NCT01414855 - A Study of Obinutuzumab [RO5072759 (GA101)] in Combination With CHOP Chemotherapy in Patients With Previously Untreated Advanced Diffuse Large B-Cell Lymphoma (GATHER) | Crick

Outcomes

Primary Outcomes

Complete Response (CR) Rate as Assessed by the Investigator at the End of Treatment

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.

Time frame: From the first dose of study treatment to end of treatment response assessment (approximately 228 to 258 days)

Overall Response Rate (ORR) as Assessed by the Investigator at the End of Treatment

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.

Time frame: From the first dose of study treatment to end of treatment response assessment (approximately 228 to 258 days)

Secondary Outcomes

Complete Response (CR) Rate as Assessed by the Independent Review Facility (IRF) at the End of Treatment

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.

Time frame: From the first dose of study treatment to end of treatment response assessment (approximately 228 to 258 days)

Overall Response Rate (ORR) as Assessed by the IRF at the End of Treatment

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.

Time frame: From the first dose of study treatment to end of treatment response assessment (approximately 228 to 258 days)

Progression-Free Survival (PFS) as Assessed by the Investigator

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.

Time frame: From the first dose of study treatment to PFS assessment (up to 64 months)

Duration of Response (DOR)

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.

Time frame: From the response assessment to relapse, progression, or death (up to 64 months)

Percentage of Participants With Adverse Events as a Measure of Safety

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.

Time frame: From the first dose of study treatment to end of study (up to 5 years 4 months)

Number of Participants With Grade 3 to 4 Infusion-Related (IRR) Adverse Events (AE) in Participants Receiving Shorter Duration Infusion (SDI)

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.

Time frame: From the first dose of study treatment to end of treatment response assessment (approximately 228 to 258 days)

Pharmacokinetics (PK): Maximum Concentration Observed (Cmax) for Obinutuzumab

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).