Marginal Zone B-cell Lymphoma
Conditions
Keywords
Marginal zone B-cell lymphoma, bendamustine plus rituximab
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.
Interventions
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
Sponsors
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
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rate | Up to disease progression, more than 30.12 months | Overall Response Rate (ORR) is defined as the proportion of patients with a confirmed Complete Response (CR) or Partial Response (PR) as assessed by the investigator. And ORR is based on Revised Response Criteria for Malignant Lymphoma |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Survival | Up to disease progression, more than 30.12 months | Progression-Free Survival (PFS) rate is defined as the proportion of patients who are alive and have not experienced disease progression at a specified time point and is defined from the date of first dose (or randomization) to the earliest date of objective disease progression or death from any cause, whichever occurs first. |
| The 3-year Survival Rate | From the 1st date of IP administration to the date of death | The 3-year survival rate is defined as the proportion of patients alive at 3 years from the date of first dose, estimated using the Kaplan-Meier method. And it was calculated at the point of data cut-off. |
Countries
South Korea
Contacts
PRINCIPAL_INVESTIGATORDae Seog Heo, MD, PhD
Seoul National University Hospital
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 66 year |
| Ann Arbor stage Ⅱ | 4 Participants |
| Ann Arbor stage Ⅲ | 2 Participants |
| Ann Arbor stage Ⅳ | 21 Participants |
| ECOG performance status ECOG PS 0-1 | 26 Participants |
| ECOG performance status ECOG PS 2 | 1 Participants |
| International Prognostic Index High-intermediate risk | 9 Participants |
| International Prognostic Index High risk | 2 Participants |
| International Prognostic Index Low-intermediate risk | 12 Participants |
| International Prognostic Index Low risk | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 27 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 14 Participants |
| Subtype Extranodal mariginal zone lymphome (EMZL) | 14 Participants |
| Subtype Nodal mariginal zone lymphome (NMZL) | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 27 |
| other Total, other adverse events | 14 / 27 |
| serious Total, serious adverse events | 3 / 27 |
Outcome results
None listed