Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a Phase 2, open-label, multicenter study to evaluate the safety and efficacy of BG induction therapy in participants with previously untreated CLL. The anticipated time on study treatment is 24 weeks.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Obinutuzumab + Bendamustine (BG) | Experimental | Participants received obinutuzumab + bendamustine (BG) induction therapy in 28-day cycles for 6 cycles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bendamustine | Drug | Bendamustine was administered as an intravenous infusion at a dose of 90 milligrams per square meter (mg/m^2) on Days 2 and 3 Cycle 1; and on Days 1 and 2 Cycles 2-6. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Complete Response (CR), as Determined by the Investigator Using International Workshop on Chronic Lymphocytic Leukemia National Cancer Institute-Working Group (iwCLL NCI-WG) Guidelines | The CR rate was defined as CR or CR with incomplete blood count recovery (CRi), assessed by the investigator according to iwCLL NCI-WG criteria. The definition of confirmed CR required all of the following criteria as assessed at least 2 months after completion of therapy: peripheral blood lymphocytes < 4 times 10^9 cells/L; absence of significant lymphadenopathy, hepatomegaly, or splenomegaly due to CLL involvement; absence of constitutional symptoms; normal complete blood count (CBC) without need for transfusion or exogenous growth factors, as exhibited by neutrophils >/= 1.5 times 10^9 cells/L, platelets > 100 times 10^9 cells/L, and hemoglobin > 11.0 g/dL; normocellular BM aspirate with < 30% lymphocytes; absence of lymphoid nodules; and BM biopsy without CLL activity. Those fulfilling CR criteria but who have persistent anemia, thrombocytopenia, or neutropenia were considered CRi. | 2 to 3 months after the last infusion of study treatment (up to approximately 228 to 258 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Objective Response of CR or Partial Response (PR) at the End of Induction Therapy, as Determined by the Investigator Using iwCLL NCI-WG Guidelines | CR is defined in the previous outcome measure. The definition of PR required that the following be documented for minimum 2 months: >/= 50% decrease in peripheral blood lymphocytes from Baseline; reduction in lymphadenopathy; >/= 50% reduction in spleen or liver enlargement; and CBC with one of the following without need for transfusion or exogenous growth factors: polymorphonuclear leukocytes >/= 1.5 times 10^9 cells/L, platelets > 100 times 10^9 cells/L or >/= 50% improvement from Baseline, or hemoglobin > 11.0 g/dL or >/= 50% improvement from Baseline. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clearview Cancer Institute | Huntsville | Alabama | 35805 | United States | ||
| Southern Cancer Center - Mobile |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33243049 | Derived | Sharman JP, Burke JM, Yimer HA, Boxer MA, Babu S, Li J, Mun Y, Danilov AV; GIBB study investigators. Phase 2, multicenter GIBB study of obinutuzumab plus bendamustine in previously untreated patients with chronic lymphocytic leukemia. Leuk Lymphoma. 2021 Apr;62(4):791-800. doi: 10.1080/10428194.2020.1850719. Epub 2020 Nov 26. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Obinutuzumab + Bendamustine (BG) | Participants received obinutuzumab + bendamustine (BG) therapy in 28-day cycles for 6 cycles. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Obinutuzumab | Drug | Obinutuzumab was administered as an intravenous infusion at a dose of 100 milligrams (mg) on Day 1 Cycle 1; at a dose of 900 mg on Day 2 Cycle 1; at a dose of 1000 mg on Days 8 and 15 Cycle 1, and Day 1 Cycles 2-6. |
|
|
| 2 to 3 months after the last infusion of study treatment (up to approximately 228 to 258 days) |
| Duration of Response Among Participants With Objective Response of CR or PR, as Determined by the Investigator Using iwCLL NCI-WG Guidelines | Duration of response was defined as the time from the first assessment of CR, CRi, PR, or nodular partial response (nPR) to the first documentation of PD or death, whichever occurred first. CR, CRi, and PR are identified in previous outcome measures. Participants with lymphoid nodules who otherwise met CR criteria were considered nPR. Participants with post-baseline response assessments (excluding progressive disease) but with no end-of-induction treatment response available were censored on Day 1, and those with end-of-induction treatment response available but who did not experience death or disease progression before the end of the study were censored on the day of the last available assessment. | From the first assessment of CR, CRi, PR, or nPR (at up to approximately 228 to 258 days) until disease progression, relapse, or death from any cause, whichever occurred first (up to 46 months) |
| Progression-Free Survival (PFS), as Determined by the Investigator Using iwCLL NCI-WG Guidelines | PFS was defined as the time from the start of induction treatment (Day 1) to the first occurrence of disease progression, relapse as determined by the investigator using iwCLL NCI WG guidelines, or death (within 28 days after the last dose of study drug), whichever occurred first. Disease progression: at least one of the following: lymphadenopathy; increase in the liver or spleen size by 50% or more or the appearance of hepatomegaly or splenomegaly; an increase in the number of blood lymphocytes by 50% or more with at least 5000 B lymphocytes per microliter; transformation to a more aggressive histology; occurrence of cytopenia (neutropenia, anemia, or thrombocytopenia) attributable to CLL. Relapse: Having achieved CR or PR, but after a period of 6 or more months, having demonstrated evidence of disease progression. Participants who did not experience death or disease progression before the end of the study were censored on the day of the last available assessment. | Day 1 until disease progression, relapse, or death from any cause, whichever occurred first (up to 46 months) |
| Overall Survival (OS) | OS was defined as the time from the start of induction treatment to death from any cause. Participants who did not experience death or disease progression before the end of the study were censored on the day of the last available assessment. | Day 1 until death from any cause (up to 46 months) |
| Percentage of Participants Who Achieved Minimal Residual Disease (MRD)-Negative Status in Bone Marrow at Any Time During the Study | MRD was assessed by 4-color flow cytometry, using iwCLL criteria for MRD negativity (<1 CLL cell detected in 10,000 leukocytes) in bone marrow aspirate. Flow cytometry provides rapid analysis of multiple characteristics of single cells by using light to count and profile cells in a fluid mixture. | Up to 46 months |
| Percentage of Participants Who Achieved MRD-Negative Status in Peripheral Blood at Any Time During the Study | MRD was assessed by 4-color flow cytometry, using iwCLL criteria for MRD negativity (<1 CLL cell detected in 10,000 leukocytes) in peripheral blood. Flow cytometry provides rapid analysis of multiple characteristics of single cells by using light to count and profile cells in a fluid mixture. | Baseline up to 46 months |
| Time to MRD-Negative Status in Peripheral Blood | MRD was assessed by 4-color flow cytometry, using iwCLL criteria for MRD negativity if the value is <10^-4 (<1 CLL cell detected in 10,000 leukocytes) in peripheral blood. Flow cytometry provides rapid analysis of multiple characteristics of single cells by using light to count and profile cells in a fluid mixture. Time to MRD-negative status is defined as the time between MRD positivity (>= 10^-4) or the time of first dose treatment for patients who were missing MRD status assessment at baseline to the first achievement of MRD negativity in the peripheral blood. | Baseline up to 46 months |
| Duration of MRD-Negativity in Peripheral Blood Among Participants Who Achieved MRD-Negative Status | MRD was assessed by 4-color flow cytometry, using iwCLL criteria for MRD negativity (<1 CLL cell detected in 10,000 leukocytes) in peripheral blood. Flow cytometry provides rapid analysis of multiple characteristics of single cells by using light to count and profile cells in a fluid mixture. Duration of MRD-negativity among patients who achieved MRD negativity in the study is defined as the period between the first occurrence of MRD-negative status and a subsequent MRD-positive status. | Baseline up to 46 months |
| Minimum Observed Concentration (Ctrough) of Obinutuzumab After Cycle 2 | Ctrough is the measured concentration of a drug at the end of a dosing interval at steady state. | Pre-infusion (0 hours) on Day 1 Cycle 3 (1 cycle = 28 days) |
| Ctrough of Obinutuzumab After Cycle 4 | Ctrough is the measured concentration of a drug at the end of a dosing interval at steady state. | Pre-infusion (0 hours) on Day 1 Cycle 5 (1 cycle = 28 days) |
| Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | The EORTC QLQ-C30 included global health status, functional scales (physical, role, emotional, cognitive, and social), symptom scales (fatigue, nausea/vomiting, and pain) and single items (dyspnoea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Most questions used a 4-point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale [1 'very poor' to 7 'Excellent']). Scores were averaged and transformed to 0 - 100 scale, whereby higher scores indicate greater functioning, greater quality of life, or a greater degree of symptoms, with changes of 5 - 10 points considered to be a minimally important difference to participants. A positive change from Day 1, Cycle 1 (baseline) indicates improvement. EOT=end of treatment. | Day 1 Cycles 1 (baseline), 3, 6; end of treatment, 2 months after last dose, every 3 months thereafter for 2 years (up to 46 months) (1 cycle = 28 days) |
| Change From Baseline in the EORTC Quality of Life Questionnaire-Chronic Lymphocytic Leukemia 16 (QLQ-CLL16) Score | The EORTC Quality of Life Questionnaire-Chronic Lymphocytic Leukemia 16 (QLQ-CLL16) module included assessments of fatigue, treatment side effects, disease symptoms, infection, social activities, and future health worries. Final scores are transformed such that they range from 0 - 100, whereby higher scores indicate greater functioning, greater quality of life, or a greater degree of symptoms, with changes of 5 - 10 points considered to be a minimally important difference to participants. A positive change from Day 1, Cycle 1 (baseline) indicates improvement. EOT=end of treatment. | Day 1 Cycles 1 (baseline), 3, 6; end of treatment, 2 months after last dose, every 3 months thereafter for 2 years (up to 46 months) (1 cycle = 28 days) |
| Number of Hospitalizations Due to Adverse Events (AEs) | An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not considered related to the study drug. | Day 1 up to 46 months |
| Percentage of Participants With Adverse Events (AEs) | An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not considered related to the study drug. | Day 1 up to 46 months |
| Mobile |
| Alabama |
| 36608 |
| United States |
| Ironwood Cancer TX & Rsch Ctrs | Chandler | Arizona | 85224 | United States |
| Arizona Oncology Associates, PC - HAL | Tempe | Arizona | 85284 | United States |
| Arizona Oncology Associates, PC - HOPE | Tucson | Arizona | 85704 | United States |
| Highlands Oncology Group | Fayetteville | Arkansas | 72703 | United States |
| Rocky Mountain Cancer Center - Aurora | Aurora | Colorado | 80012 | United States |
| Cancer Care and Hematology | Fort Collins | Colorado | 80528 | United States |
| Piedmont Cancer Institute, PC | Atlanta | Georgia | 30318 | United States |
| Northwest Georgia Oncology Centers PC - Marietta | Marietta | Georgia | 30060 | United States |
| Cancer Care & Hematology; Specialists of Chicagoland | Niles | Illinois | 60714 | United States |
| Fort Wayne Med Oncology & Hematology Inc | Fort Wayne | Indiana | 46845 | United States |
| Center For Cancer and Blood Disorders | Bethesda | Maryland | 20817 | United States |
| Regional Cancer Care Associates LLC - Morristown | Morristown | New Jersey | 07962 | United States |
| San Juan Oncology Associates | Farmington | New Mexico | 87401 | United States |
| Stony Brook University Hospital | Stony Brook | New York | 11794 | United States |
| Northwest Cancer Specialists - Portland (N Broadway) | Portland | Oregon | 97227 | United States |
| Oregon Health and Science University | Portland | Oregon | 97239 | United States |
| Willamette Valley Cancer Insitute and Research Center | Springfield | Oregon | 97477 | United States |
| Texas Oncology-Arlington | Arlington | Texas | 76012 | United States |
| Texas Oncology-Tyler | Irving | Texas | 75063 | United States |
| Joe Arrington Cancer Research & Treatment Center | Lubbock | Texas | 79410 | United States |
| Cancer Care Centers of South Texas-HOAST - San Antonio | New Braunfels | Texas | 78130 | United States |
| Northern Utah Associates | Ogden | Utah | 84403 | United States |
| Virginia Cancer Specialists, PC | Fairfax | Virginia | 22031 | United States |
| Yakima Valley Memorial Hospital/North Star Lodge | Yakima | Washington | 98902 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Obinutuzumab + Bendamustine (BG) | Participants received obinutuzumab + bendamustine (BG) therapy in 28-day cycles 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 |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | 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 | Percentage of Participants With Complete Response (CR), as Determined by the Investigator Using International Workshop on Chronic Lymphocytic Leukemia National Cancer Institute-Working Group (iwCLL NCI-WG) Guidelines | The CR rate was defined as CR or CR with incomplete blood count recovery (CRi), assessed by the investigator according to iwCLL NCI-WG criteria. The definition of confirmed CR required all of the following criteria as assessed at least 2 months after completion of therapy: peripheral blood lymphocytes < 4 times 10^9 cells/L; absence of significant lymphadenopathy, hepatomegaly, or splenomegaly due to CLL involvement; absence of constitutional symptoms; normal complete blood count (CBC) without need for transfusion or exogenous growth factors, as exhibited by neutrophils >/= 1.5 times 10^9 cells/L, platelets > 100 times 10^9 cells/L, and hemoglobin > 11.0 g/dL; normocellular BM aspirate with < 30% lymphocytes; absence of lymphoid nodules; and BM biopsy without CLL activity. Those fulfilling CR criteria but who have persistent anemia, thrombocytopenia, or neutropenia were considered CRi. | The modified intent-to-treat (mITT) population included enrolled participants who received at least one dose of BG. | Posted | Number | 95% Confidence Interval | percentage of participants | 2 to 3 months after the last infusion of study treatment (up to approximately 228 to 258 days) |
|
|
| |||||||||||||||||||||||||
| Secondary | Percentage of Participants With Objective Response of CR or Partial Response (PR) at the End of Induction Therapy, as Determined by the Investigator Using iwCLL NCI-WG Guidelines | CR is defined in the previous outcome measure. The definition of PR required that the following be documented for minimum 2 months: >/= 50% decrease in peripheral blood lymphocytes from Baseline; reduction in lymphadenopathy; >/= 50% reduction in spleen or liver enlargement; and CBC with one of the following without need for transfusion or exogenous growth factors: polymorphonuclear leukocytes >/= 1.5 times 10^9 cells/L, platelets > 100 times 10^9 cells/L or >/= 50% improvement from Baseline, or hemoglobin > 11.0 g/dL or >/= 50% improvement from Baseline. | The mITT population included enrolled participants who received at least one dose of BG. | Posted | Number | 95% Confidence Interval | percentage of participants | 2 to 3 months after the last infusion of study treatment (up to approximately 228 to 258 days) |
|
| ||||||||||||||||||||||||||
| Secondary | Duration of Response Among Participants With Objective Response of CR or PR, as Determined by the Investigator Using iwCLL NCI-WG Guidelines | Duration of response was defined as the time from the first assessment of CR, CRi, PR, or nodular partial response (nPR) to the first documentation of PD or death, whichever occurred first. CR, CRi, and PR are identified in previous outcome measures. Participants with lymphoid nodules who otherwise met CR criteria were considered nPR. Participants with post-baseline response assessments (excluding progressive disease) but with no end-of-induction treatment response available were censored on Day 1, and those with end-of-induction treatment response available but who did not experience death or disease progression before the end of the study were censored on the day of the last available assessment. | The mITT population included enrolled participants who received at least one dose of BG. Analysis performed for participants with response. | Posted | Median | 95% Confidence Interval | months | From the first assessment of CR, CRi, PR, or nPR (at up to approximately 228 to 258 days) until disease progression, relapse, or death from any cause, whichever occurred first (up to 46 months) |
|
| ||||||||||||||||||||||||||
| Secondary | Progression-Free Survival (PFS), as Determined by the Investigator Using iwCLL NCI-WG Guidelines | PFS was defined as the time from the start of induction treatment (Day 1) to the first occurrence of disease progression, relapse as determined by the investigator using iwCLL NCI WG guidelines, or death (within 28 days after the last dose of study drug), whichever occurred first. Disease progression: at least one of the following: lymphadenopathy; increase in the liver or spleen size by 50% or more or the appearance of hepatomegaly or splenomegaly; an increase in the number of blood lymphocytes by 50% or more with at least 5000 B lymphocytes per microliter; transformation to a more aggressive histology; occurrence of cytopenia (neutropenia, anemia, or thrombocytopenia) attributable to CLL. Relapse: Having achieved CR or PR, but after a period of 6 or more months, having demonstrated evidence of disease progression. Participants who did not experience death or disease progression before the end of the study were censored on the day of the last available assessment. | The mITT population included enrolled participants who received at least one dose of BG. | Posted | Median | 95% Confidence Interval | months | Day 1 until disease progression, relapse, or death from any cause, whichever occurred first (up to 46 months) |
| |||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | OS was defined as the time from the start of induction treatment to death from any cause. Participants who did not experience death or disease progression before the end of the study were censored on the day of the last available assessment. | The mITT population included enrolled participants who received at least one dose of BG. | Posted | Median | 95% Confidence Interval | months | Day 1 until death from any cause (up to 46 months) |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Achieved Minimal Residual Disease (MRD)-Negative Status in Bone Marrow at Any Time During the Study | MRD was assessed by 4-color flow cytometry, using iwCLL criteria for MRD negativity (<1 CLL cell detected in 10,000 leukocytes) in bone marrow aspirate. Flow cytometry provides rapid analysis of multiple characteristics of single cells by using light to count and profile cells in a fluid mixture. | The mITT population included enrolled participants who received at least one dose of BG. Data are reported for evaluable participants. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 46 months |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Achieved MRD-Negative Status in Peripheral Blood at Any Time During the Study | MRD was assessed by 4-color flow cytometry, using iwCLL criteria for MRD negativity (<1 CLL cell detected in 10,000 leukocytes) in peripheral blood. Flow cytometry provides rapid analysis of multiple characteristics of single cells by using light to count and profile cells in a fluid mixture. | The mITT population included enrolled participants who received at least one dose of BG. Data are reported for evaluable participants. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline up to 46 months |
|
| ||||||||||||||||||||||||||
| Secondary | Time to MRD-Negative Status in Peripheral Blood | MRD was assessed by 4-color flow cytometry, using iwCLL criteria for MRD negativity if the value is <10^-4 (<1 CLL cell detected in 10,000 leukocytes) in peripheral blood. Flow cytometry provides rapid analysis of multiple characteristics of single cells by using light to count and profile cells in a fluid mixture. Time to MRD-negative status is defined as the time between MRD positivity (>= 10^-4) or the time of first dose treatment for patients who were missing MRD status assessment at baseline to the first achievement of MRD negativity in the peripheral blood. | The mITT population included enrolled participants who received at least one dose of BG. | Posted | Median | 95% Confidence Interval | months | Baseline up to 46 months |
|
| ||||||||||||||||||||||||||
| Secondary | Duration of MRD-Negativity in Peripheral Blood Among Participants Who Achieved MRD-Negative Status | MRD was assessed by 4-color flow cytometry, using iwCLL criteria for MRD negativity (<1 CLL cell detected in 10,000 leukocytes) in peripheral blood. Flow cytometry provides rapid analysis of multiple characteristics of single cells by using light to count and profile cells in a fluid mixture. Duration of MRD-negativity among patients who achieved MRD negativity in the study is defined as the period between the first occurrence of MRD-negative status and a subsequent MRD-positive status. | The mITT population included enrolled participants who received at least one dose of BG. Data are reported for evaluable participants. | Posted | Median | 95% Confidence Interval | months | Baseline up to 46 months |
|
| ||||||||||||||||||||||||||
| Secondary | Minimum Observed Concentration (Ctrough) of Obinutuzumab After Cycle 2 | Ctrough is the measured concentration of a drug at the end of a dosing interval at steady state. | The PK (pharmacokinetic) Evaluable Population included all ITT participants in the study who received any dose of study drug (obinutuzumab or bendamustine) and had at least one PK assessment. Data are reported for evaluable participants. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms per milliliter (ng/mL) | Pre-infusion (0 hours) on Day 1 Cycle 3 (1 cycle = 28 days) |
|
| ||||||||||||||||||||||||||
| Secondary | Ctrough of Obinutuzumab After Cycle 4 | Ctrough is the measured concentration of a drug at the end of a dosing interval at steady state. | The PK (pharmacokinetic) Evaluable Population included all ITT participants in the study who received any dose of study drug (obinutuzumab or bendamustine) and had at least one PK assessment. Data are reported for evaluable participants. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms per milliliter (ng/mL) | Pre-infusion (0 hours) on Day 1 Cycle 5 (1 cycle = 28 days) |
|
| ||||||||||||||||||||||||||
| Secondary | Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | The EORTC QLQ-C30 included global health status, functional scales (physical, role, emotional, cognitive, and social), symptom scales (fatigue, nausea/vomiting, and pain) and single items (dyspnoea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Most questions used a 4-point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale [1 'very poor' to 7 'Excellent']). Scores were averaged and transformed to 0 - 100 scale, whereby higher scores indicate greater functioning, greater quality of life, or a greater degree of symptoms, with changes of 5 - 10 points considered to be a minimally important difference to participants. A positive change from Day 1, Cycle 1 (baseline) indicates improvement. EOT=end of treatment. | The PRO (patient-reported outcome) Evaluable Population included all ITT participants in the study who received any dose of study treatment (obinutuzumab or bendamustine) and had both a non-missing baseline and at least one post-baseline PRO assessment. Data were not collected for the second year of follow up. | Posted | Mean | Standard Deviation | score on a scale | Day 1 Cycles 1 (baseline), 3, 6; end of treatment, 2 months after last dose, every 3 months thereafter for 2 years (up to 46 months) (1 cycle = 28 days) |
| |||||||||||||||||||||||||||
| Secondary | Change From Baseline in the EORTC Quality of Life Questionnaire-Chronic Lymphocytic Leukemia 16 (QLQ-CLL16) Score | The EORTC Quality of Life Questionnaire-Chronic Lymphocytic Leukemia 16 (QLQ-CLL16) module included assessments of fatigue, treatment side effects, disease symptoms, infection, social activities, and future health worries. Final scores are transformed such that they range from 0 - 100, whereby higher scores indicate greater functioning, greater quality of life, or a greater degree of symptoms, with changes of 5 - 10 points considered to be a minimally important difference to participants. A positive change from Day 1, Cycle 1 (baseline) indicates improvement. EOT=end of treatment. | The PRO Evaluable Population included all ITT participants in the study who received any dose of study treatment (obinutuzumab or bendamustine) and had both a non-missing baseline and at least one post-baseline PRO assessment. Data were not collected for the second year of follow up. | Posted | Mean | Standard Deviation | score on a scale | Day 1 Cycles 1 (baseline), 3, 6; end of treatment, 2 months after last dose, every 3 months thereafter for 2 years (up to 46 months) (1 cycle = 28 days) |
|
| ||||||||||||||||||||||||||
| Secondary | Number of Hospitalizations Due to Adverse Events (AEs) | An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not considered related to the study drug. | The safety population included participants who received any amount of study treatment. | Posted | Mean | Standard Deviation | hospitalizations | Day 1 up to 46 months |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Adverse Events (AEs) | An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not considered related to the study drug. | The safety population included participants who received any amount of study treatment. | Posted | Number | percentage of participants | Day 1 up to 46 months |
|
|
Day 1 up to 46 months
Not provided
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 + Bendamustine (BG) | Participants received obinutuzumab + bendamustine (BG) therapy in 28-day cycles for 6 cycles. | 7 | 102 | 31 | 102 | 101 | 102 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA, Version 21.1 | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA, Version 21.1 | Non-systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA, Version 21.1 | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA, Version 21.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA, Version 21.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA, Version 21.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA, Version 21.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA, Version 21.1 | Non-systematic Assessment |
| |
| Catheter site infection | Infections and infestations | MedDRA, Version 21.1 | Non-systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA, Version 21.1 | Non-systematic Assessment |
| |
| Oesophageal candidiasis | Infections and infestations | MedDRA, Version 21.1 | Non-systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA, Version 21.1 | Non-systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA, Version 21.1 | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA, Version 21.1 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA, Version 21.1 | Non-systematic Assessment |
| |
| Tumour lysis syndrome | Metabolism and nutrition disorders | MedDRA, Version 21.1 | Non-systematic Assessment |
| |
| Failure to thrive | Metabolism and nutrition disorders | MedDRA, Version 21.1 | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 21.1 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA, Version 21.1 | Non-systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA, Version 21.1 | Non-systematic Assessment |
| |
| Progressive multifocal leukoencephalopathy | Infections and infestations | MedDRA, Version 21.1 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA, Version 21.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA, Version 21.1 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA, Version 21.1 | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA, Version 21.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA, Version 21.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA, Version 21.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA, Version 21.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA, Version 21.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA, Version 21.1 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA, Version 21.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA, Version 21.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA, Version 21.1 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA, Version 21.1 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA, Version 21.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA, Version 21.1 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA, Version 21.1 | Non-systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA, Version 21.1 | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA, Version 21.1 | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA, Version 21.1 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA, Version 21.1 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA, Version 21.1 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA, Version 21.1 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA, Version 21.1 | Non-systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA, Version 21.1 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA, Version 21.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA, Version 21.1 | Non-systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA, Version 21.1 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA, Version 21.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA, Version 21.1 | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA, Version 21.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA, Version 21.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA, Version 21.1 | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA, Version 21.1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA, Version 21.1 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA, Version 21.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 21.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 21.1 | Non-systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 21.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA, Version 21.1 | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA, Version 21.1 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA, Version 21.1 | Non-systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA, Version 21.1 | Non-systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA, Version 21.1 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA, Version 21.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA, Version 21.1 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA, Version 21.1 | Non-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 | Hoffmann-LaRoche | 800-821-8590 | genentech@druginfo.com |
| ID | Term |
|---|---|
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| ID | Term |
|---|---|
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069461 | Bendamustine Hydrochloride |
| C543332 | obinutuzumab |
| ID | Term |
|---|---|
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
| Participants |
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|