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

Primary Purpose

Marginal Zone B-cell Lymphoma

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
bendamustine plus rituximab
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Marginal Zone B-cell Lymphoma focused on measuring Marginal zone B-cell lymphoma, bendamustine plus rituximab

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Bendamustine plus rituximab(BR)

Arm Description

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

Outcomes

Primary Outcome Measures

Overall response rate based on Revised Response Criteria for Malignant Lymphoma

Secondary Outcome Measures

Complete remission rate
Safety based on NCI CTCAE version 4.0

Full Information

First Posted
April 5, 2015
Last Updated
September 23, 2021
Sponsor
Seoul National University Hospital
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
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1. Study Identification

Unique Protocol Identification Number
NCT02433795
Brief Title
Bendamustine Plus Rituximab (BR) for Relapsed or Progressive Marginal Zone B-cell Lymphoma (MZBCL)
Official Title
A Phase II Study of Bendamustine Plus Rituximab (BR) in Patients With Relapsed or Progressive Marginal Zone B-cell Lymphoma (MZBCL)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
October 2019 (Actual)
Study Completion Date
October 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
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

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Marginal Zone B-cell Lymphoma
Keywords
Marginal zone B-cell lymphoma, bendamustine plus rituximab

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bendamustine plus rituximab(BR)
Arm Type
Experimental
Arm Description
Intravenous bendamustine plus rituximab intravenously at 1st cycle and subcutaneously from 2nd cycle (to maximum 8th cycle).
Intervention Type
Drug
Intervention Name(s)
bendamustine plus rituximab
Intervention Description
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 Outcome Measure Information:
Title
Overall response rate based on Revised Response Criteria for Malignant Lymphoma
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Complete remission rate
Time Frame
6 months
Title
Safety based on NCI CTCAE version 4.0
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dae Seog Heo, MD, PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chonbuk National University Hospital
City
Jeonju
State/Province
Jeollabuk-do
ZIP/Postal Code
54907
Country
Korea, Republic of
Facility Name
Hallym University Medical Center
City
Anyang-si
Country
Korea, Republic of
Facility Name
Chungnam National University
City
Daejeon
Country
Korea, Republic of
Facility Name
Gachon University Gil Medical Center
City
Incheon
Country
Korea, Republic of
Facility Name
Gyeongsang National University Hospital
City
Jinju
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
Country
Korea, Republic of
Facility Name
Inje Universit
City
Seoul
Country
Korea, Republic of
Facility Name
Korea Cancer Center Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul National University Boramae Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
The Catholic University of Korea
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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