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NCT Number: NCT02433795

Bendamustine Plus Rituximab (BR) for 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).

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Chonbuk National University Hospital, Jeonju, Jeollabuk-do, South Korea

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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

Primary outcomes

  1. Overall Response Rate

    Time frame: Up to disease progression, more than 30.12 months

    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

Secondary outcomes

  1. Progression-free Survival

    Time frame: 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.

  2. The 3-year Survival Rate

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

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

Registry information

Official study title

A Phase II Study of Bendamustine Plus Rituximab (BR) in Patients With Relapsed or Progressive Marginal Zone B-cell Lymphoma (MZBCL)

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
May 5, 2015
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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