low-grade B cell non-Hodgkin lymphoma, Mantle cell lymphoma
Conditions
Interventions
bendamustine monotherapy or bendamustine/rituximab therapy will be administered
Sponsors
KEIO BRB Study Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients who have been diagnosed as histologically confirmed low-grade B cell non-Hodgkin's lymphoma or mantle cell lymphoma 2. Patients who have received bendamustine containing chemothrapy 3. Patients who have maintained reponse(greater than PR) to previous bendamustine containing regimen for over 3 months 4. Patients with measurable disease 5. Patients over 20 years-old 6. ECOG PS of 0 - 2 7. Patients who fulfill the following criteria ANC > 1,000 /mm3 Hgb > 8.0g /dL Plt > 75,000 /mm3 AST, ALT < x2.5 ULN T-Bil <2.0 mg/dl Cr <2.0 mg/dl 8. Patients with a life expectancy of > 3 months 9. Patients who can give written informed consent to the study
Exclusion criteria
Exclusion criteria: 1. patients who are pregnant/female patients who are unwilling to take prevention measures for contraception during treatment 2. patients with active cancer 3. patients wih mental illnesses that the treating physician judges difficult to participate in the study 4. patients with circulating tumor cells > 25,000 /uL 5. patients with severe allergic reaction to medication 6. patients with active infectious diseases 7. patients who are positive for HBs antigen or HBV-DNA 8. patients who are judged inadequate to participate in the study according to the treating physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate after 2 cycles of thearpy | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Best overall response rate 2. complete response rate 3. progression free survival 4. safety 5. safety and efficacy after each cycle of treatment | — |
Countries
Japan
Contacts
Public ContactKoichi Murakami
Keio University School of Medicine Division of Hematology
Outcome results
None listed