relapsed or refractory indolent B-cell non-Hodgkin lymphoma and mantle cell lymphoma
Conditions
Interventions
Bendamustine+Rituximab Phase 1 Rituximab Day1 375mg/m2/day Bendamustine Day2, Day3 Level 1: 90mg/m2/day, every 21 days Level 2: 90mg/m2/day, every 28 days Level 3: 120mg/m2/day, every 21 days
Sponsors
Department of Hematology, International Medical Center, Saitama Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Patients with pathologically confirmed indolent B-cell non-Hodgkin lymphoma or mantle cell lymphoma. (2) Patients had received prior treatment of rituximab in combination with chemotherapy (without corticosteroid alone) or antibody treatments that rituximab alone or ibritumomab tiuxetan, and were considered no response or relapse after CR or PR. (3) CD20 positive (4) Patients have measurable lesion that measured >=1.5cm in a single dimension by CT. (5) Patients aged 20-74 years. (6) PS(ECOG) 0-2 (7) Patients meet all following standard Absolute neutrophil count >= 1,500/mm3 Platelet count >= 100,000/mm3 AST and ALT < 2.5 times facility criteria. Total bilirubin < 1.5 times facility criteria. Creatinine < 1.5 times facility criteria. Cardiac electro gram: no abnormality required treatment SpO2: >= 90% (8) Patients have a life expectancy > 3 months. (9) Written informed consent.
Exclusion criteria
Exclusion criteria: (1) Patients are pregnant or lactating women. Patients (<1 year after menopause without surgical infertility) can not or will not use birth control during the treatment (2) Patients have active other malignant diseases including simultaneous cancer and disease free state within 5 years after treatment for other cancer except curable intramural cancer by local treatment. (3) Patients have mental disease or disorder with difficulty in participating in the clinical trial. (4) HBs antigen positive (5) HCV antibody positive (6) HIV antibody positive (7) Patients have much tumor cell in peripheral blood (>=25,000/mm3). (8) Patients received allogeneic hematopoietic (hemopoietic) stem cell transplant. (9) Patients have interstitial lung disease or fibroid lung. (10) Patients have CNS invasion. (11) Patients already received bendamustine treatment. (12) Patients are inappropriate for rituximab treatment. (13) Patients have severe allergic symptoms. (14) Inadequate for clinical trial entry by the attending physicians.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase 1 recommended dose dose limiting toxicity maximum tolerated dose overall response rate Phase 2 overall response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase 1 overall response rate Phase 2 complete response rate progression-free survival safty | — |
Countries
Japan
Contacts
Public ContactNaoki Takahashi
International Medical Center, Saitama Medical University Department of Hematology
Outcome results
None listed