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GATS trial

A phase II study with CD20-positive non-Hodgkin's lymphoma treated with shorter duration of infusion of GA101(RO5072759)

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080222796
Enrollment
36
Registered
2015-03-17
Start date
2015-04-03
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with CD20-positive non-Hodgkin's lymphoma (diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), marginal zone lymphoma (MZL))

Interventions

investigational material(s) Generic name etc : Obinutuzumab (RO5072759/GA101) INN of investigational material : Obinutuzumab Therapeutic category code : 429 Other antitumor agents Dosage and Administr

Sponsors

Chugai Pharmaceutical Co., Ltd.
Lead Sponsor
Nippon Shinyaku Co., Ltd.
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: *Previously untreated CD20-positive B cell NHL (DLBCL,FL,MZL) *Sufficient major organ function *Performance status (PS) of 0-2

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
safety pharmacokinetics Tolerability, Pharmacokinetics Assessment and observations

Secondary

MeasureTime frame
safety efficacy Safety, Anti-tumour activity Assessment and observations

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026