CD20 positive indolent B-cell non-Hodgkin lymphoma and mantle cell lymphoma
Conditions
Interventions
Rituximab 375mg/m2 on day 1, and bendamustine 90mg/m2 on day 1 and 2, or day 2 and 3. Repeated every 28 days for 6 cycles.
Sponsors
Kyoto University Hematology Study Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1, pathological diagnosis of indolent B-cell non-Hodgkin lymphoma or mantle cell lymphoma 2, relapsed or progressed after achieving response to prior chemotherapy, or resistant to prior chemotherapy. 3, CD20 positive disease 4, with assessable lesions 5, ECOG Performance Status of 0 to 2
Exclusion criteria
Exclusion criteria: 1, pregnant or breast-feeding women 2, patients with active second cancer 3, HBs antigen positive or HBV-DNA positive patients 4, HIV antibody positive patients 5, patients who have been treated with stem cell transplantation 6, interstitial pneumonitis or pulmonary fibrosis 7, patients with central nervous system involvement 8, patients who have already received bendamustine treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| 1, response rate 2, complete response rate 3, overall survival 4, event-free survival 5, proportion of patients completing 3 and 6 cycles of treatment 6, incidence of grade 3 and 4 adverse events 7, assessment of immunological parameters during and after treatment | — |
Countries
Japan
Contacts
Public ContactToshiyuki Kitano
Kyoto University Hospital Department of Hematology/Oncology
Outcome results
None listed