Phase I study of RG7159 in CD20-positive B-cell non-Hodgkin's lymphoma
- Conditions
- non-Hodgkin's lymphoma
- Registration Number
- JPRN-jRCT2080221745
- Lead Sponsor
- Chugai Pharmaceutical Co., Ltd.
- Brief Summary
GA101 has an acceptable safety profile and offers encouraging activity to Japanese patients with relapsed/refractory B-cell non-Hodgkin lymphoma.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 12
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/d
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>Safety<br>CTCAE v3.0
- Secondary Outcome Measures
Name Time Method efficacy<br>pharmacokinetics<br>- Pharmacokinetics<br>- Pharmacodynamics<br>- Efficacy<br> - Response rate<br> - Complete remission rate<br><br>Standardize response criteria for non-Hodgkin's lymphomas