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

• ClinicalTrials.gov Identifier: NCT02433795
• Recruitment Status: Completed
• First Posted: May 5, 2015
• Last Update Posted: December 3, 2020
• 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
• Information provided by (Responsible Party): Tae Min Kim, Seoul National University Hospital

Tracking Information

• First Submitted Date: April 5, 2015
• First Posted Date: May 5, 2015
• Last Update Posted Date: December 3, 2020
• Study Start Date: May 2015
• Actual Primary Completion Date: October 2019 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: May 4, 2015): Overall response rate based on Revised Response Criteria for Malignant Lymphoma [ Time Frame: 6 months ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: May 4, 2015)

• Complete remission rate [ Time Frame: 6 months ]
• Safety based on NCI CTCAE version 4.0 [ Time Frame: 1 year ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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)
• 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 Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Marginal Zone B-cell Lymphoma

Intervention

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

Study Arms

Experimental: Bendamustine plus rituximab(BR)

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

Intervention: Drug: bendamustine plus rituximab

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 20, 2018): 27
• Original Estimated Enrollment (submitted: May 4, 2015): 39
• Actual Study Completion Date: October 2019
• Actual Primary Completion Date: October 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Korea, Republic of

Administrative Information

• NCT Number: NCT02433795
• Other Study ID Numbers: LY14-09
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Tae Min Kim, Seoul National University Hospital
• Study 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

Investigators

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

• PRS Account: Seoul National University Hospital
• Verification Date: December 2020