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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| obinutuzumab + CHOP | Experimental | Participants received 1000 mg obinutuzumab intravenously on Day 1 of each 21-day cycle for 8 cycles; during Cycle 1 administration also on Days 8 and 15. Participants also received standard CHOP therapy (cyclophosphamide, doxorubicin, vincristine and prednisone) for 6 cycles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| obinutuzumab | Drug | 1000 mg intravenously on Day 1 of each 21-day cycle, 8 cycles; during Cycle 1 administration also on Days 8 and 15. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | From the first dose of study treatment to end of treatment response assessment (approximately 228 to 258 days) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Genentech, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294-3300 | United States | ||
| cCare |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31050355 | Derived | Gibiansky E, Gibiansky L, Buchheit V, Frey N, Brewster M, Fingerle-Rowson G, Jamois C. Pharmacokinetics, exposure, efficacy and safety of obinutuzumab in rituximab-refractory follicular lymphoma patients in the GADOLIN phase III study. Br J Clin Pharmacol. 2019 Sep;85(9):1935-1945. doi: 10.1111/bcp.13974. Epub 2019 Jul 12. | |
| 30277102 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Obinutuzumab + CHOP | Participants received 1000 mg obinutuzumab intravenously on Day 1 of each 21-day cycle for 8 cycles; during Cycle 1 administration also on Days 8 and 15. Participants also received standard CHOP therapy (cyclophosphamide, doxorubicin, vincristine and prednisone) for 6 cycles. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| cyclophosphamide | Drug | 750 mg/m^2 intravenous (IV), Day 1 of each 21-day cycle, 6 cycles. |
|
| doxorubicin | Drug | 50 mg/m^2 IV, Day 1 of each 21-cycle, 6 cycles. |
|
| prednisone | Drug | 100 mg/day, Days 1 through 5 of each 21-day cycle, 6 cycles. |
|
| vincristine | Drug | 1.4 mg/m^2 IV, Day 1 of each 21-day cycle, 6 cycles. |
|
| 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. | 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. | 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. | 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. | 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. | 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). | 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 |
| Pharmacokinetics: Terminal Half-Life (t1/2) for Obinutuzumab | 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 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 |
| Pharmacokinetics: Clearance (Cl) for Obinutuzumab | 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 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 |
| Pharmacokinetics: Volume of Distribution (V) for Obinutuzumab | 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 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 |
| Pharmacokinetics: Area Under the Concentration-Time Curve 7 Day (AUC7day) | 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 in day times micrograms per milliliter (day*μg/mL). | 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 |
| Pharmacodynamics: Peripheral Blood CD19-positive B-cell Count | Up to approximately 24 months |
| Encinitas |
| California |
| 92024 |
| United States |
| University of Colorado Cancer Center Department of Hematology | Aurora | Colorado | 80045 | United States |
| Rocky Mountain Cancer Ctr - Denver (Williams) | Denver | Colorado | 80218 | United States |
| Norwalk Hospital | Norwalk | Connecticut | 06856 | United States |
| Florida Cancer Specialists; Department of Oncology | Fort Myers | Florida | 33901-8101 | United States |
| Florida Cancer Specialists; Saint Petersburg | St. Petersburg | Florida | 33719 | United States |
| Northwest Georgia Oncology Centers PC - Marietta | Marietta | Georgia | 30060 | United States |
| Kootenai Medical Center | Coeur d'Alene | Idaho | 83814 | United States |
| Northwestern University; Robert H. Lurie Comp Can Ctr | Chicago | Illinois | 60611 | United States |
| Onc Hem Assoc of Central IL | Peoria | Illinois | 61615-7828 | United States |
| McFarland Clinic | Ames | Iowa | 50010 | United States |
| Jewish Cancer Care | Louisville | Kentucky | 40245 | United States |
| University of Massachusetts Medical School | Worcester | Massachusetts | 01655 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109-0934 | United States |
| MT Cancer Inst Fndtn; MT Can Spec | Missoula | Montana | 59802 | United States |
| Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | 89128 | United States |
| MSKCC at Basking Ridge | Basking Ridge | New Jersey | 07920 | United States |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| San Juan Oncology Associates | Farmington | New Mexico | 87401 | United States |
| Memorial Sloan-Kettering; Cancer Center | Commack | New York | 11725 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| MSKCC at Mercy Med Ctr | Rockville Centre | New York | 11570 | United States |
| MSKCC at Sleepy Hollow | Sleepy Hollow | New York | 10591 | United States |
| Emerywood Hematology and Onc | High Point | North Carolina | 27262 | United States |
| Willamette Valley Cancer Insitute and Research Center | Springfield | Oregon | 97477 | United States |
| Medical University of SC (MUSC) | Charleston | South Carolina | 29425 | United States |
| SCRI-Tennessee Oncology | Nashville | Tennessee | 37203 | United States |
| Onc & Hem Assoc; USO Cent Pharm | Fort Worth | Texas | 76177 | United States |
| MD Anderson Cancer Center Department of Lymphoma & Myeloma | Houston | Texas | 77030 | United States |
| Methodist Hospital Research Institute | Houston | Texas | 77030 | United States |
| Cancer Therapy & Research Center | San Antonio | Texas | 78229 | United States |
| USO - Tyler Cancer Ctr | Tyler | Texas | 75702 | United States |
| Blue Ridge Cancer Care - Roanoke | Roanoke | Virginia | 24014 | United States |
| Medical Oncology Associates | Spokane | Washington | 99208 | United States |
| Northwest Cancer Specialists - Vancouver | Vancouver | Washington | 98684 | United States |
| Yakima Valley Memorial Hospital/North Star Lodge | Yakima | Washington | 98902 | United States |
| Aurora Bay Care Medical Center | Green Bay | Wisconsin | 54311 | United States |
| Sharman JP, Forero-Torres A, Costa LJ, Flinn IW, Inhorn L, Kelly K, Bessudo A, Fayad LE, Kaminski MS, Evens AM, Flowers CR, Sahin D, Mundt KE, Sandmann T, Fingerle-Rowson G, Vignal C, Mobasher M, Zelenetz AD. Obinutuzumab plus CHOP is effective and has a tolerable safety profile in previously untreated, advanced diffuse large B-cell lymphoma: the phase II GATHER study. Leuk Lymphoma. 2019 Apr;60(4):894-903. doi: 10.1080/10428194.2018.1515940. Epub 2018 Oct 2. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Obinutuzumab + CHOP | Participants received 1000 mg obinutuzumab intravenously on Day 1 of each 21-day cycle for 8 cycles; during Cycle 1 administration also on Days 8 and 15. Participants also received standard CHOP therapy for 6 cycles. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All participants. | Posted | Number | 95% Confidence Interval | percentage of participants | From the first dose of study treatment to end of treatment response assessment (approximately 228 to 258 days) |
|
|
| |||||||||||||||||||||||||
| Primary | 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. | All participants | Posted | Number | 95% Confidence Interval | percentage of participants | From the first dose of study treatment to end of treatment response assessment (approximately 228 to 258 days) |
|
| ||||||||||||||||||||||||||
| Secondary | 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. | All participants. | Posted | Number | 95% Confidence Interval | percentage of participants | From the first dose of study treatment to end of treatment response assessment (approximately 228 to 258 days) |
|
| ||||||||||||||||||||||||||
| Secondary | 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. | All participants | Posted | Number | 95% Confidence Interval | percentage of participants | From the first dose of study treatment to end of treatment response assessment (approximately 228 to 258 days) |
|
| ||||||||||||||||||||||||||
| Secondary | 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. | All participants. Patients who had not progressed, relapsed or died at the time of analysis were censored on the date of last valid disease assessment. If no tumor assessments were performed after the baseline visit, the patient was censored for PFS at the date after the first dose of study treatments. | Posted | Median | 95% Confidence Interval | months | From the first dose of study treatment to PFS assessment (up to 64 months) |
|
| ||||||||||||||||||||||||||
| Secondary | 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. | All participants with data available. Participants who had not progressed, relapsed, or died at the time of analysis were censored for duration of response at the date of the last valid response assessment. | Posted | Median | Full Range | months | From the response assessment to relapse, progression, or death (up to 64 months) |
|
| ||||||||||||||||||||||||||
| Secondary | 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. | Safety population included all randomized participants who received study drug. | Posted | Number | percentage of participants | From the first dose of study treatment to end of study (up to 5 years 4 months) |
|
| |||||||||||||||||||||||||||
| Secondary | 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. | Participants from the Safety population, all randomized participants who received at least 1 dose of study drug, who received shorter duration infusions. | Posted | Number | participants | From the first dose of study treatment to end of treatment response assessment (approximately 228 to 258 days) |
|
| |||||||||||||||||||||||||||
| Secondary | 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). | PK-Evaluable included all participants with viable PK data for analysis. | Posted | Mean | Standard Deviation | μg/mL | 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 |
|
| ||||||||||||||||||||||||||
| Secondary | Pharmacokinetics: Terminal Half-Life (t1/2) for Obinutuzumab | 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 | PK-Evaluable included all participants with viable PK data for analysis. | Posted | Mean | Standard Deviation | days | 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 |
|
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| Secondary | Pharmacokinetics: Clearance (Cl) for Obinutuzumab | 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). | PK-Evaluable included all participants with viable PK data for analysis. | Posted | Mean | Standard Deviation | mL/day | 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 |
|
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| Secondary | Pharmacokinetics: Volume of Distribution (V) for Obinutuzumab | 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). | PK-Evaluable included all participants with viable PK data for analysis. | Posted | Mean | Standard Deviation | mL | 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 |
|
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| Secondary | Pharmacokinetics: Area Under the Concentration-Time Curve 7 Day (AUC7day) | 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 in day times micrograms per milliliter (day*μg/mL). | PK-Evaluable included all participants with viable PK data for analysis. | Posted | Mean | Standard Deviation | day*μg/mL | 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 |
|
| ||||||||||||||||||||||||||
| Secondary | Pharmacodynamics: Peripheral Blood CD19-positive B-cell Count | Not Posted | Up to approximately 24 months | Participants |
From the first dose of study treatment to clinical data cut-off: 23 December 2016 (up to 5 years, 4 months)
All participants who received at least 1 dose of study drug.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Obinutuzumab + CHOP | Participants received 1000 mg obinutuzumab intravenously on Day 1 of each 21-day cycle for 8 cycles; during Cycle 1 administration also on Days 8 and 15. Participants also received standard CHOP therapy for 6 cycles. | 38 | 100 | 100 | 100 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA, Version 19.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA, Version 19.1 | Systematic Assessment |
| |
| Catheter site cellulitis | Infections and infestations | MedDRA, Version 19.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA, Version 19.1 | Systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | MedDRA, Version 19.1 | Systematic Assessment |
| |
| Pneumonia cytomegaloviral | Infections and infestations | MedDRA, Version 19.1 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA, Version 19.1 | Systematic Assessment |
| |
| Encephalitis | Infections and infestations | MedDRA, Version 19.1 | Systematic Assessment |
| |
| Enterococcal infection | Infections and infestations | MedDRA, Version 19.1 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA, Version 19.1 | Systematic Assessment |
| |
| Herpes zoster disseminated | Infections and infestations | MedDRA, Version 19.1 | Systematic Assessment |
| |
| Colonic abscess | Infections and infestations | MedDRA, Version 19.1 | Systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA, Version 19.1 | Systematic Assessment |
| |
| Pneumonia legionella | Infections and infestations | MedDRA, Version 19.1 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA, Version 19.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA, Version 19.1 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA, Version 19.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA, Version 19.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA, Version 19.1 | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA, Version 19.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA, Version 19.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA, Version 19.1 | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA, Version 19.1 | Systematic Assessment |
| |
| Intestinal perforation | Gastrointestinal disorders | MedDRA, Version 19.1 | Systematic Assessment |
| |
| Intra-abdominal haemorrhage | Gastrointestinal disorders | MedDRA, Version 19.1 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA, Version 19.1 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA, Version 19.1 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA, Version 19.1 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA, Version 19.1 | Systematic Assessment |
| |
| Acute left ventricular failure | Cardiac disorders | MedDRA, Version 19.1 | Systematic Assessment |
| |
| Cardiovascular disorder | Cardiac disorders | MedDRA, Version 19.1 | Systematic Assessment |
| |
| Left ventricular dysfunction | Cardiac disorders | MedDRA, Version 19.1 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 19.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 19.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 19.1 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA, Version 19.1 | Systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | MedDRA, Version 19.1 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA, Version 19.1 | Systematic Assessment |
| |
| Spondylitic myelopathy | Nervous system disorders | MedDRA, Version 19.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA, Version 19.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA, Version 19.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA, Version 19.1 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA, Version 19.1 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA, Version 19.1 | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA, Version 19.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA, Version 19.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA, Version 19.1 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA, Version 19.1 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA, Version 19.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA, Version 19.1 | Systematic Assessment |
| |
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA, Version 19.1 | Systematic Assessment |
| |
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA, Version 19.1 | Systematic Assessment |
| |
| Death | General disorders | MedDRA, Version 19.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | MedDRA, Version 19.1 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA, Version 19.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA, Version 19.1 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA, Version 19.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA, Version 19.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA, Version 19.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA, Version 19.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA, Version 19.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA, Version 19.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA, Version 19.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA, Version 19.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA, Version 19.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA, Version 19.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA, Version 19.1 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA, Version 19.1 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA, Version 19.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA, Version 19.1 | Systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | MedDRA, Version 19.1 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA, Version 19.1 | Systematic Assessment |
| |
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA, Version 19.1 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA, Version 19.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA, Version 19.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA, Version 19.1 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA, Version 19.1 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA, Version 19.1 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA, Version 19.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 19.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 19.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 19.1 | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 19.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA, Version 19.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA, Version 19.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA, Version 19.1 | Systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA, Version 19.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA, Version 19.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA, Version 19.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA, Version 19.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA, Version 19.1 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA, Version 19.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA, Version 19.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA, Version 19.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA, Version 19.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA, Version 19.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA, Version 19.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA, Version 19.1 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA, Version 19.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA, Version 19.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA, Version 19.1 | Systematic Assessment |
| |
| Candida infection | Infections and infestations | MedDRA, Version 19.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA, Version 19.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA, Version 19.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA, Version 19.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA, Version 19.1 | Systematic Assessment |
| |
| Ejection fraction decreased | Investigations | MedDRA, Version 19.1 | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA, Version 19.1 | Systematic Assessment |
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| Tachycardia | Cardiac disorders | MedDRA, Version 19.1 | Systematic Assessment |
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| Lacrimation increased | Eye disorders | MedDRA, Version 19.1 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA, Version 19.1 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA, Version 19.1 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA, Version 19.1 | Systematic Assessment |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Genentech, Inc. | 800-821-8590 | genetech@druginfo.com |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C543332 | obinutuzumab |
| D003520 | Cyclophosphamide |
| D004317 | Doxorubicin |
| D011241 | Prednisone |
| D014750 | Vincristine |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
Not provided
Not provided
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