Indolent non Hodgkin'
Conditions
Interventions
The dosage and schedule of rituximab in this study is 375 mg/m2 x eight weekly infusions.
Sponsors
Zenyaku Kogyo Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.CD20 positive B-cell lymphoma confirmed by histopathological diagnosis. The expression of CD20 antigen on lymphoma cells to be confirmed by either immunohistochemistry or flow cytometry. 2.NHLs diagnosed as follows according to WHO classification by biopsy. 1)Small lymphocytic lymphoma 2)Lymphoplasmacytic lymphoma 3)Splenic marginal zone B-cell lymphoma 4)Extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue type 5)Nodal marginal zone B-cell lymphoma 6)Follicular lymphoma 3.Target lesion(s) for evaluation Patients with measurable lesion(s) meeting the following criteria defined by the Lymphoma Study Group of Japan Clinical Oncology Group according to the International Workshop Criteria. 1)Enlarged lympho node and/or mass, or extra nodal mass diagnosed as malignant lymphoma. 2)Presence of bi-dimensionally measurable disease lesion(s) confirmed on CT film. 3)The greatest diameter of the lesion longer than 1.5cm. 4.Patients who failed to respond to the prior chemotherapy or who relapsed after achieving clinically complete or partial response to the prior chemotherapy. 5.The last chemotherapy should have been completed at least four weeks prior to the entry 6.HBs antigen and HCV antibody must be negative serologically within four weeks prior to the entry. 7.Life expectancy > 2 months after the initial infusion. 8.Performance status < 2 on the Eastern Cooperative Oncology Group scale. 9.Ann Arbor clinical stage I-IV at the entry. 10.Age must be between 20 and 79 years old 11.Patients should have adequate organ function as follows: 1)Bone marrow function absolute neutrophil count>=1,200/uL platelet count>=75,000/uL 2)Hepatic function AST<4.0xNu ALT<4xNu TB<2.0xNu 3)Renal function serum creatinine<1.5xNu 4)Cardiopulmonary function PaO2>=65 mmHg 12.All patients are required to stay in hospital for at least two days after the first infusion of rituximab. 13.All patients who signed an informed consent form by him/herself for participating in this study.
Exclusion criteria
Exclusion criteria: 1. Prior treatment history 1)Patients who received rituximab within the past one year. 2)Previous treatment with a murine, chimeric or humanized MoAb other than rituximab 3)Patients with positive human anti-chimeric antibody (HACA) 4)Treatment with investigational new drugs under development at least six months prior to the entry into the study. 5)Previous treatment with hematopoietic growth factors such as granulocyte-colony stimulating factor (G-CSF) within one week prior to the entry. 2. Patients whose lymphoma cells in peripheral blood (PB) exceed 5,000/uL. 3. Concomitant and /or previous diseases 1)Seropositive for human immunodeficiency virus (HIV) antibody. 2)Patients with active hepatitis, ongoing infection and serious illness. 3)Patients with active concomitant malignancies. 4)Presence or history of CNS involvement, or patients with suspicion of CNS involvement. 5)Patients with serious mental disorder. 4. Pregnant or lactating women, women with positive of pregnancy test, or women of child bearing potential. 5. Patients who entered the other clinical studies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate (ORR) for eligible patients | — |
Secondary
| Measure | Time frame |
|---|---|
| 1."Progression free survival" for eligible patients and "Time to progression" for responder patients 2.frequency and severity of adverse events for all treated patients 3.pharmacokinetic parameters | — |
Countries
Japan
Contacts
Public ContactIzumi Okugaito
Zenyaku Kogyo Co., Ltd. Clinical development promotion section
Outcome results
None listed