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

Phase 2

Completed

• Conditions: Marginal Zone B-cell Lymphoma
• Interventions: Drug: bendamustine plus rituximab

• Registration Number: NCT02433795
• Lead Sponsor: Seoul National University Hospital

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.

Study Timeline

• Study First Submitted: 2015-04-05
• Study Start: 2015-05
• Study First Submitted QC: 2015-05-04
• Study First Posted: 2015-05-05
• Primary Completion: 2019-10
• Study Completion: 2019-10
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-23
• Last Update Posted: 2021-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Overall response rate based on Revised Response Criteria for Malignant Lymphoma	6 months

Secondary Outcome Measures

Name	Time	Method
Safety based on NCI CTCAE version 4.0	1 year
Complete remission rate	6 months

Trial Locations

Locations (11)

Chonbuk National University Hospital; 🇰🇷 Jeonju, Jeollabuk-do, Korea, Republic of

Hallym University Medical Center; 🇰🇷 Anyang-si, Korea, Republic of

Chungnam National University; 🇰🇷 Daejeon, Korea, Republic of

Gachon University Gil Medical Center; 🇰🇷 Incheon, Korea, Republic of

Korea Cancer Center Hospital; 🇰🇷 Seoul, Korea, Republic of

Seoul National University Boramae Hospital; 🇰🇷 Seoul, Korea, Republic of

Seoul National University Bundang Hospital; 🇰🇷 Seongnam, Korea, Republic of

Inje Universit; 🇰🇷 Seoul, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of

Gyeongsang National University Hospital; 🇰🇷 Jinju, Korea, Republic of

The Catholic University of Korea; 🇰🇷 Seoul, Korea, Republic of