A Study of Obinutuzumab [RO5072759 (GA101)] in Combination With CHOP Chemotherapy in Patients With Previously Untreated Advanced Diffuse Large B-Cell Lymphoma (GATHER)
CompletedPhase 2Results postedLast updated 25 April 2018
What this trial tests
Phase 2 trial testing obinutuzumab in Lymphoma, B-Cell in 100 participants. Completed in 23 December 2016.
18 and older, any sex, with Lymphoma, B-Cell. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Complete Response (CR) Rate as Assessed by the Investigator at the End of TreatmentPrimary· From the first dose of study treatment to end of treatment response assessment (approximately 228 to 258 days)
Complete response rate is defined as the percentage of participants with Complete Response (CR) according to the Revised Response Criteria for Malignant Lymphoma (Cheson et al., 2007). Disease response was evaluated by the investigator using regular clinical and laboratory examinations, fluorodeoxyglucose-positron emission tomography (FDG-PET) and computed tomography (CT). CR is the disappearance of all evidence of disease.
Group
Value
95% CI
Obinutuzumab + CHOP
55.0
44.73 – 64.97
Overall Response Rate (ORR) as Assessed by the Investigator at the End of TreatmentPrimary· From the first dose of study treatment to end of treatment response assessment (approximately 228 to 258 days)
Overall response rate was defined as the percentage of participants with Complete Response (CR) or Partial Response (PR) according to the Revised Response Criteria for Malignant Lymphoma (Cheson et al., 2007). Disease response was evaluated by the investigator using regular clinical and laboratory examinations, FDG-PET and computed tomography (CT). CR is the disappearance of all evidence of disease. PR is at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites.
Group
Value
95% CI
Obinutuzumab + CHOP
82.0
73.05 – 88.97
Complete Response (CR) Rate as Assessed by the Independent Review Facility (IRF) at the End of TreatmentSecondary· From the first dose of study treatment to end of treatment response assessment (approximately 228 to 258 days)
Complete response rate is defined as the percentage of participants with Complete Response (CR) according to the Revised Response Criteria for Malignant Lymphoma (Cheson et al., 2007). Disease response was evaluated by the IRF using CT scans, PET scans and pertinent clinical information. CR is the disappearance of all evidence of disease.
Group
Value
95% CI
Obinutuzumab + CHOP
58.0
47.71 – 67.80
Overall Response Rate (ORR) as Assessed by the IRF at the End of TreatmentSecondary· From the first dose of study treatment to end of treatment response assessment (approximately 228 to 258 days)
Overall response rate was defined as the percentage of participants with Complete Response (CR) or Partial Response (PR) according to the Revised Response Criteria for Malignant Lymphoma (Cheson et al., 2007). Disease response was evaluated by the IRF using CT scans, PET scans and pertinent clinical information. CR is the disappearance of all evidence of disease. PR is at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites.
Group
Value
95% CI
Obinutuzumab + CHOP
75.0
65.34 – 83.12
Progression-Free Survival (PFS) as Assessed by the InvestigatorSecondary· From the first dose of study treatment to PFS assessment (up to 64 months)
PFS was defined as the time from the date of the first dose of study treatment until the date of disease progression, relapse, or death from any cause.
Group
Value
95% CI
Obinutuzumab + CHOP
48.3
46.1 – 58.2
Duration of Response (DOR)Secondary· From the response assessment to relapse, progression, or death (up to 64 months)
DOR is defined as first occurrence of documented response (CR or PR) until the first occurrence of relapse or progression or death of any cause. CR: disappearance of all evidence of disease. PR: at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites.
Group
Value
95% CI
Obinutuzumab + CHOP
45.6
43.1 – 55.7
Percentage of Participants With Adverse Events as a Measure of SafetySecondary· From the first dose of study treatment to end of study (up to 5 years 4 months)
An adverse event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug or other protocol-imposed intervention. Preexisting conditions that worsened during the study were reported as adverse events.
Group
Value
95% CI
Obinutuzumab + CHOP
100.0
Number of Participants With Grade 3 to 4 Infusion-Related (IRR) Adverse Events (AE) in Participants Receiving Shorter Duration Infusion (SDI)Secondary· From the first dose of study treatment to end of treatment response assessment (approximately 228 to 258 days)
SDI 120 is a shorter duration infusion of 120 minutes and SDI 90 is shorter duration infusion of 90 minutes. Grade 3 IRR AE: Prolonged (e.g., not rapidly responsive to symptomatic medication and/or brief interruption of infusion); recurrence of symptoms following initial improvement; hospitalization indicated for clinical sequelae. Grade 4 IRR AE: Life-threatening consequences; urgent intervention indicated.
SDI 120 (n=5)
Group
Value
95% CI
Obinutuzumab + CHOP
0
SDI 90 (n=70)
Group
Value
95% CI
Obinutuzumab + CHOP
0
Pharmacokinetics (PK): Maximum Concentration Observed (Cmax) for ObinutuzumabSecondary· Cycle 1 Day 1 pre and post dose, Days 3,5, Day 8 pre and post-dose, Day 15 pre-dose. Cycle 8 Day 1 pre and post-dose, Days 5,8,12
Blood was collected for PK Parameters. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA) measured in micrograms per milliliter (μg/mL).
Cycle 1
Group
Value
95% CI
Obinutuzumab + CHOP
297
± 110
Cycle 8 (n = 85)
Group
Value
95% CI
Obinutuzumab + CHOP
574
± 183
Pharmacokinetics: Terminal Half-Life (t1/2) for ObinutuzumabSecondary· Cycle 1 Day 1 pre and post dose, Days 3,5, Day 8 pre and post-dose, Day 15 pre-dose. Cycle 8 Day 1 pre and post-dose, Days 5,8,12
T1/2 is the time required for the concentration of the drug to reach half of its original value. Blood was collected for PK Parameters. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA) measured in days
Cycle 1 (n = 37)
Group
Value
95% CI
Obinutuzumab + CHOP
6.04
± 1.54
Cycle 8 (n = 21)
Group
Value
95% CI
Obinutuzumab + CHOP
23
± 15.9
Pharmacokinetics: Clearance (Cl) for ObinutuzumabSecondary· Cycle 1 Day 1 pre and post dose, Days 3,5, Day 8 pre and post-dose, Day 15 pre-dose. Cycle 8 Day 1 pre and post-dose, Days 5,8,12
Cl is the volume of serum cleared of the drug per unit of time. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA) measured in milliliters/day (mL/day).
Cycle 1 (n = 54)
Group
Value
95% CI
Obinutuzumab + CHOP
456
± 254
Cycle 8 (n = 37)
Group
Value
95% CI
Obinutuzumab + CHOP
143
± 59.8
Pharmacokinetics: Volume of Distribution (V) for ObinutuzumabSecondary· Cycle 1 Day 1 pre and post dose, Days 3,5, Day 8 pre and post-dose, Day 15 pre-dose. Cycle 8 Day 1 pre and post-dose, Days 5,8,12
V is the apparent volume in which a drug is distributed in the body. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA) measured in milliliters (mL).
Cycle 1 (n = 54)
Group
Value
95% CI
Obinutuzumab + CHOP
4580
± 2450
Cycle 8 (n = 37)
Group
Value
95% CI
Obinutuzumab + CHOP
9210
± 17000
Adverse events — posted to ClinicalTrials.gov
Time frame: From the first dose of study treatment to clinical data cut-off: 23 December 2016 (up to 5 years, 4 months).
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This open-label, multicenter study will evaluate the efficacy and safety of obinutuzumab \[RO5072759 (GA101)\] in combination with CHOP (Cyclophosphamide, Doxorubicin, Vincristine, Prednisone) chemotherapy in patients with advanced diffuse large B-cell lymphoma. Patients will receive 8 cycles of obinutuzumab (1000 mg intravenously on Day 1 of each 21-day cycle, during Cycle 1 obinutuzumab will also be infused on Days 8 and 15) in combination with CHOP chemotherapy on Day 1 of cycles 1 to 6. A substudy will investigate the drug-drug interaction of obinutuzumab with CHOP chemotherapy agents. For the substudy, an additional cohort of approximately 15 patients are planned to be enrolled at a subset of investigational sites.
Publications & conference data
6 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Genentech, Inc.
Last refreshed: 25 April 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01414855.