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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-000576-26 | EudraCT Number |
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| Name | Class |
|---|---|
| AbbVie | INDUSTRY |
This open-label, international, multicenter study will investigate the safety and efficacy of venetoclax (GDC-0199) in combination with bendamustine plus rituximab (venetoclax + BR) compared with BR alone in participants with relapsed and refractory fNHL, comparing two chemotherapy-containing regimens (Chemotherapy-Containing Cohort). In addition, an exploratory analysis of the safety and efficacy of venetoclax in combination with rituximab (venetoclax + rituximab), a chemotherapy-free regimen, will be performed (Chemotherapy-Free Cohort). Assignment to the Chemotherapy-Containing or Chemotherapy-Free Cohort will be decided at the discretion of the Investigator, unless one of the cohorts is not open to enrollment; in which case, participants may be enrolled only to the open cohort. The first 6 participants enrolled in the Chemotherapy-Containing Cohort (or more if required) will comprise the Safety Run-In group for Treatment Arm B, dosing venetoclax at 600 milligrams (mg) in combination with BR. Once a dose has been chosen from the Safety Run-In Period, randomization to the two treatment arms of the Chemotherapy-Containing Cohort (Arms B and C) will begin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR) | Experimental | Participants will receive venetoclax no more than 600 milligrams (mg) orally once daily continuously along with rituximab 375 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of the 28-day cycle. Safety run-in will continue until first 9 participants complete the safety observation window of 28 days. Participants will continue receiving the same treatment as decided for Arm B. |
|
| Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab) | Experimental | Participants will receive venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle will be of 28 days. |
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| Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR) | Experimental | Participants will receive venetoclax at doses decided from safety run-in orally once daily continuously for 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles. |
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| Chemotherapy-Containing Cohort: Arm C (BR) | Active Comparator | Participants will receive rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Venetoclax | Drug | Venetoclax will be administered as per the schedule specified under arm description. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Complete Metabolic Response (CMR) According to Independent Review Committee (IRC) as Per Lugano Classification, Using Positron Emission Tomography (PET) Scan at Primary Response Assessment (PRA) | CMR: a score 1 (no uptake above background), 2 (uptake less than or equal to [<=] mediastinum), or 3 (uptake less than [<] mediastinum but <=liver) with or without a residual mass on PET 5-point scale (5-PS), for lymph nodes and extralymphatic sites with no new lesions and no evidence of fluorodeoxyglucose (FDG)-avid disease in bone marrow. Assessment was performed by an IRC according to Lugano classification using PET scan. 95% confidence interval (CI) for percentage of responders was calculated using Clopper-Pearson method. | 6-8 weeks after Cycle 6 Day 1 (PRA) (Cycle length = 28 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With CMR According to Investigator as Per Lugano Classification, Using PET Scan at PRA | CMR: a score 1 (no uptake above background), 2 (uptake <=mediastinum), or 3 (\ |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southern Cancer Center, PC | Mobile | Alabama | 36608 | United States | ||
| Arizona Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32785666 | Derived | Zinzani PL, Flinn IW, Yuen SLS, Topp MS, Rusconi C, Fleury I, Le Du K, Arthur C, Pro B, Gritti G, Crump M, Petrich A, Samineni D, Sinha A, Punnoose EA, Szafer-Glusman E, Spielewoy N, Mobasher M, Humphrey K, Kornacker M, Hiddemann W. Venetoclax-rituximab with or without bendamustine vs bendamustine-rituximab in relapsed/refractory follicular lymphoma. Blood. 2020 Dec 3;136(23):2628-2637. doi: 10.1182/blood.2020005588. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR) | Participants received venetoclax no more than 600 milligrams (mg) orally once daily continuously along with rituximab 375 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of the 28-day cycle. Safety run-in continued until first 9 participants completed the safety observation window of 28 days. After first 28 days of safety observation (Cycle 1), participants continued to receive venetoclax 600 mg orally once daily up to 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Bendamustine | Drug | Bendamustine will be administered as per the schedule specified under arm description. |
|
|
| Rituximab | Drug | Rituximab will be administered as per the schedule specified under arm description. |
|
|
| 4-10 weeks after Cycle 6 Day 1 (Cycle length = 28 days) |
| Percentage of Participants With CMR According to IRC as Per Lugano Classification, Using PET Scan at Year 1 | CMR: a score 1 (no uptake above background), 2 (uptake <=mediastinum), or 3 (uptake \ | 48-56 weeks after Cycle 1 Day 1 (Cycle length = 28 days) |
| Percentage of Participants With CMR According to Investigator as Per Lugano Classification, Using PET Scan at Year 1 | CMR: a score 1 (no uptake above background), 2 (uptake <=mediastinum), or 3 (\ | 48-56 weeks after Cycle 1 Day 1 (Cycle length = 28 days) |
| Percentage of Participants With Complete Response (CR) According to IRC as Per Lugano Classification, Using Computed Tomography (CT) Scan | CR: defined as reduction of longest transverse diameter of lesion (LDi) of target nodes/nodal masses to <=1.5 centimeters (cm), and no extralymphatic sites of disease; absence of non-measured lesions and new lesions; reduction of enlarged organs to normal; and normal/immunohistochemistry (IHC)-negative bone marrow morphology. Assessment was performed by an IRC according to Lugano classification using CT scan. 95% CI for percentage of responders was calculated using Clopper-Pearson method. | 6-8 weeks after Cycle 6 Day 1 and 48-56 weeks after Cycle 1 Day 1 (Cycle length = 28 days) |
| Percentage of Participants With CR According to Investigator as Per Lugano Classification, Using CT Scan | CR: defined as reduction of LDi of target nodes/nodal masses to <=1.5 cm, and no extralymphatic sites of disease; absence of non-measured lesions and new lesions; reduction of enlarged organs to normal; and normal/IHC-negative bone marrow morphology. Assessment was performed by Investigator according to Lugano classification using CT scan. 95% CI for percentage of responders was calculated using Clopper-Pearson method. | 4-10 weeks after Cycle 6 Day 1 and 48-56 weeks after Cycle 1 Day 1 (Cycle length = 28 days) |
| Percentage of Participants With Objective Response (OR) According to IRC as Per Lugano Classification, Using PET Scan | OR was defined as CMR or Partial Metabolic Response (PMR). CMR: a score 1 (no uptake above background), 2 (uptake <=mediastinum), or 3 (<mediastinum but <=liver) with or without a residual mass on PET 5-PS, for lymph nodes and extralymphatic sites with no new lesions and no evidence of FDG-avid disease in bone marrow. PMR: a score 4 (uptake moderately greater than [>] liver) or 5 (uptake markedly >liver and/or new lesions) with reduced uptake compared with baseline and residual mass(es) of any size on PET 5-PS for lymph nodes and extralymphatic sites with no new lesions and reduced residual uptake in bone marrow compared with baseline. Assessment was performed by an IRC according to Lugano classification using PET scan. 95% CI for percentage of responders was calculated using Clopper-Pearson method. | 6-8 weeks after Cycle 6 Day 1 and 48-56 weeks after Cycle 1 Day 1 (Cycle length = 28 days) |
| Percentage of Participants With OR According to Investigator as Per Lugano Classification, Using PET Scan | OR was defined as CMR or PMR. CMR: a score 1 (no uptake above background), 2 (uptake <=mediastinum), or 3 (<mediastinum but <=liver) with or without a residual mass on PET 5-PS, for lymph nodes and extralymphatic sites with no new lesions and no evidence of FDG-avid disease in bone marrow. PMR: a score 4 (uptake moderately >liver) or 5 (uptake markedly >liver and/or new lesions) with reduced uptake compared with baseline and residual mass(es) of any size on PET 5-PS for lymph nodes and extralymphatic sites with no new lesions and reduced residual uptake in bone marrow compared with baseline. Assessment was performed by Investigator according to Lugano classification using PET scan. 95% CI for percentage of responders was calculated using Clopper-Pearson method. | 4-10 weeks after Cycle 6 Day 1 and 48-56 weeks after Cycle 1 Day 1 (Cycle length = 28 days) |
| Percentage of Participants With OR According to IRC as Per Lugano Classification, Using CT Scan | OR was defined as CR or Partial Response (PR). CR: reduction of LDi of target nodes/nodal masses to <=1.5 cm, and no extralymphatic sites of disease; absence of non-measured lesions and new lesions; reduction of enlarged organs to normal; and normal/IHC-negative bone marrow morphology. PR: greater than or equal to (>=) 50 percent (%) decrease in sum of the product of the perpendicular diameters (SPD) of up to 6 target measurable nodes and extra-nodal sites; absence/reduction/no increase in size of non-measured lesions; reduction in length of spleen at least >50% beyond normal; and no new lesions. Assessment was performed by an IRC according to Lugano classification using CT scan. 95% CI for percentage of responders was calculated using Clopper-Pearson method. | 6-8 weeks after Cycle 6 Day 1 and 48-56 weeks after Cycle 1 Day 1 (Cycle length = 28 days) |
| Percentage of Participants With OR According to Investigator as Per Lugano Classification, Using CT Scan | OR was defined as CR or PR. CR: reduction of LDi of target nodes/nodal masses to <=1.5 cm, and no extralymphatic sites of disease; absence of non-measured lesions and new lesions; reduction of enlarged organs to normal; and normal/IHC-negative bone marrow morphology. PR: >=50% decrease in SPD of up to 6 target measurable nodes and extra-nodal sites; absence/reduction/no increase in size of non-measured lesions; reduction in length of spleen at least >50% beyond normal; and no new lesions. Assessment was performed by Investigator according to Lugano classification using CT scan. 95% CI for percentage of responders was calculated using Clopper-Pearson method. | 4-10 weeks after Cycle 6 Day 1 and 48-56 weeks after Cycle 1 Day 1 (Cycle length = 28 days) |
| Percentage of Participants With OR According to Investigator as Per Lugano Classification, Using PET or CT Scan | OR was defined as CMR/CR or PMR/PR. CMR, CR, PMR, and PR have been defined in previous endpoints, and are not repeated here due to space constraint. Assessment was performed by Investigator according to Lugano classification using PET scan or CT scan (if PET is missing). | Baseline until disease progression or death due to any cause (assessed up to approximately 2.5 years) |
| Duration of Response (DOR) According to Investigator as Per Lugano Classification, Using PET or CT Scan | DOR was defined as time from CMR/CR or PMR/PR until progressive disease (PD) or death due to any cause. CMR, CR, PMR, and PR have been defined in previous endpoints, and are not repeated here due to space constraint. PD: a score 4 (uptake moderately >liver) or 5 (uptake markedly >liver and/or new lesions) with increase in intensity of uptake from baseline on PET 5-PS for individual target nodes/nodal lesions; new FDG-avid foci for extranodal lesions; new FDG-avid foci consistent with lymphoma for new lesions; or new or recurrent FDG-avid foci for bone marrow. Assessment was performed by Investigator according to Lugano classification using PET scan or CT scan (if PET is missing). DOR was calculated using Kaplan-Meier method. | From CMR or PMR until disease progression or death due to any cause (assessed up to approximately 2.5 years) |
| Percentage of Participants With Disease Progression (According to Investigator as Per Lugano Classification, Using PET or CT Scan) or Death | PD: a score 4 (uptake moderately >liver) or 5 (uptake markedly >liver and/or new lesions) with increase in intensity of uptake from baseline on PET 5-PS for individual target nodes/nodal lesions; new FDG-avid foci for extranodal lesions; new FDG-avid foci consistent with lymphoma for new lesions; or new or recurrent FDG-avid foci for bone marrow. Assessment was performed by Investigator according to Lugano classification using PET or CT scan. | Baseline until disease progression or death due to any cause (assessed up to approximately 2.5 years) |
| Progression-Free Survival (PFS) According to Investigator as Per Lugano Classification, Using PET or CT Scan | PFS was defined as the period from the date of treatment initiation (Safety Run-in and Arm A) or randomization date (Arms B and C) until the date of disease progression, or death due to any cause. PD: a score 4 (uptake moderately >liver) or 5 (uptake markedly >liver and/or new lesions) with increase in intensity of uptake from baseline on PET 5-PS for individual target nodes/nodal lesions; new FDG-avid foci for extranodal lesions; new FDG-avid foci consistent with lymphoma for new lesions; or new or recurrent FDG-avid foci for bone marrow. Assessment was performed by Investigator according to Lugano classification using PET or CT scan. PFS was calculated using Kaplan-Meier method. | Baseline until disease progression or death due to any cause (assessed up to approximately 2.5 years) |
| Percentage of Participants With Disease Progression (According to Investigator as Per Lugano Classification, Using PET or CT Scan), Death, or Start of a New Anti-lymphoma Therapy | PD: a score 4 (uptake moderately >liver) or 5 (uptake markedly >liver and/or new lesions) with increase in intensity of uptake from baseline on PET 5-PS for individual target nodes/nodal lesions; new FDG-avid foci for extranodal lesions; new FDG-avid foci consistent with lymphoma for new lesions; or new or recurrent FDG-avid foci for bone marrow. Assessment was performed by Investigator according to Lugano classification using PET or CT scan. | Baseline until disease progression, death, or start of a new anti-lymphoma therapy whichever occurred first (assessed up to approximately 2.5 years) |
| Event-Free Survival (EFS) According to Investigator as Per Lugano Classification, Using PET or CT Scan | EFS was defined as the period from the date of treatment initiation (Safety Run-in and Arm A) or randomization date (Arms B and C) to the date of disease progression, death, or start of a new anti-lymphoma therapy whichever occurred first. PD: a score 4 (uptake moderately >liver) or 5 (uptake markedly >liver and/or new lesions) with increase in intensity of uptake from baseline on PET 5-PS for individual target nodes/nodal lesions; new FDG-avid foci for extranodal lesions; new FDG-avid foci consistent with lymphoma for new lesions; or new or recurrent FDG-avid foci for bone marrow. Assessment was performed by Investigator according to Lugano classification using PET or CT scan. EFS was calculated using Kaplan-Meier method. | Baseline until disease progression, death, or start of a new anti-lymphoma therapy whichever occurred first (assessed up to approximately 2.5 years) |
| Percentage of Participants Who Died Due to Any Cause | Baseline until death due to any cause (assessed up to approximately 2.5 years |
| Overall Survival (OS) | OS was defined as the period from the date of treatment initiation (Safety Run-in and Arm A) or randomization date (Arms B and C) to death due to any cause. For participants who are alive, OS was censored at the last contact. OS was calculated using Kaplan-Meier method. | Baseline until death due to any cause (assessed up to approximately 2.5 years) |
| Apparent Clearance (CL) of Venetoclax | CL is a quantitative measure of the rate at which a drug substance is removed from the body. | Pre-dose (within 30 minutes), and 2, 4, 6, 8 hours post-dose on Cycle 1 Day 1; pre-dose (within 30 minutes) on Cycle 1 Days 8, 15, 22; pre-dose (within 30 minutes) and 4 hours post-dose on Day 1 of Cycles 4 and 6 (Cycle length = 28 days) |
| Apparent Volume of Distribution (Vd) of Venetoclax | Vd was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. | Pre-dose (within 30 minutes), and 2, 4, 6, 8 hours post-dose on Cycle 1 Day 1; pre-dose (within 30 minutes) on Cycle 1 Days 8, 15, 22; pre-dose (within 30 minutes) and 4 hours post-dose on Day 1 of Cycles 4 and 6 (Cycle length = 28 days) |
| Time to Maximum Plasma Concentration (Tmax) of Venetoclax | Pre-dose (within 30 minutes), and 2, 4, 6, 8 hours post-dose on Cycle 1 Day 1; pre-dose (within 30 minutes) on Cycle 1 Days 8, 15, 22; pre-dose (within 30 minutes) and 4 hours post-dose on Day 1 of Cycles 4 and 6 (Cycle length = 28 days) |
| Maximum Plasma Concentration (Cmax) of Venetoclax | Pre-dose (within 30 minutes), and 2, 4, 6, 8 hours post-dose on Cycle 1 Day 1; pre-dose (within 30 minutes) on Cycle 1 Days 8, 15, 22; pre-dose (within 30 minutes) and 4 hours post-dose on Day 1 of Cycles 4 and 6 (Cycle length = 28 days) |
| Area Under the Plasma Concentration-Time Curve From Time 0 to Last Observed Concentration (AUClast) of Venetoclax | Area under the plasma concentration versus time curve from zero to the last measured concentration (AUClast). | Pre-dose (within 30 minutes), and 2, 4, 6, 8 hours post-dose on Cycle 1 Day 1; pre-dose (within 30 minutes) on Cycle 1 Days 8, 15, 22; pre-dose (within 30 minutes) and 4 hours post-dose on Day 1 of Cycles 4 and 6 (Cycle length = 28 days) |
| Area Under the Plasma Concentration-Time Curve From Time 0 to 8 Hours Post Dose (AUC0-8h) of Venetoclax | Area under the plasma concentration versus time curve from time 0 (pre-dose) to 8 hours post dose (AUC0-8h). | Pre-dose (within 30 minutes), and 2, 4, 6, 8 hours post-dose on Cycle 1 Day 1; pre-dose (within 30 minutes) on Cycle 1 Days 8, 15, 22; pre-dose (within 30 minutes) and 4 hours post-dose on Day 1 of Cycles 4 and 6 (Cycle length = 28 days) |
| Tucson |
| Arizona |
| 85719 |
| United States |
| UCLA School of Medicine; Hematology/Oncology | Los Angeles | California | 90095 | United States |
| Nothwest Georgia Oncology Centers P.C | Austell | Georgia | 30106 | United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| University of Illinois at Chicago College of Medicine | Chicago | Illinois | 60612-7302 | United States |
| Primary Healthcare Associates SC - Harvey | Harvey | Illinois | 60426 | United States |
| University of Kansas; Medical Center & Medical pavilion | Westwood | Kansas | 66205 | United States |
| Sidney Kimmel Comp Cancer Ctr | Baltimore | Maryland | 21231-1000 | United States |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| James P. Wilmot Cancer Center | Rochester | New York | 14642 | United States |
| University of Pennsylvania; School of Medicine | Philadelphia | Pennsylvania | 19104 | United States |
| Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | United States |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | United States |
| University of Virginia | Charlottesville | Virginia | 22903 | United States |
| VCU Massey Cancer Center | Richmond | Virginia | 23298-003 | United States |
| West Virginia Uni Med. Center - Robert Byrd Health Science | Morgantown | West Virginia | 26506 | United States |
| Royal Prince Alfred Hospital; Medical Oncology | Camperdown | New South Wales | 2050 | Australia |
| St George Hospital | Kogarah, New South Wales | New South Wales | 2217 | Australia |
| Royal North Shore Hospital | St Leonards | New South Wales | 2065 | Australia |
| Westmead Hospital; Haematology | Sydney | New South Wales | 2145 | Australia |
| Calvary Mater Newcastle | Waratah | New South Wales | 2298 | Australia |
| Townsville General Hospital | Douglas | Queensland | 4184 | Australia |
| Princess Alexandra Hospital | Woolloongabba | Queensland | 4102 | Australia |
| Queen Elizabeth Hospital; Haematology | Woodville South | South Australia | 5011 | Australia |
| Royal Hobart Hospital | Hobart | Tasmania | 7000 | Australia |
| Monash Medical Centre | Clayton | Victoria | 3168 | Australia |
| ZNA Stuivenberg | Antwerp | 2060 | Belgium |
| AZ Sint Jan | Bruges | 8000 | Belgium |
| Cliniques Universitaires St-Luc | Brussels | 1200 | Belgium |
| Cross Cancer Institute | Edmonton | Alberta | T6G 1Z2 | Canada |
| British Columbia Cancer Agency | Kelowna | British Columbia | V1Y 5L3 | Canada |
| University Health Network; Princess Margaret Hospital; Medical Oncology Dept | Toronto | Ontario | M5G 2M9 | Canada |
| Hopital Maisonneuve- Rosemont; Oncology | Montreal | Quebec | H1T 2M4 | Canada |
| Chum Hopital Notre Dame; Centre D'Oncologie | Montreal | Quebec | H2L 4M1 | Canada |
| Jewish General Hospital | Montreal | Quebec | H3T 1E2 | Canada |
| Saskatoon Cancer Centre; Uni of Saskatoon Campus | Saskatoon | Saskatchewan | S7N 4H4 | Canada |
| Institut de Cancerologie de l'Ouest | Angers | 49933 | France |
| CHU Clermont Ferrand - Hôpital d'Estaing | Clermont-Ferrand | 63003 | France |
| Hopital Henri Mondor | Créteil | 94010 | France |
| CHU de Dijon - Hopital le Bocage | Dijon | 21000 | France |
| Centre Jean Bernard | Le Mans | 72015 | France |
| CHU Montpellier | Montpellier | 34295 | France |
| Centre Hospitalier Lyon Sud; Hematolgie | Pierre-Bénite | 69495 | France |
| Klinikum Chemnitz gGmbH; Klinik f. Innere Medizin III | Chemnitz | 09116 | Germany |
| Universitätsklinikum Köln; Klinik I für Innere Medizin | Cologne | 50937 | Germany |
| Städtisches Klinikum Dessau | Dessau | 06847 | Germany |
| BAG Freiberg-Richter, Jacobasch, Illmer, Wolf; Gemeinschaftspraxis Hämatologie-Onkologie | Dresden | 01307 | Germany |
| Universitätsklinik Essen; Klinik und Poliklinik für Dermatologie, Venerologie und Allergologie | Essen | 45122 | Germany |
| Universitätsklinikum Jena; Klinik für Innere Medizin II | Jena | 07747 | Germany |
| Universitätsklinikum Schleswig-Holstein / Campus Lübeck, Med. Klinik I, Hämatologie/Onkologie | Lübeck | 23562 | Germany |
| Uni. der Johannes Gutenberg-Universitaet Mainz; III. Medizinische Klinik und Poliklinik | Mainz | 55131 | Germany |
| Universitätsklinikum Ulm; Apotheke | Ulm | 89075 | Germany |
| Universitätsklinikum Würzburg; Medizinische Klinik und Poliklinik II; Hämatologie / Onkologie | Würzburg | 97080 | Germany |
| A.O. Universitaria Policlinico S.Orsola-Malpighi Di Bologna | Bologna | Emilia-Romagna | 40138 | Italy |
| IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica | Meldola | Emilia-Romagna | 47014 | Italy |
| Ospedale di Ravenna | Ravenna | Emilia-Romagna | 48100 | Italy |
| Ospedale Infermi di Rimini | Rimini | Emilia-Romagna | 47900 | Italy |
| Asst Papa Giovanni XXIII | Bergamo | Lombardy | 24100 | Italy |
| Ospedale Niguarda Milano | Milan | Lombardy | 20162 | Italy |
| Irccs Policlinico San Matteo; Divisione Di Ematologia | Pavia | Lombardy | 27100 | Italy |
| Azienda Ospedale San Giovanni | Turin | Piedmont | 10126 | Italy |
| Az. Osp. Di Careggi; Divisione Di Ematologia | Florence | Tuscany | 50135 | Italy |
| Blackpool Victoria Hospital | Blackpool | FY3 8NR | United Kingdom |
| St James University Hospital | Leeds | LS9 7TF | United Kingdom |
| Leicester Royal Infirmary; Dept. of Medical Oncology | Leicester | LE1 5WW | United Kingdom |
| University College London, Department of Haematology | London | NW1 2PG | United Kingdom |
| Royal Marsden Nhs Trust; Consultant Cancer Physician | London | SW3 6JJ | United Kingdom |
| Christie Hospital; Breast Cancer Research Office | Manchester | M20 4QL | United Kingdom |
| Churchill Hospital; Oxford Cancer and Haematology Centre | Oxford | OX3 7LJ | United Kingdom |
| Royal Marsden NHS Foundation Trust | Sutton | SM2 5PT | United Kingdom |
| FG001 | Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab) | Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days. |
| FG002 | Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR) | Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles. |
| FG003 | Chemotherapy-Containing Cohort: Arm C (BR) | Participants received rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles. |
| Treated |
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| COMPLETED |
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| NOT COMPLETED |
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Intent-to-treat (ITT) population included all enrolled participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR) | Participants received venetoclax no more than 600 milligrams (mg) orally once daily continuously along with rituximab 375 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of the 28-day cycle. Safety run-in continued until first 9 participants completed the safety observation window of 28 days. After first 28 days of safety observation (Cycle 1), participants continued to receive venetoclax 600 mg orally once daily up to 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles. |
| BG001 | Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab) | Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days. |
| BG002 | Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR) | Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles. |
| BG003 | Chemotherapy-Containing Cohort: Arm C (BR) | Participants received rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| 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 |
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| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Percentage of Participants With Complete Metabolic Response (CMR) According to Independent Review Committee (IRC) as Per Lugano Classification, Using Positron Emission Tomography (PET) Scan at Primary Response Assessment (PRA) | CMR: a score 1 (no uptake above background), 2 (uptake less than or equal to [<=] mediastinum), or 3 (uptake less than [<] mediastinum but <=liver) with or without a residual mass on PET 5-point scale (5-PS), for lymph nodes and extralymphatic sites with no new lesions and no evidence of fluorodeoxyglucose (FDG)-avid disease in bone marrow. Assessment was performed by an IRC according to Lugano classification using PET scan. 95% confidence interval (CI) for percentage of responders was calculated using Clopper-Pearson method. | ITT population | Posted | Number | 95% Confidence Interval | percentage of participants | 6-8 weeks after Cycle 6 Day 1 (PRA) (Cycle length = 28 days) |
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| Secondary | Percentage of Participants With CMR According to Investigator as Per Lugano Classification, Using PET Scan at PRA | CMR: a score 1 (no uptake above background), 2 (uptake <=mediastinum), or 3 (\ | ITT population | Posted | Number | 95% Confidence Interval | percentage of participants | 4-10 weeks after Cycle 6 Day 1 (Cycle length = 28 days) |
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| Secondary | Percentage of Participants With CMR According to IRC as Per Lugano Classification, Using PET Scan at Year 1 | CMR: a score 1 (no uptake above background), 2 (uptake <=mediastinum), or 3 (uptake \ | ITT population | Posted | Number | 95% Confidence Interval | percentage of participants | 48-56 weeks after Cycle 1 Day 1 (Cycle length = 28 days) |
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| Secondary | Percentage of Participants With CMR According to Investigator as Per Lugano Classification, Using PET Scan at Year 1 | CMR: a score 1 (no uptake above background), 2 (uptake <=mediastinum), or 3 (\ | ITT population | Posted | Number | 95% Confidence Interval | percentage of participants | 48-56 weeks after Cycle 1 Day 1 (Cycle length = 28 days) |
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| Secondary | Percentage of Participants With Complete Response (CR) According to IRC as Per Lugano Classification, Using Computed Tomography (CT) Scan | CR: defined as reduction of longest transverse diameter of lesion (LDi) of target nodes/nodal masses to <=1.5 centimeters (cm), and no extralymphatic sites of disease; absence of non-measured lesions and new lesions; reduction of enlarged organs to normal; and normal/immunohistochemistry (IHC)-negative bone marrow morphology. Assessment was performed by an IRC according to Lugano classification using CT scan. 95% CI for percentage of responders was calculated using Clopper-Pearson method. | ITT population | Posted | Number | 95% Confidence Interval | percentage of participants | 6-8 weeks after Cycle 6 Day 1 and 48-56 weeks after Cycle 1 Day 1 (Cycle length = 28 days) |
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| Secondary | Percentage of Participants With CR According to Investigator as Per Lugano Classification, Using CT Scan | CR: defined as reduction of LDi of target nodes/nodal masses to <=1.5 cm, and no extralymphatic sites of disease; absence of non-measured lesions and new lesions; reduction of enlarged organs to normal; and normal/IHC-negative bone marrow morphology. Assessment was performed by Investigator according to Lugano classification using CT scan. 95% CI for percentage of responders was calculated using Clopper-Pearson method. | ITT population | Posted | Number | 95% Confidence Interval | percentage of participants | 4-10 weeks after Cycle 6 Day 1 and 48-56 weeks after Cycle 1 Day 1 (Cycle length = 28 days) |
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| Secondary | Percentage of Participants With Objective Response (OR) According to IRC as Per Lugano Classification, Using PET Scan | OR was defined as CMR or Partial Metabolic Response (PMR). CMR: a score 1 (no uptake above background), 2 (uptake <=mediastinum), or 3 (<mediastinum but <=liver) with or without a residual mass on PET 5-PS, for lymph nodes and extralymphatic sites with no new lesions and no evidence of FDG-avid disease in bone marrow. PMR: a score 4 (uptake moderately greater than [>] liver) or 5 (uptake markedly >liver and/or new lesions) with reduced uptake compared with baseline and residual mass(es) of any size on PET 5-PS for lymph nodes and extralymphatic sites with no new lesions and reduced residual uptake in bone marrow compared with baseline. Assessment was performed by an IRC according to Lugano classification using PET scan. 95% CI for percentage of responders was calculated using Clopper-Pearson method. | ITT population | Posted | Number | 95% Confidence Interval | percentage of participants | 6-8 weeks after Cycle 6 Day 1 and 48-56 weeks after Cycle 1 Day 1 (Cycle length = 28 days) |
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| Secondary | Percentage of Participants With OR According to Investigator as Per Lugano Classification, Using PET Scan | OR was defined as CMR or PMR. CMR: a score 1 (no uptake above background), 2 (uptake <=mediastinum), or 3 (<mediastinum but <=liver) with or without a residual mass on PET 5-PS, for lymph nodes and extralymphatic sites with no new lesions and no evidence of FDG-avid disease in bone marrow. PMR: a score 4 (uptake moderately >liver) or 5 (uptake markedly >liver and/or new lesions) with reduced uptake compared with baseline and residual mass(es) of any size on PET 5-PS for lymph nodes and extralymphatic sites with no new lesions and reduced residual uptake in bone marrow compared with baseline. Assessment was performed by Investigator according to Lugano classification using PET scan. 95% CI for percentage of responders was calculated using Clopper-Pearson method. | ITT population | Posted | Number | 95% Confidence Interval | percentage of participants | 4-10 weeks after Cycle 6 Day 1 and 48-56 weeks after Cycle 1 Day 1 (Cycle length = 28 days) |
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| Secondary | Percentage of Participants With OR According to IRC as Per Lugano Classification, Using CT Scan | OR was defined as CR or Partial Response (PR). CR: reduction of LDi of target nodes/nodal masses to <=1.5 cm, and no extralymphatic sites of disease; absence of non-measured lesions and new lesions; reduction of enlarged organs to normal; and normal/IHC-negative bone marrow morphology. PR: greater than or equal to (>=) 50 percent (%) decrease in sum of the product of the perpendicular diameters (SPD) of up to 6 target measurable nodes and extra-nodal sites; absence/reduction/no increase in size of non-measured lesions; reduction in length of spleen at least >50% beyond normal; and no new lesions. Assessment was performed by an IRC according to Lugano classification using CT scan. 95% CI for percentage of responders was calculated using Clopper-Pearson method. | ITT population | Posted | Number | 95% Confidence Interval | percentage of participants | 6-8 weeks after Cycle 6 Day 1 and 48-56 weeks after Cycle 1 Day 1 (Cycle length = 28 days) |
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| Secondary | Percentage of Participants With OR According to Investigator as Per Lugano Classification, Using CT Scan | OR was defined as CR or PR. CR: reduction of LDi of target nodes/nodal masses to <=1.5 cm, and no extralymphatic sites of disease; absence of non-measured lesions and new lesions; reduction of enlarged organs to normal; and normal/IHC-negative bone marrow morphology. PR: >=50% decrease in SPD of up to 6 target measurable nodes and extra-nodal sites; absence/reduction/no increase in size of non-measured lesions; reduction in length of spleen at least >50% beyond normal; and no new lesions. Assessment was performed by Investigator according to Lugano classification using CT scan. 95% CI for percentage of responders was calculated using Clopper-Pearson method. | ITT population | Posted | Number | 95% Confidence Interval | percentage of participants | 4-10 weeks after Cycle 6 Day 1 and 48-56 weeks after Cycle 1 Day 1 (Cycle length = 28 days) |
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| Secondary | Percentage of Participants With OR According to Investigator as Per Lugano Classification, Using PET or CT Scan | OR was defined as CMR/CR or PMR/PR. CMR, CR, PMR, and PR have been defined in previous endpoints, and are not repeated here due to space constraint. Assessment was performed by Investigator according to Lugano classification using PET scan or CT scan (if PET is missing). | ITT population. 'Overall number of participants analyzed'=those evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline until disease progression or death due to any cause (assessed up to approximately 2.5 years) |
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| Secondary | Duration of Response (DOR) According to Investigator as Per Lugano Classification, Using PET or CT Scan | DOR was defined as time from CMR/CR or PMR/PR until progressive disease (PD) or death due to any cause. CMR, CR, PMR, and PR have been defined in previous endpoints, and are not repeated here due to space constraint. PD: a score 4 (uptake moderately >liver) or 5 (uptake markedly >liver and/or new lesions) with increase in intensity of uptake from baseline on PET 5-PS for individual target nodes/nodal lesions; new FDG-avid foci for extranodal lesions; new FDG-avid foci consistent with lymphoma for new lesions; or new or recurrent FDG-avid foci for bone marrow. Assessment was performed by Investigator according to Lugano classification using PET scan or CT scan (if PET is missing). DOR was calculated using Kaplan-Meier method. | ITT population. 'Overall number of participants analyzed'=those evaluable for this outcome measure. | Posted | Median | 95% Confidence Interval | months | From CMR or PMR until disease progression or death due to any cause (assessed up to approximately 2.5 years) |
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| Secondary | Percentage of Participants With Disease Progression (According to Investigator as Per Lugano Classification, Using PET or CT Scan) or Death | PD: a score 4 (uptake moderately >liver) or 5 (uptake markedly >liver and/or new lesions) with increase in intensity of uptake from baseline on PET 5-PS for individual target nodes/nodal lesions; new FDG-avid foci for extranodal lesions; new FDG-avid foci consistent with lymphoma for new lesions; or new or recurrent FDG-avid foci for bone marrow. Assessment was performed by Investigator according to Lugano classification using PET or CT scan. | ITT population | Posted | Number | percentage of participants | Baseline until disease progression or death due to any cause (assessed up to approximately 2.5 years) |
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| Secondary | Progression-Free Survival (PFS) According to Investigator as Per Lugano Classification, Using PET or CT Scan | PFS was defined as the period from the date of treatment initiation (Safety Run-in and Arm A) or randomization date (Arms B and C) until the date of disease progression, or death due to any cause. PD: a score 4 (uptake moderately >liver) or 5 (uptake markedly >liver and/or new lesions) with increase in intensity of uptake from baseline on PET 5-PS for individual target nodes/nodal lesions; new FDG-avid foci for extranodal lesions; new FDG-avid foci consistent with lymphoma for new lesions; or new or recurrent FDG-avid foci for bone marrow. Assessment was performed by Investigator according to Lugano classification using PET or CT scan. PFS was calculated using Kaplan-Meier method. | ITT population | Posted | Median | 95% Confidence Interval | months | Baseline until disease progression or death due to any cause (assessed up to approximately 2.5 years) |
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| Secondary | Percentage of Participants With Disease Progression (According to Investigator as Per Lugano Classification, Using PET or CT Scan), Death, or Start of a New Anti-lymphoma Therapy | PD: a score 4 (uptake moderately >liver) or 5 (uptake markedly >liver and/or new lesions) with increase in intensity of uptake from baseline on PET 5-PS for individual target nodes/nodal lesions; new FDG-avid foci for extranodal lesions; new FDG-avid foci consistent with lymphoma for new lesions; or new or recurrent FDG-avid foci for bone marrow. Assessment was performed by Investigator according to Lugano classification using PET or CT scan. | ITT population | Posted | Number | percentage of participants | Baseline until disease progression, death, or start of a new anti-lymphoma therapy whichever occurred first (assessed up to approximately 2.5 years) |
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| Secondary | Event-Free Survival (EFS) According to Investigator as Per Lugano Classification, Using PET or CT Scan | EFS was defined as the period from the date of treatment initiation (Safety Run-in and Arm A) or randomization date (Arms B and C) to the date of disease progression, death, or start of a new anti-lymphoma therapy whichever occurred first. PD: a score 4 (uptake moderately >liver) or 5 (uptake markedly >liver and/or new lesions) with increase in intensity of uptake from baseline on PET 5-PS for individual target nodes/nodal lesions; new FDG-avid foci for extranodal lesions; new FDG-avid foci consistent with lymphoma for new lesions; or new or recurrent FDG-avid foci for bone marrow. Assessment was performed by Investigator according to Lugano classification using PET or CT scan. EFS was calculated using Kaplan-Meier method. | ITT population | Posted | Median | 95% Confidence Interval | months | Baseline until disease progression, death, or start of a new anti-lymphoma therapy whichever occurred first (assessed up to approximately 2.5 years) |
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| Secondary | Percentage of Participants Who Died Due to Any Cause | ITT population | Posted | Number | percentage of participants | Baseline until death due to any cause (assessed up to approximately 2.5 years |
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| Secondary | Overall Survival (OS) | OS was defined as the period from the date of treatment initiation (Safety Run-in and Arm A) or randomization date (Arms B and C) to death due to any cause. For participants who are alive, OS was censored at the last contact. OS was calculated using Kaplan-Meier method. | ITT population | Posted | Median | 95% Confidence Interval | months | Baseline until death due to any cause (assessed up to approximately 2.5 years) |
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| Secondary | Apparent Clearance (CL) of Venetoclax | CL is a quantitative measure of the rate at which a drug substance is removed from the body. | The data could not be collected as the timepoints for pharmacokinetics collection and the daily dosing of venetoclax did not permit an assessment of CL. | Posted | Pre-dose (within 30 minutes), and 2, 4, 6, 8 hours post-dose on Cycle 1 Day 1; pre-dose (within 30 minutes) on Cycle 1 Days 8, 15, 22; pre-dose (within 30 minutes) and 4 hours post-dose on Day 1 of Cycles 4 and 6 (Cycle length = 28 days) |
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| Secondary | Apparent Volume of Distribution (Vd) of Venetoclax | Vd was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. | The data could not be collected as the timepoints for pharmacokinetics collection and the daily dosing of venetoclax did not permit an assessment of Vd. | Posted | Pre-dose (within 30 minutes), and 2, 4, 6, 8 hours post-dose on Cycle 1 Day 1; pre-dose (within 30 minutes) on Cycle 1 Days 8, 15, 22; pre-dose (within 30 minutes) and 4 hours post-dose on Day 1 of Cycles 4 and 6 (Cycle length = 28 days) |
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| Secondary | Time to Maximum Plasma Concentration (Tmax) of Venetoclax | Pharmacokinetic-evaluable population included all enrolled participants with available pharmacokinetic data for venetoclax. | Posted | Median | Full Range | hours | Pre-dose (within 30 minutes), and 2, 4, 6, 8 hours post-dose on Cycle 1 Day 1; pre-dose (within 30 minutes) on Cycle 1 Days 8, 15, 22; pre-dose (within 30 minutes) and 4 hours post-dose on Day 1 of Cycles 4 and 6 (Cycle length = 28 days) |
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| Secondary | Maximum Plasma Concentration (Cmax) of Venetoclax | Pharmacokinetic-evaluable population | Posted | Mean | Standard Deviation | nanograms per milliliter (ng/mL) | Pre-dose (within 30 minutes), and 2, 4, 6, 8 hours post-dose on Cycle 1 Day 1; pre-dose (within 30 minutes) on Cycle 1 Days 8, 15, 22; pre-dose (within 30 minutes) and 4 hours post-dose on Day 1 of Cycles 4 and 6 (Cycle length = 28 days) |
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| Secondary | Area Under the Plasma Concentration-Time Curve From Time 0 to Last Observed Concentration (AUClast) of Venetoclax | Area under the plasma concentration versus time curve from zero to the last measured concentration (AUClast). | Pharmacokinetic-evaluable population | Posted | Mean | Standard Deviation | hours*ng/mL | Pre-dose (within 30 minutes), and 2, 4, 6, 8 hours post-dose on Cycle 1 Day 1; pre-dose (within 30 minutes) on Cycle 1 Days 8, 15, 22; pre-dose (within 30 minutes) and 4 hours post-dose on Day 1 of Cycles 4 and 6 (Cycle length = 28 days) |
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| Secondary | Area Under the Plasma Concentration-Time Curve From Time 0 to 8 Hours Post Dose (AUC0-8h) of Venetoclax | Area under the plasma concentration versus time curve from time 0 (pre-dose) to 8 hours post dose (AUC0-8h). | Pharmacokinetic-evaluable population. 'Overall number of participants analyzed'=those evaluable for this outcome measure. | Posted | Mean | Standard Deviation | hours*ng/mL | Pre-dose (within 30 minutes), and 2, 4, 6, 8 hours post-dose on Cycle 1 Day 1; pre-dose (within 30 minutes) on Cycle 1 Days 8, 15, 22; pre-dose (within 30 minutes) and 4 hours post-dose on Day 1 of Cycles 4 and 6 (Cycle length = 28 days) |
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Baseline up to approximately 2.5 years
Safety-evaluable population included participants who received at least one dose of any study treatment.
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 | Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR) | Participants received venetoclax no more than 600 milligrams (mg) orally once daily continuously along with rituximab 375 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of the 28-day cycle. Safety run-in continued until first 9 participants completed the safety observation window of 28 days. After first 28 days of safety observation (Cycle 1), participants continued to receive venetoclax 600 mg orally once daily up to 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles. | 4 | 9 | 9 | 9 | ||
| EG001 | Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab) | Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days. | 16 | 52 | 49 | 52 | ||
| EG002 | Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR) | Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles. | 26 | 49 | 49 | 49 | ||
| EG003 | Chemotherapy-Containing Cohort: Arm C (BR) | Participants received rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles. | 12 | 50 | 48 | 50 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 21.0 | Non-systematic Assessment |
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| Aplastic anaemia | Blood and lymphatic system disorders | MedDRA Version 21.0 | Non-systematic Assessment |
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| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA Version 21.0 | Non-systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA Version 21.0 | Non-systematic Assessment |
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| Acute left ventricular failure | Cardiac disorders | MedDRA Version 21.0 | Non-systematic Assessment |
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| Cardiac failure | Cardiac disorders | MedDRA Version 21.0 | Non-systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA Version 21.0 | Non-systematic Assessment |
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| Diplopia | Eye disorders | MedDRA Version 21.0 | Non-systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA Version 21.0 | Non-systematic Assessment |
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| Colitis | Gastrointestinal disorders | MedDRA Version 21.0 | Non-systematic Assessment |
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| Erosive oesophagitis | Gastrointestinal disorders | MedDRA Version 21.0 | Non-systematic Assessment |
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| Pancreatitis | Gastrointestinal disorders | MedDRA Version 21.0 | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA Version 21.0 | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA Version 21.0 | Non-systematic Assessment |
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| Cholecystitis chronic | Hepatobiliary disorders | MedDRA Version 21.0 | Non-systematic Assessment |
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| Cholelithiasis | Hepatobiliary disorders | MedDRA Version 21.0 | Non-systematic Assessment |
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| Cytokine release syndrome | Immune system disorders | MedDRA Version 21.0 | Non-systematic Assessment |
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| Acute sinusitis | Infections and infestations | MedDRA Version 21.0 | Non-systematic Assessment |
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| Atypical pneumonia | Infections and infestations | MedDRA Version 21.0 | Non-systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA Version 21.0 | Non-systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA Version 21.0 | Non-systematic Assessment |
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| Clostridium difficile colitis | Infections and infestations | MedDRA Version 21.0 | Non-systematic Assessment |
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| Cystitis | Infections and infestations | MedDRA Version 21.0 | Non-systematic Assessment |
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| Cytomegalovirus infection | Infections and infestations | MedDRA Version 21.0 | Non-systematic Assessment |
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| Device related infection | Infections and infestations | MedDRA Version 21.0 | Non-systematic Assessment |
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| Diverticulitis | Infections and infestations | MedDRA Version 21.0 | Non-systematic Assessment |
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| Herpes zoster disseminated | Infections and infestations | MedDRA Version 21.0 | Non-systematic Assessment |
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| Lower respiratory tract infection | Infections and infestations | MedDRA Version 21.0 | Non-systematic Assessment |
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| Lung infection | Infections and infestations | MedDRA Version 21.0 | Non-systematic Assessment |
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| Oesophageal candidiasis | Infections and infestations | MedDRA Version 21.0 | Non-systematic Assessment |
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| Pneumocystis jirovecii pneumonia | Infections and infestations | MedDRA Version 21.0 | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA Version 21.0 | Non-systematic Assessment |
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| Pneumonia pseudomonal | Infections and infestations | MedDRA Version 21.0 | Non-systematic Assessment |
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| Pyelonephritis | Infections and infestations | MedDRA Version 21.0 | Non-systematic Assessment |
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| Respiratory syncytial virus infection | Infections and infestations | MedDRA Version 21.0 | Non-systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA Version 21.0 | Non-systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA Version 21.0 | Non-systematic Assessment |
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| Skin infection | Infections and infestations | MedDRA Version 21.0 | Non-systematic Assessment |
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| Viral infection | Infections and infestations | MedDRA Version 21.0 | Non-systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA Version 21.0 | Non-systematic Assessment |
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| Blood creatine phosphokinase increased | Investigations | MedDRA Version 21.0 | Non-systematic Assessment |
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| Blood lactate dehydrogenase increased | Investigations | MedDRA Version 21.0 | Non-systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA Version 21.0 | Non-systematic Assessment |
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| Tumour lysis syndrome | Metabolism and nutrition disorders | MedDRA Version 21.0 | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Version 21.0 | Non-systematic Assessment |
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| Adenocarcinoma of colon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 21.0 | Non-systematic Assessment |
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| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 21.0 | Non-systematic Assessment |
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| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 21.0 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA Version 21.0 | Non-systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA Version 21.0 | Non-systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA Version 21.0 | Non-systematic Assessment |
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| Acute kidney injury | Renal and urinary disorders | MedDRA Version 21.0 | Non-systematic Assessment |
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| Renal colic | Renal and urinary disorders | MedDRA Version 21.0 | Non-systematic Assessment |
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| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.0 | Non-systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.0 | Non-systematic Assessment |
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| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.0 | Non-systematic Assessment |
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| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.0 | Non-systematic Assessment |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.0 | Non-systematic Assessment |
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| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.0 | Non-systematic Assessment |
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| Urticaria | Skin and subcutaneous tissue disorders | MedDRA Version 21.0 | Non-systematic Assessment |
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| Renal stone removal | Surgical and medical procedures | MedDRA Version 21.0 | Non-systematic Assessment |
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| Embolism | Vascular disorders | MedDRA Version 21.0 | Non-systematic Assessment |
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| Haemorrhage | Vascular disorders | MedDRA Version 21.0 | Non-systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA Version 21.0 | Non-systematic Assessment |
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| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA Version 21.0 | Non-systematic Assessment |
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| ACUTE CORONARY SYNDROME | Cardiac disorders | MedDRA Version 21.0 | Non-systematic Assessment |
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| LEFT VENTRICULAR FAILURE | Cardiac disorders | MedDRA Version 21.0 | Non-systematic Assessment |
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| HERPES SIMPLEX | Infections and infestations | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| LUNG ADENOCARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| METASTATIC MALIGNANT MELANOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA Version 21.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Large intestine polyp | Gastrointestinal disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Catheter site pain | General disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Mass | General disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Aspergillus infection | Infections and infestations | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Mycobacterium kansasii infection | Infections and infestations | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Perineal abscess | Infections and infestations | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Weight increased | Investigations | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Periarthritis | Musculoskeletal and connective tissue disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Burning sensation | Nervous system disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Hallucination | Psychiatric disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Renal colic | Renal and urinary disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Lung consolidation | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Yellow skin | Skin and subcutaneous tissue disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| SUBCUTANEOUS ABSCESS | Infections and infestations | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| COGNITIVE DISORDER | Nervous system disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| BASAL CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| COLON ADENOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| HYPOGAMMAGLOBULINAEMIA | Immune system disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| OEDEMA PERIPHERAL | General disorders | MedDRA Version 21.0 | 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-La Roche | 800-821-8590 | genentech@druginfo.com |
| ID | Term |
|---|---|
| D008224 | Lymphoma, Follicular |
| 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 |
|---|---|
| C579720 | venetoclax |
| D000069461 | Bendamustine Hydrochloride |
| D000069283 | Rituximab |
| 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 |
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| Male |
|
Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days. |
| OG002 | Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR) | Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles. |
| OG003 | Chemotherapy-Containing Cohort: Arm C (BR) | Participants received rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles. |
|
|
|
Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days. |
| OG002 | Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR) | Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles. |
| OG003 | Chemotherapy-Containing Cohort: Arm C (BR) | Participants received rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles. |
|
|
|
Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days. |
| OG002 | Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR) | Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles. |
| OG003 | Chemotherapy-Containing Cohort: Arm C (BR) | Participants received rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles. |
|
|
|
| Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab) |
Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days. |
| OG002 | Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR) | Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles. |
| OG003 | Chemotherapy-Containing Cohort: Arm C (BR) | Participants received rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles. |
|
|
|
Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days. |
| OG002 | Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR) | Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles. |
| OG003 | Chemotherapy-Containing Cohort: Arm C (BR) | Participants received rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles. |
|
|
|
| OG001 | Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab) | Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days. |
| OG002 | Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR) | Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles. |
| OG003 | Chemotherapy-Containing Cohort: Arm C (BR) | Participants received rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles. |
|
|
| OG001 | Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab) | Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days. |
| OG002 | Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR) | Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles. |
| OG003 | Chemotherapy-Containing Cohort: Arm C (BR) | Participants received rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles. |
|
|
| OG001 | Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab) | Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days. |
| OG002 | Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR) | Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles. |
| OG003 | Chemotherapy-Containing Cohort: Arm C (BR) | Participants received rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles. |
|
|
| OG001 | Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab) | Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days. |
| OG002 | Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR) | Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles. |
| OG003 | Chemotherapy-Containing Cohort: Arm C (BR) | Participants received rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles. |
|
|
Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days.
| OG002 | Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR) | Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles. |
| OG003 | Chemotherapy-Containing Cohort: Arm C (BR) | Participants received rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles. |
|
|
| OG001 | Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab) | Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days. |
| OG002 | Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR) | Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles. |
| OG003 | Chemotherapy-Containing Cohort: Arm C (BR) | Participants received rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles. |
|
|
|
Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days. |
| OG002 | Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR) | Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles. |
| OG003 | Chemotherapy-Containing Cohort: Arm C (BR) | Participants received rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles. |
|
|
| OG001 | Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab) | Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days. |
| OG002 | Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR) | Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles. |
| OG003 | Chemotherapy-Containing Cohort: Arm C (BR) | Participants received rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles. |
|
|
|
| OG001 |
| Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab) |
Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days. |
| OG002 | Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR) | Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles. |
| OG003 | Chemotherapy-Containing Cohort: Arm C (BR) | Participants received rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles. |
|
|
| OG001 | Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab) | Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days. |
| OG002 | Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR) | Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles. |
| OG003 | Chemotherapy-Containing Cohort: Arm C (BR) | Participants received rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles. |
|
|
|
Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles. |
| OG003 | Chemotherapy-Containing Cohort: Arm C (BR) | Participants received rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles. |
|
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| OG002 | Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR) | Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles. |
| OG003 | Chemotherapy-Containing Cohort: Arm C (BR) | Participants received rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles. |
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| OG002 | Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR) | Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles. |
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Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days.
| OG002 | Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR) | Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles. |
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| OG002 | Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR) | Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles. |
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| OG002 | Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR) | Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles. |
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| OG002 | Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR) | Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles. |
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Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days.
| OG002 | Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR) | Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles. |
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