Non Hodgkin's Lymphoma
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - CD20 positive B cell NHL that is recurrent or refractory to standard therapy or for which no standard therapy exists. - Pathologically confirmed B cell NHL. - ECOG PS of 0 or 1. - Life expectancy =>12 weeks from the date of enrollment. - Major organ function meets all criteria.
Exclusion criteria
Exclusion criteria: - Pregnant or lactating woman. - Current or previous autoimmune disease. - Positive test result for human immunodeficiency virus antibody, hepatitis B surface antigen, HBs antibody, hepatitis B core antibody, or hepatitis C virus antibody. - Current or previous clinically significant liver disease. - Current central nervous system lymphoma, metastases to the CNS, or meningeal metastases. - History of previous therapy with allogenic hematopoietic stem cell transplantation or solid organ transplantation. - History of severe allergic or anaphylactic reactions to monoclonal antibody therapy or fusion proteins.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety pharmacokinetics other other(DLT) NCI CTCAE | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy pharmacokinetics other other (ADA) Revised Response Criteria for Malignant Lymphoma | — |
Countries
Japan