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

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).

Study Overview

• Status: Completed
• Conditions: Marginal Zone B-cell Lymphoma
• Intervention / Treatment: Drug: bendamustine plus rituximab

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.

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Anyang-si, Korea, Republic of
    • Hallym University Medical Center
  • Daejeon, Korea, Republic of
    • Chungnam National University
  • Incheon, Korea, Republic of
    • Gachon University Gil Medical Center
  • Jinju, Korea, Republic of
    • Gyeongsang National University Hospital
  • Seongnam, Korea, Republic of
    • Seoul National University Bundang Hospital
  • Seoul, Korea, Republic of
    • Seoul National University Hospital
  • Seoul, Korea, Republic of
    • Korea Cancer Center Hospital
  • Seoul, Korea, Republic of
    • Seoul National University Boramae Hospital
  • Seoul, Korea, Republic of
    • The Catholic University of Korea
  • Seoul, Korea, Republic of
    • Inje Universit
  • Jeollabuk-do
    • Jeonju, Jeollabuk-do, Korea, Republic of, 54907
      • Chonbuk National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Histologically confirmed CD20-positive nodal or extranodal MZBCL

2. 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
3. Patients age ≥ 18 years
4. ECOG PS 0-2
5. At least one bidimensionally measurable disease
6. Adequate hematologic, renal, and hepatic functions
7. Women of child-bearing potential should use two appropriate methods of contraception during the study
8. Written informed consent

Exclusion Criteria:

1. Not all of the above inclusion criteria are met.
2. Prior chemotherapy within 4 weeks or radiotherapy within 6 weeks
3. Corticosteroids during last 28 days except chronic administration of prednisolone at a dose of < 20mg/day for indications other than lymphomas
4. Evidence of CNS involvement by lymphomas
5. Active HBV/HCV infections, known HIV infection
6. Prior diagnosis of cancers within 5 years, except cervical intraepithelial neoplasia type 1, localized non-melanoma skin cancer, or small differentiated thyroid cancer
7. Serious concurrent disease:
8. Patients who are pregnant or lactating

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Bendamustine plus rituximab(BR); Intravenous bendamustine plus rituximab intravenously at 1st cycle and subcutaneously from 2nd cycle (to maximum 8th cycle).	Drug: bendamustine plus rituximab; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overall response rate based on Revised Response Criteria for Malignant Lymphoma	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Complete remission rate	6 months
Safety based on NCI CTCAE version 4.0	1 year

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (ACTUAL): October 1, 2019
• Study Completion (ACTUAL): October 1, 2019

Study Registration Dates

• First Submitted: April 5, 2015
• First Submitted That Met QC Criteria: May 4, 2015
• First Posted (ESTIMATE): May 5, 2015

Study Record Updates

• Last Update Posted (ACTUAL): September 24, 2021
• Last Update Submitted That Met QC Criteria: September 23, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Marginal zone B-cell lymphoma; bendamustine plus rituximab
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, B-Cell; Lymphoma, B-Cell, Marginal Zone; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antirheumatic Agents; Antineoplastic Agents; Immunologic Factors; Antineoplastic Agents, Alkylating; Alkylating Agents; Antineoplastic Agents, Immunological; Bendamustine Hydrochloride; Rituximab
• Other Study ID Numbers: LY14-09