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

• Sponsor: Seoul National University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02433795
• Collaborator: Gyeongsang National University Hospital (Other), Korea Cancer Center Hospital (Other), Seoul National University Boramae Hospital (Other), Hallym University Medical Center (Other), Inje University (Other), Gangnam Severance Hospital (Other), Chonbuk National University Hospital (Other), Chungnam National University (Other), The Catholic University of Korea (Other), Wonju Severance Christian Hospital (Other), Gachon University Gil Medical Center (Other), Seoul National University Bundang Hospital (Other)
• Enrollment: 27
• Locations: 11
• Arm: 1
• Duration (Months): 53
• Patients Per Site: 2.5
• Patients Per Site Per Month: 0

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Marginal Zone B-cell Lymphoma	Drug: bendamustine plus rituximab	Phase 2

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 Design

• Study Type: Interventional
• Actual Enrollment: 27 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase II Study of Bendamustine Plus Rituximab (BR) in Patients With Relapsed or Progressive Marginal Zone B-cell Lymphoma (MZBCL)
• Study Start Date: May 1, 2015
• Actual Primary Completion Date: Oct 1, 2019
• Actual Study Completion Date: Oct 1, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Overall response rate based on Revised Response Criteria for Malignant Lymphoma [6 months]

Secondary Outcome Measures

1. Complete remission rate [6 months]

2. Safety based on NCI CTCAE version 4.0 [1 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

1. Patients age ≥ 18 years

2. ECOG PS 0-2

3. At least one bidimensionally measurable disease

4. Adequate hematologic, renal, and hepatic functions

5. Women of child-bearing potential should use two appropriate methods of contraception during the study

6. 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chonbuk National University Hospital	Jeonju	Jeollabuk-do	Korea, Republic of	54907
2	Hallym University Medical Center	Anyang-si		Korea, Republic of
3	Chungnam National University	Daejeon		Korea, Republic of
4	Gachon University Gil Medical Center	Incheon		Korea, Republic of
5	Gyeongsang National University Hospital	Jinju		Korea, Republic of
6	Seoul National University Bundang Hospital	Seongnam		Korea, Republic of
7	Inje Universit	Seoul		Korea, Republic of
8	Korea Cancer Center Hospital	Seoul		Korea, Republic of
9	Seoul National University Boramae Hospital	Seoul		Korea, Republic of
10	Seoul National University Hospital	Seoul		Korea, Republic of
11	The Catholic University of Korea	Seoul		Korea, Republic of

Sponsors and Collaborators

• Seoul National University Hospital
• 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

Investigators

• Principal Investigator: Dae Seog Heo, MD, PhD, Seoul National University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Tae Min Kim, Professor, Seoul National University Hospital
• ClinicalTrials.gov Identifier: NCT02433795
• Other Study ID Numbers: LY14-09
• First Posted: May 5, 2015
• Last Update Posted: Sep 24, 2021
• Last Verified: Sep 1, 2021

• Keywords provided by Tae Min Kim, Professor, Seoul National University Hospital: Marginal zone B-cell lymphoma; bendamustine plus rituximab
• Additional relevant MeSH terms: Lymphoma; Lymphoma, B-Cell; Lymphoma, B-Cell, Marginal Zone; Rituximab; Bendamustine Hydrochloride

Study Results

No Results Posted as of Sep 24, 2021