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Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080222241
Enrollment
618
Registered
2013-10-02
Start date
2013-09-12
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

Follicular lymphoma

Interventions

investigational material(s) Generic name etc : GP2013 INN of investigational material : - Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material

Sponsors

Sandoz.K.K
Lead Sponsor
Novartis Pharma.K.K
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Inclusion Criteria: - Patient with previously untreated advanced stage, CD20-positive FL - >= 18 years old - Patient with ECOG performance status 0, 1 or 2.

Exclusion criteria

Exclusion criteria: Exclusion Criteria: - Patient who has previously received any prior therapy for lymphoma - Patient with evidence of any uncontrolled, active infection (viral, bacterial or fungal). - Patient with any malignancy within 5 years prior to date of randomization, with the exception of adequately treated in situ carcinoma of the cervix uteri, basal or squamous cell carcinoma or non-melanomatous skin cancer. - Other protocol-defined inclusion/exclusion criteria may apply

Design outcomes

Primary

MeasureTime frame
efficacy efficacy

Secondary

MeasureTime frame
safety efficacy pharmacokinetics efficacy, safety, pharmacokinetics

Countries

Japan

Outcome results

None listed

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