relapsed/refractory indolent B-cell lymphomas and mantle cell lymphomas
Conditions
Interventions
rituximab 375 mg/m2 (Day1)+bendamustine 90 mg/m2 (Day1, Day2) Typically, courses are administered at an interval of 28 days (a maximum of 6 cycles).
Sponsors
B-SRIM 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. Typically, a re-biopsy is required for histological diagnosis at the time of a recurrence. 2. Patients who have received bendamustine containing chemotherapy 3. Patients who have maintained response (greater than PR) to the last bendamustine containing regimen for over 6 months 4. Patients who have at least one measurable disease (> 1.5cm diameter) with CT scanning 5. Patients over 20 years old and less than 85 years old (at the registration) 6. Patients whose performance status are 0-2 by ECOG criteria 7. Patients who meet all of the following condition Neutrophil >= 1,000 /mm3 Hb >= 8.0g /dL Plt >= 75,000 /mm3 AST, ALT < x 2.5 ULN T-Bil =< 2.0 mg/dl Cr =< 2.0 mg/dl 8. Patients who are evaluated to survive more than three months 9. Patients who give written informed consent following sufficient explanation.
Exclusion criteria
Exclusion criteria: 1. Patients who are pregnant or in the location period, and who are not able to, or not willing to prevent conception during the therapeutic period of this clinical study 2. Patients who have coinciding active cancer 3. Patients who have psychiatric disorder 4. Patients who have circulating lymphoma cells >= 25,000 /uL in peripheral blood 5. Patients who have interstitial pneumonia or pulmonary fibrosis 6. Patients who have central nerve system lymphoma 7. Patients who have severe allergic reaction to medication 8. Patients who are considered as inappropriate to register by physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall response rate (ORR) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. complete response rate (CRR) 2. progression free survival (PFS) 3. safety 4. evaluation of efficacy and safety for each regimens | — |
Countries
Japan
Contacts
Public ContactShinichi Kobayashi
National Defense Medical College Division of Hematology
Outcome results
None listed