National University Hospital

Jeonju, Jeollabuk-do, 54907, South Korea

Location

Hallym University Medical Center

Anyang-si, South Korea

Location

Chungnam National University

Daejeon, South Korea

Location

Gachon University Gil Medical Center

Incheon, South Korea

Location

Gyeongsang National University Hospital

Jinju, South Korea

Location

Seoul National University Bundang Hospital

Seongnam, South Korea

Location

Inje Universit

Seoul, South Korea

Location

Korea Cancer Center Hospital

Seoul, South Korea

Location

Seoul National University Boramae Hospital

Seoul, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

The Catholic University of Korea

Seoul, South Korea

Location

MeSH Terms

Conditions

Lymphoma, B-Cell, Marginal Zone

Interventions

Bendamustine Hydrochloride; Rituximab

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Ji-Sook Kim
• Organization: Seoul National University Hospital

kbj3075814@snu.ac.kr

82-10-2586-6440

Study Officials

• Dae Seog Heo, MD, PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 5, 2015
• First Posted: May 5, 2015
• Study Start: May 1, 2015
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: April 22, 2026
• Results First Posted: April 22, 2026

Record last verified: 2021-09

Locations

KR (11)