A Phase III, multicenter, Open - label, randomized trial in previously untreated patient with CD20-positive diffuse large B-cell lymphoma (DLBCL)

A Phase III, multicenter, open-label, randomized trial comparing the efficacy of GA101 (RG7159)in combination with CHOP (G-CHOP) versus Rituximab and CHOP (R-CHOP) in previously untreated patients with CD20-positive diffuse large B-cell lymphoma (DLBCL)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080221618

Enrollment

1418

Registered

2011-10-13

Start date

2011-07-26

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

Previously untreated patients with CD20-positive diffuse large B-cell lymphoma (DLBCL)

Interventions

investigational material(s) Generic name etc : GA101(Obinutuzumab) + CHOP INN of investigational material : Obinutuzumab Therapeutic category code : 429 Other antitumor agents Dosage and Administratio

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Adult patients, >/= 18 years of age - Previously untreated CD20-positive diffuse large B-cell lymphoma (DLBCL) - At least 1 bi-dimensionally measurable lesion (>1.5 cm in is largest dimension on the CT scan) - Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2 - Adequate hematological function

Exclusion criteria

Exclusion criteria: - History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products - Contraindication to any of the individual components of CHOP, including prior receipt of anthracyclines - Diagnosis of transformed lymphoma (follicular IIIB) if previously treated with radiotherapy, chemotherapy, or immunotherapy - Prior therapy for DLBCL, with the exception of nodal biopsy or local irradiation - Prior treatment with cytotoxic drugs or rituximab for another condition (e.g., rheumatoid arthritis) or prior use of an anti-CD20 antibody - Prior use of any monoclonal antibody within 3 months of the start of Cycle 1 - Ongoing corticosteroid use of > 30 mg/day of prednisone or equivalent - Primary CNS lymphoma, blastic variant of mantle-cell lymphoma, or histologic evidence of transformation to a Burkitt lymphoma, primary mediastinal DLBCL, primary effusion lymphoma, and primary cutaneous DLBCL

Design outcomes

Primary

Measure	Time frame
efficacy Progression-free survival, assessed by the investigator according to a modified version of the Revised Response Criteria for Malignant Lymphoma Modified Revised Response Criteria for Malignant Lymphoma	—

Secondary

Measure	Time frame
efficacy pharmacokinetics safety - Overall survival - Overall response rate at the end of treatment, assessed by the investigator and the Independent Review Committee (IRC) - Complete response rate at theend of treatment, assessed by investigator and IRC - Progression-free survival assessed by the Independent Review Committee - Event-free survival, defined as time to progression or relapse, or initiation of non-protocol-specified anti-lymphoma therapy, or death, whichever occurs first ,assessed by investigator - Disease-free survival, assessed by investigator - Duration of response, assessed by the investigator - Time to next lymphoma treatment - Safety: Incidence of adverse events - Quality of life (Functional Assessment of Cancer Therapy-Lymphoma subscale, Euro-Quality of Life 5D questionnaire, European Organization for Research and Treatment of Cancer Quality of Life Core 30) - Medical resource utilization (hospitalizations, drug therapies, medical and surgical procedures and treatments) - To characterize the pharmacokinetics of GA101 in combination with CHOP in Japanese patients Modified Revised Response Criteria for Malignant Lymphoma, CTCAE (v4)	—

Measure

Time frame

efficacy pharmacokinetics safety - Overall survival - Overall response rate at the end of treatment, assessed by the investigator and the Independent Review Committee (IRC) - Complete response rate at theend of treatment, assessed by investigator and IRC - Progression-free survival assessed by the Independent Review Committee - Event-free survival, defined as time to progression or relapse, or initiation of non-protocol-specified anti-lymphoma therapy, or death, whichever occurs first ,assessed by investigator - Disease-free survival, assessed by investigator - Duration of response, assessed by the investigator - Time to next lymphoma treatment - Safety: Incidence of adverse events - Quality of life (Functional Assessment of Cancer Therapy-Lymphoma subscale, Euro-Quality of Life 5D questionnaire, European Organization for Research and Treatment of Cancer Quality of Life Core 30) - Medical resource utilization (hospitalizations, drug therapies, medical and surgical procedures and treatments) - To characterize the pharmacokinetics of GA101 in combination with CHOP in Japanese patients Modified Revised Response Criteria for Malignant Lymphoma, CTCAE (v4)

—

Countries

Africa, Asia except Japan, Europe, Japan, North America, Oceania, South America

Outcome results

None listed

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