Clinical trial NCT02433795: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Marginal Zone B-cell Lymphoma
Keywords: Marginal zone B-cell lymphoma
bendamustine plus rituximab
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Gyeongsang National University Hospital
name: Korea Cancer Center Hospital
name: Seoul National University Boramae Hospital
name: Hallym University Medical Center
name: Inje University
name: Gangnam Severance Hospital
name: Chonbuk National University Hospital
name: Chungnam National University
name: The Catholic University of Korea
name: Wonju Severance Christian Hospital
name: Gachon University Gil Medical Center
name: Seoul National University Bundang Hospital
First posted: 2015-05-05
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Overall response rate based on Revised Response Criteria for Malignant Lymphoma
timeFrame: 6 months
Secondary outcomes:
measure: Complete remission rate
timeFrame: 6 months
measure: Safety based on NCI CTCAE version 4.0
timeFrame: 1 year
Other outcomes:
Locations:
city: Jeonju
country: Korea, Republic of
facility: Chonbuk National University Hospital
state: Jeollabuk-do
city: Anyang-si
country: Korea, Republic of
facility: Hallym University Medical Center
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
city: Jinju
country: Korea, Republic of
facility: Gyeongsang National University Hospital
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Inje Universit
city: Seoul
country: Korea, Republic of
facility: Korea Cancer Center Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Boramae Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea
Study officials:
affiliation: Seoul National University Hospital
name: Dae Seog Heo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: