GATS trial
Phase 2
Completed
- Conditions
- Patients with CD20-positive non-Hodgkin's lymphoma (diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), marginal zone lymphoma (MZL))
- Registration Number
- JPRN-jRCT2080222796
- Lead Sponsor
- Chugai Pharmaceutical Co., Ltd.
- Brief Summary
Obinutuzumab given by SDI was well tolerated in Japanese patient
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 36
Inclusion Criteria
*Previously untreated CD20-positive B cell NHL (DLBCL,FL,MZL)
*Sufficient major organ function
*Performance status (PS) of 0-2
Exclusion Criteria
*History of severe allergic or anaphylactic reactions to test drug or its component
*Prior use of an anti-CD20 antibody
*Current or previous history of clinically significant disease
*Positive test results or known active viral infection including HBV,HCV,and HTLV-1
*Women who are pregnant, lactating. Women who get positive results from pregnancy tests.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>pharmacokinetics<br>Tolerability, Pharmacokinetics<br>Assessment and observations
- Secondary Outcome Measures
Name Time Method safety<br>efficacy<br>Safety, Anti-tumour activity<br>Assessment and observations