non-Hodgkin's lymphoma
Conditions
Interventions
investigational material(s)
Generic name etc : RG7159
INN of investigational material : obinutuzumab
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigationa
Sponsors
Chugai Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Has had details of the clinical trial explained thoroughly to him/her and has personally given informed consent in writing. - Diagnosed histologically with malignant lymphoma, this being B-cell non-Hodgkin's lymphoma confirmed as CD20+ by flow cytometry or immunohistochemistry, for which no treatment of higher priority is available. - Relapsed or refractory disease to treatment including rituximab. - Presence of at least one measurable lesion (bidimensionally measurable at right angles by CT scan, with the largest tumor dimension exceeding 1.5 cm) - Aged fully 20 to less than 75 years at the time of informed consent. - ECOG Performance Status of 0 or 1. - Judged to have life expectancy of at least 12 weeks from the date of enrollment. - Major organ function meeting the following criteria in the 2 week period before enrollment. - Creatinine clearance (Cockcroft-Gault formula): Exceeding 50 mL/min - AST, ALT: Not more than 2.5 times the upper limit of normal - Platelets: > 7.5x104/mm3 - Neutrophils: > 1.5x103/mm3 - Hemoglobin: > 10 g/dL
Exclusion criteria
Exclusion criteria: - Prior use of any investigational monoclonal antibody therapy less than 24 weeks before enrollment, or prior use of any other investigational product less than 4 weeks before enrollment, - Prior use of rituximab less than 8 weeks before enrollment, or received any radioimmunotherapy less than 12 weeks before enrollment. - Chemotherapy or radiotherapy less than 4 weeks before enrollment. - Presence of other cancers with disease-free period of less than 5 years (excluding patients with a history of cured basal cell carcinoma or cervical epithelial carcinoma). - Serious heart disease. - Symptomatic bronchospasm (including a history thereof), obstructive pulmonary disease or any pulmonary disease requiring treatment. - Positive for HIV antigen, HIV antibody, HBs antigen, HBc antibody, HBV-DNA, or HCV antibody. - Tumor burden exceeding 25,000/mm3.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety Safety CTCAE v3.0 | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy pharmacokinetics - Pharmacokinetics - Pharmacodynamics - Efficacy - Response rate - Complete remission rate Standardize response criteria for non-Hodgkin's lymphomas | — |
Countries
Japan
Outcome results
None listed