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The primary objective of this study is to evaluate the efficacy of ibrutinib in combination with obinutuzumab compared to chlorambucil in combination with obinutuzumab based on the Independent Review Committee (IRC) assessment of progression free survival (PFS). Efficacy will be evaluated according to 2008 International Workshop for Chronic Lymphocytic Leukemia (IWCLL) criteria with the modification for treatment-related lymphocytosis, in subjects with treatment-naive CLL or SLL.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IBR + OB | Experimental | Ibrutinib (IBR) given orally at a dose of 420 mg/day until progressive disease or unacceptable toxicity. Intravenous obinutuzumab (OB) given on Days 1 and 2 (100 mg on Day 1 and 900 mg on Day 2), 1000 mg on Days 8 and 15 of Cycle 1 and 1000 mg on Day 1 of each cycle up to 6 cycles or until progressive disease or unacceptable toxicity. |
|
| CLB + OB | Experimental | Chlorambucil (CLB) given orally at a dose of 0.5 mg/kg body weight up to a total of 6 cycles on Days 1 and 15 of each cycle or until disease progression or unacceptable toxicity. Intravenous obinutuzumab given on Days 1 and 2 (100 mg on Day 1 and 900 mg on Day 2), 1000 mg on Days 8 and 15 of Cycle 1 and 1000 mg on Day 1 of each cycle up to 6 cycles or until disease progression or unacceptable toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ibrutinib | Drug | Ibrutinib will be supplied as 140 mg hard gelatin capsules for oral (PO) administration. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Analysis: Progression Free Survival (PFS) Based on Independent Review Committee (IRC) Assessment - Kaplan Meier Landmark Estimates at Month 30 | PFS was defined as time from the date randomization to the date of first IRC-confirmed disease progression (PD) or date of death due to any cause, whichever occurred first, regardless of the use of subsequent antineoplastic therapy prior to documented PD or death. Assessment of PD was conducted in accordance with the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 criteria (Halleck et al) with the modification that treatment-related lymphocytosis in the absence of other signs or symptoms of disease progression was not considered progressive disease. The primary analysis was performed after observing 94 PFS events as pre-specified in the study protocol. As the median PFS was not reached in the experimental (IBR+OB) arm at the time of the analysis, Kaplan Meier landmark estimates of the PFS rate at 30 months (that is, the estimated percentage of participants with progression-free survival at Month 30) are presented. | Month 30 (Median follow-up time was 31.3 months at the time of the primary analysis [data cutoff date: 26 March 2018]). |
| Final Analysis: PFS Based on Investigator Assessment - Kaplan Meier Landmark Estimates at Month 48 | PFS was defined as time from the date randomization to the date of first investigator-confirmed PD or date of death due to any cause, whichever occurred first, regardless of the use of subsequent antineoplastic therapy prior to documented PD or death. Assessment of PD was conducted in accordance with the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 criteria (Halleck et al) with the modification that treatment-related lymphocytosis in the absence of other signs or symptoms of disease progression was not considered progressive disease. As the median PFS was not reached in the experimental (IBR+OB) arm at the time of the analysis, Kaplan Meier landmark estimates of the PFS rate at 48 months (that is, the estimated percentage of participants with progression-free survival at Month 48) are presented. | Month 48 (Median follow-up time was 44.6 months at the time of the final analysis [data cutoff date: 17 October 2019]). |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Analysis: PFS in High-Risk Sub-Population (del17p/TP53 Mutation/Del 11q) Based on IRC Assessment - Kaplan Meier Landmark Estimates at Month 30 | PFS was analyzed within the high-risk sub-population of participants with del17p or TP53 mutation or del 11q at baseline per central lab results. PFS was defined as time from the date randomization to the date of first IRC-confirmed PD or date of death due to any cause, whichever occurred first, regardless of the use of subsequent antineoplastic therapy prior to documented PD or death. Assessment of PD was conducted in accordance with the IWCLL 2008 criteria (Halleck et al) with the modification that treatment-related lymphocytosis in the absence of other signs or symptoms of PD was not considered progressive disease. As the median PFS was not reached in the experimental (IBR+OB) arm at the time of the analysis, Kaplan Meier landmark estimates of the PFS rate at 30 months (that is, the estimated percentage of participants with progression-free survival at Month 30) are presented. |
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Inclusion Criteria:
Disease Related:
Diagnosis of CLL/SLL that meets IWCLL diagnostic criteria.
Age 65 yrs and older OR if less than 65 years, must have at least one of the following criteria:
Active disease meeting at least 1 of the following IWCLL criteria for requiring treatment:
Measurable nodal disease by computed tomography (CT), defined as at least 1 lymph node >1.5 cm in the longest diameter in a site that has not been previously irradiated. An irradiated lesion may be assessed for measurable disease only if there has been documented progression in that lesion since radiotherapy has ended.
Laboratory
Adequate hematologic function independent of transfusion and growth factor support for at least 7 days prior to screening and randomization.
Adequate hepatic and renal function
Men and women ≥ 18 years of age.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
Exclusion Criteria:
Any prior treatment of CLL or SLL
Evidence of central nervous system (CNS) involvement with primary disease of CLL/SLL
History of other malignancies, except:
Uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenic purpura
Known or suspected history of Richter's transformation.
Concurrent administration of >20mg/day of prednisone within 7 days of randomization unless indicated for prophylaxis or management of allergic reactions (eg, contrast)
Known hypersensitivity to one or more study drugs
Vaccinated with live, attenuated vaccines within 4 weeks of first dose of study drug.
Any uncontrolled active systemic infection or an infection requiring systemic treatment that was completed ≤ 7 days before randomization.
Known bleeding disorders or hemophilia.
History of stroke or intracranial hemorrhage within 6 months prior to enrollment.
Known history of human immunodeficiency virus (HIV) or active with hepatitis B virus (HBV) or hepatitis C virus (HCV).
Major surgery within 4 weeks of randomization.
Any life-threatening illness, medical condition, or organ system dysfunction that, in the investigator's opinion, could compromise the subject's safety or put the study outcomes at undue risk.
Currently active, clinically significant cardiovascular disease, such as uncontrolled arrhythmia or Class 3 or 4 congestive heart failure or a history of myocardial infarction, unstable angina, or acute coronary syndrome within 6 months prior to randomization.
Unable to swallow capsules or malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel, symptomatic inflammatory bowel disease or ulcerative colitis, or partial or complete bowel obstruction.
Concomitant use of warfarin or other vitamin K antagonists.
Requires treatment with a strong cytochrome P450 (CYP) 3A inhibitor.
Lactating or pregnant
Unwilling or unable to participate in all required study evaluations and procedures.
Unable to understand the purpose and risks of the study and to provide a signed and dated informed consent form (ICF) and authorization to use protected health information (in accordance with national and local subject privacy regulations).
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| Name | Affiliation | Role |
|---|---|---|
| Lori Styles | Pharmacyclics LLC. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 0241 | La Jolla | California | United States | |||
| Site Reference ID/Investigator# 0844 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30522969 | Result | Moreno C, Greil R, Demirkan F, Tedeschi A, Anz B, Larratt L, Simkovic M, Samoilova O, Novak J, Ben-Yehuda D, Strugov V, Gill D, Gribben JG, Hsu E, Lih CJ, Zhou C, Clow F, James DF, Styles L, Flinn IW. Ibrutinib plus obinutuzumab versus chlorambucil plus obinutuzumab in first-line treatment of chronic lymphocytic leukaemia (iLLUMINATE): a multicentre, randomised, open-label, phase 3 trial. Lancet Oncol. 2019 Jan;20(1):43-56. doi: 10.1016/S1470-2045(18)30788-5. Epub 2018 Dec 3. | |
| 40266025 |
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Requests for access to individual participant data from clinical studies conducted by Pharmacyclics LLC, an AbbVie Company, can be submitted through Yale Open Data Access (YODA) Project site at the following link.
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Eligible participants were required to have had a diagnosis of active CLL/SLL conformant to IWCLL 2008 criteria. All subjects were required to have measurable nodal disease. Key exclusion criteria included any previous CLL/SLL treatment; known lymphoma or leukemia of the central nervous system, history/current evidence of Richter's transformation.
This study was conducted in 71 sites: 8 in the US, 36 in the EU, and 27 sites in 6 additional countries (Canada, Australia, New Zealand, Russia, Israel, Turkey). The first participant consented 06 October 2014. The last visit of the last participant was 03 September 2019, with a final database lock of 17 October 2019.
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| ID | Title | Description |
|---|---|---|
| FG000 | IBR+OB | Ibrutinib (IBR) given orally at a dose of 420 mg/day until progressive disease or unacceptable toxicity. Intravenous obinutuzumab (OB) given on Days 1 and 2 (100 mg on Day 1 and 900 mg on Day 2), 1000 mg on Days 8 and 15 of Cycle 1 and 1000 mg on Day 1 of each cycle up to 6 cycles or until progressive disease or unacceptable toxicity. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 17, 2017 | Mar 20, 2019 |
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| Obinutuzumab | Drug | Obinutuzumab will be supplied as 1000 mg/40 mL solution in a single-use vial for intravenous (IV) administration |
|
| Chlorambucil | Drug | Chlorambucil will be supplied as 2 mg film-coated tablets for oral (PO) administration |
|
| Month 30 (Median follow-up time was 31.3 months at the time of the primary analysis [data cutoff date: 26 March 2018]). |
| Primary Analysis: Rate of Sustained Hemoglobin Improvement | Percentage of participants with sustained hemoglobin improvement, defined as hemoglobin increase ≥ 2 g/dL over baseline continuously for ≥ 56 days without blood transfusions or growth factors. | Median follow-up time was 31.3 months at the time of the primary analysis (data cutoff date: 26 March 2018). |
| Primary Analysis: Rate of Minimal Residual Disease (MRD)-Negative Response | Percentage of participants who achieved MRD-negative response, defined as < 1 CLL cell per 10,000 leukocytes as assessed by flow cytometry of a bone marrow aspirate per central laboratory. MRD samples were collected before initiation of subsequent antineoplastic treatment and MRD status was reported by central lab within 5 days after collection date. Participants with missing MRD data were considered non-responders. | Median follow-up time was 31.3 months at the time of the primary analysis (data cutoff date: 26 March 2018). |
| Primary Analysis: Overall Response Rate (ORR) Based on IRC Assessment | ORR, defined as the percentage of participants achieving a best overall response of protocol-specified complete response (CR), CR with incomplete blood count recovery (CRi), nodular partial response (nPR), or partial response (PR) per IRC assessment at or prior to initiation of subsequent antineoplastic therapy. Assessment of response included physical examination, radiographic imaging, and evaluation of blood and marrow (if applicable), evaluated in accordance with the IWCLL 2008 criteria (Halleck et al). CR, CRi, nPR, and PR required confirmation with 2 consecutive assessments that were at least 56 days apart and no use of blood supportive product and/or growth factor during this period. Kaplan-Meier estimate. | Median follow-up time was 31.3 months at the time of the primary analysis (data cutoff date: 26 March 2018). |
| Primary Analysis: Overall Survival (OS) - Kaplan Meier Landmark Estimates at Month 30 | OS, defined as the time from the date of randomization to the date of death from any cause. All deaths observed as the time of the analysis were considered as events. For participants who were not known to have died at the time of the analysis, OS data were censored at the date last known alive. As the median OS was not reached in either treatment arm at the time of the analysis, Kaplan Meier landmark estimates of the OS rate (that is, the estimated percentage of participants still surviving at Month 30 [primary analysis]) are presented. | Month 30 (Median follow-up time was 31.3 months at the time of the primary analysis [data cutoff date: 26 March 2018]). |
| Primary Analysis: Rate of Grade ≥ 3 or Serious Infusion-Related Reaction (IRR) Adverse Events | Percentage of participants experiencing grade ≥ 3 (severe or life threatening) or serious IRR adverse events that started on the day of an obinutuzumab infusion and were assessed as related or possibly related to obinutuzumab. Categories included those events with the Medical Dictionary for Regulatory Activities (MedDRA) dictionary preferred term of IRR and those events which are among the customized standardized MedDRA query (SMQ) for IRR. | Median follow-up time was 31.3 months at the time of the primary analysis (data cutoff date: 26 March 2018). |
| Primary Analysis: Rate of Sustained Platelet Improvement | Percentage of participants with platelet counts increase ≥ 50% over baseline continuously for ≥ 56 days without blood transfusion or growth factors. | Median follow-up time was 31.3 months at the time of the primary analysis (data cutoff date: 26 March 2018). |
| Primary Analysis: Rate of Clinically Meaningful Improvement in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire EuroQol Five-Dimension (EQ-5D-5L) | Percentage of participants with EQ-5D-5L utility score increase ≥ 0.08 points over baseline at or prior to initiation of subsequent antineoplastic therapy. The EQ-5D-5L is a standardized non-disease specific instrument for describing and valuing health-related quality of life, comprising 5 dimensions of health (mobility, self -care, usual activities, pain/discomfort, and anxiety/depression) to describe the participant's current health state. Each dimension comprises 5 levels with corresponding numeric scores, where 1 indicates no problems, and 5 indicates extreme problems. A unique EQ-5D-5L health state is defined by combining the numeric level scores for each of the 5 dimensions and the total score is normalized from -0.594 to 1.000, with higher scores representing a better health state. An increase in the EQ-5D-5L total score indicates improvement. Participants with missing EQ-5D-5L data were considered not achieving clinically meaningful improvement. | Median follow-up time was 31.3 months at the time of the primary analysis (data cutoff date: 26 March 2018). |
| Final Analysis: PFS in High-Risk Population (del17p/TP53 Mutation/Del 11q/Unmutated Immunoglobulin Heavy Chain Variable Region [IGHV]) Based on Investigator Assessment - Kaplan Meier Landmark Estimates at Month 48 | PFS was analyzed within the high-risk population of participants with del17p or TP53 mutation or del 11q or IGHV unmutated at baseline per central lab results. PFS was defined as time from the date randomization to the date of first investigator-confirmed PD or date of death due to any cause, whichever occurred first, regardless of the use of subsequent antineoplastic therapy prior to documented PD or death. Assessment of PD was conducted in accordance with the IWCLL 2008 criteria (Halleck et al) with the modification that treatment-related lymphocytosis in the absence of other signs or symptoms of PD was not considered progressive disease. As the median PFS was not reached in the experimental (IBR+OB) arm at the time of the analysis, Kaplan Meier landmark estimates of the PFS rate at 48 months (that is, the estimated percentage of participants with progression-free survival at Month 48) are presented. | Month 48 (Median follow-up time was 44.6 months at the time of the final analysis [data cutoff date: 17 October 2019]). |
| Final Analysis: Rate of Sustained Hemoglobin Improvement | Percentage of participants with sustained hemoglobin improvement, defined as hemoglobin increase ≥ 2 g/dL over baseline continuously for ≥ 56 days without blood transfusions or growth factors. | Median follow-up time was 44.6 months at the time of the final analysis (data cutoff date: 17 October 2019). |
| Final Analysis: Rate of Minimal Residual Disease (MRD)-Negative Response | Percentage of participants who achieved MRD-negative response, defined as < 1 CLL cell per 10,000 leukocytes as assessed by flow cytometry of a bone marrow aspirate per central laboratory. MRD samples were collected before initiation of subsequent antineoplastic treatment and MRD status was reported by central lab within 5 days after collection date. Participants with missing MRD data were considered non-responders. | Median follow-up time was 44.6 months at the time of the final analysis (data cutoff date: 17 October 2019). |
| Final Analysis: ORR Based on Investigator Assessment | ORR, defined as the percentage of participants achieving a best overall response of protocol-specified CR, CRi, nPR or PR per investigator assessment at or prior to initiation of subsequent antineoplastic therapy. Assessment of response included physical examination, radiographic imaging, and evaluation of blood and marrow (if applicable), evaluated in accordance with the IWCLL 2008 criteria (Halleck et al). CR, CRi, nPR, and PR required confirmation with 2 consecutive assessments that were at least 56 days apart and no use of blood supportive product and/or growth factor during this period. Kaplan-Meier estimate. | Median follow-up time was 44.6 months at the time of the final analysis (data cutoff date: 17 October 2019). |
| Final Analysis: Overall Survival (OS) - Kaplan Meier Landmark Estimates at Month 48 | OS, defined as the time from the date of randomization to the date of death from any cause. All deaths observed as the time of the analysis were considered as events. For participants who were not known to have died at the time of the analysis, OS data were censored at the date last known alive. As the median OS was not reached in either treatment arm at the time of the analysis, Kaplan Meier point estimates of the OS rate (that is, the estimated percentage of participants still surviving at Month 48 [final analysis]) are presented. | Month 48 (Median follow-up time was 44.6 months at the time of the final analysis [data cutoff date: 17 October 2019]). |
| Final Analysis: Rate of Sustained Platelet Improvement | Percentage of participants with platelet counts increase ≥ 50% over baseline continuously for ≥ 56 days without blood transfusion or growth factors. | Median follow-up time was 44.6 months at the time of the final analysis (data cutoff date: 17 October 2019). |
| Fort Myers |
| Florida |
| United States |
| Site Reference ID/Investigator# 0763 | West Palm Beach | Florida | United States |
| Site Reference ID/Investigator# 071 | Louisville | Kentucky | United States |
| Site Reference ID/Investigator# 0712 | Las Vegas | Nevada | United States |
| Site Reference ID/Investigator# 0845 | Cincinnati | Ohio | United States |
| Site Reference ID/Investigator# 0868 | Chattanooga | Tennessee | United States |
| Site Reference ID/Investigator# 0123 | Nashville | Tennessee | United States |
| Site Reference ID/Investigator #0503 | Woolloongabba | Queensland | Australia |
| Site Reference ID/Investigator# 0650 | Adelaide | South Australia | Australia |
| Site Reference ID/Investigator# 0888 | Ballarat | Victoria | Australia |
| Site Reference ID/Investigator# 0193 | Box Hill | Victoria | Australia |
| Site Reference ID/Investigator# 0633 | Fitzroy | Victoria | Australia |
| Site Reference ID/Investigator# 0170 | Heidelberg | Victoria | Australia |
| Site Reference ID/Investigator# 0352 | Linz | Austria |
| Site Reference ID/Investigator# 0869 | Salzburg | Austria |
| Site Reference ID/Investigator# 0559 | Leuven | Belgium |
| Site Reference ID/Investigator# 0850 | Turnhout | Belgium |
| Site Reference ID/Investigator# 018 | Edmonton | Alberta | Canada |
| Site Reference ID/Investigator# 0564 | Hradec Králové | Czechia |
| Site Reference ID/Investigator# 0854 | Prague | Czechia |
| Site Reference ID/Investigator# 0769 | Pessac | Gironde | France |
| Site Reference ID/Investigator# 0520 | Nantes | Loire Atlantique | France |
| Site Reference ID/Investigator# 0775 | Vandœuvre-lès-Nancy | Meurthe Et Moselle | France |
| Site Reference ID/Investigator# 0855 | Bayonne | Pyrenees Atlantiques | France |
| Site Reference ID/Investigator# 0573 | Haifa | Israel |
| Site Reference ID/Investigator# 0577 | Jerusalem | Israel |
| Site Reference ID/Investigator# 0579 | Jerusalem | Israel |
| Site Reference ID/Investigator# 0575 | Petah Tikva | Israel |
| Site Reference ID/Investigator# 0856 | Tel Aviv | Israel |
| Site Reference ID/Investigator# 0875 | Ẕerifin | Israel |
| Site Reference ID/Investigator# 0860 | Florence | Italy |
| Site Reference ID/Investigator# 0523 | Milan | Italy |
| Site Reference ID/Investigator# 0581 | Milan | Italy |
| Site Reference ID/Investigator# 0584 | Milan | Italy |
| Site Reference ID/Investigator# 0524 | Modena | Italy |
| Site Reference ID/Investigator# 0582 | Novara | Italy |
| Site Reference ID/Investigator# 0732 | Roma | Italy |
| Site Reference ID/Investigator# 0859 | Siena | Italy |
| Site Reference ID/Investigator# 0663 | Auckland | New Zealand |
| Site Reference ID/Investigator# 662 | Auckland | New Zealand |
| Site Reference ID/Investigator# 0586 | Hamilton | New Zealand |
| Site Reference ID/Investigator# 0592 | Brzozów | Poland |
| Site Reference ID/Investigator# 0531 | Lodz | Poland |
| Site Reference ID/Investigator# 0708 | Nizhny Novgorod | Russia |
| Site Reference ID/Investigator# 0707 | Ryazan | Russia |
| Site Reference ID/Investigator# 0881 | Saint Petersburg | Russia |
| Site Reference ID/Investigator# 710 | Saint Petersburg | Russia |
| Site Reference ID/Investigator# 304 | Yaroslavl | Russia |
| Site Reference ID/Investigator# 0604 | L'Hospitalet de Llobregat | Madrid | Spain |
| Site Reference ID/Investigator# 0536 | Majadahonda | Madrid | Spain |
| Site Reference ID/Investigator# 0533 | Barcelona | Spain |
| Site Reference ID/Investigator# 0534 | Barcelona | Spain |
| Site Reference ID/Investigator# 0535 | Barcelona | Spain |
| Site Reference ID/Investigator# 0537 | Madrid | Spain |
| Site Reference ID/Investigator# 0864 | Madrid | Spain |
| Site Reference ID/Investigator# 0874 | Madrid | Spain |
| Site Reference ID/Investigator# 0790 | Salamanca | Spain |
| Site Reference ID/Investigator# 0870 | Borås | Sweden |
| Site Reference ID/Investigator# 0865 | Luleå | Sweden |
| Site Reference ID/Investigator# 0631 | Lund | Sweden |
| Site Reference ID/Investigator# 0632 | Stockholm | Sweden |
| Site Reference ID/Investigator# 0678 | Istanbul | Nisantasi | Turkey (Türkiye) |
| Site Reference ID/Investigator# 0608 | Ankara | Turkey (Türkiye) |
| Site Reference ID/Investigator# 606 | Ankara | Turkey (Türkiye) |
| Site Reference ID/Investigator# 0889 | Denizli | Turkey (Türkiye) |
| Site Reference ID/Investigator# 0601 | Izmir | Turkey (Türkiye) |
| Site Reference ID/Investigator# 0866 | Samsun | Turkey (Türkiye) |
| Site Reference ID/Investigator# 0867 | Harlow | Essex | United Kingdom |
| Site Reference ID/Investigator# 0365 | London | United Kingdom |
| Site Reference ID/Investigator# 0543 | London | United Kingdom |
| Derived |
| Abuhelwa AY, Almansour SA, Brown JR, Al-Shamsi HO, Abuhelwa Z, Kharaba Z, Bustanji Y, Semreen MH, Ali S, Alhuraiji A, McKinnon RA, Sorich MJ, Alzoubi KH, Hopkins AM. Statin use and survival in CLL/SLL treated with ibrutinib: pooled analysis of 4 randomized controlled trials. Blood Adv. 2025 Jul 22;9(14):3566-3575. doi: 10.1182/bloodadvances.2024015287. |
| 35021599 | Derived | Moreno C, Greil R, Demirkan F, Tedeschi A, Anz B, Larratt L, Simkovic M, Novak J, Strugov V, Gill D, Gribben JG, Kwei K, Dai S, Hsu E, Dean JP, Flinn IW. First-line treatment of chronic lymphocytic leukemia with ibrutinib plus obinutuzumab versus chlorambucil plus obinutuzumab: final analysis of the randomized, phase III iLLUMINATE trial. Haematologica. 2022 Sep 1;107(9):2108-2120. doi: 10.3324/haematol.2021.279012. |
| 35014928 | Derived | Burger JA, Robak T, Demirkan F, Bairey O, Moreno C, Simpson D, Munir T, Stevens DA, Dai S, Cheung LWK, Kwei K, Lal I, Hsu E, Kipps TJ, Tedeschi A. Up to 6.5 years (median 4 years) of follow-up of first-line ibrutinib in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma and high-risk genomic features: integrated analysis of two phase 3 studies. Leuk Lymphoma. 2022 Jun;63(6):1375-1386. doi: 10.1080/10428194.2021.2020779. Epub 2022 Jan 11. |
| 34865212 | Derived | Allan JN, Shanafelt T, Wiestner A, Moreno C, O'Brien SM, Li J, Krigsfeld G, Dean JP, Ahn IE. Long-term efficacy of first-line ibrutinib treatment for chronic lymphocytic leukaemia in patients with TP53 aberrations: a pooled analysis from four clinical trials. Br J Haematol. 2022 Feb;196(4):947-953. doi: 10.1111/bjh.17984. Epub 2021 Dec 5. |
| 34018029 | Derived | Greil R, Tedeschi A, Moreno C, Anz B, Larratt L, Simkovic M, Gill D, Gribben JG, Flinn IW, Wang Z, Cheung LWK, Nguyen AN, Zhou C, Styles L, Demirkan F. Pretreatment with ibrutinib reduces cytokine secretion and limits the risk of obinutuzumab-induced infusion-related reactions in patients with CLL: analysis from the iLLUMINATE study. Ann Hematol. 2021 Jul;100(7):1733-1742. doi: 10.1007/s00277-021-04536-6. Epub 2021 May 20. |
| FG001 |
| CLB+OB |
Chlorambucil (CLB) given orally at a dose of 0.5 mg/kg body weight up to a total of 6 cycles on Days 1 and 15 of each cycle or until disease progression or unacceptable toxicity. Intravenous obinutuzumab (OB) given on Days 1 and 2 (100 mg on Day 1 and 900 mg on Day 2), 1000 mg on Days 8 and 15 of Cycle 1 and 1000 mg on Day 1 of each cycle up to 6 cycles or until disease progression or unacceptable toxicity. |
| COMPLETED | On-study until study termination by sponsor. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | IBR+OB | Ibrutinib (IBR) given orally at a dose of 420 mg/day until progressive disease or unacceptable toxicity. Intravenous obinutuzumab (OB) given on Days 1 and 2 (100 mg on Day 1 and 900 mg on Day 2), 1000 mg on Days 8 and 15 of Cycle 1 and 1000 mg on Day 1 of each cycle up to 6 cycles or until progressive disease or unacceptable toxicity. |
| BG001 | CLB+OB | Chlorambucil (CLB) given orally at a dose of 0.5 mg/kg body weight up to a total of 6 cycles on Days 1 and 15 of each cycle or until disease progression or unacceptable toxicity. Intravenous obinutuzumab (OB) given on Days 1 and 2 (100 mg on Day 1 and 900 mg on Day 2), 1000 mg on Days 8 and 15 of Cycle 1 and 1000 mg on Day 1 of each cycle up to 6 cycles or until disease progression or unacceptable toxicity. |
| BG002 | 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, Categorical | Count of Participants | Participants |
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| Age, Continuous | Median | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Primary Analysis: Progression Free Survival (PFS) Based on Independent Review Committee (IRC) Assessment - Kaplan Meier Landmark Estimates at Month 30 | PFS was defined as time from the date randomization to the date of first IRC-confirmed disease progression (PD) or date of death due to any cause, whichever occurred first, regardless of the use of subsequent antineoplastic therapy prior to documented PD or death. Assessment of PD was conducted in accordance with the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 criteria (Halleck et al) with the modification that treatment-related lymphocytosis in the absence of other signs or symptoms of disease progression was not considered progressive disease. The primary analysis was performed after observing 94 PFS events as pre-specified in the study protocol. As the median PFS was not reached in the experimental (IBR+OB) arm at the time of the analysis, Kaplan Meier landmark estimates of the PFS rate at 30 months (that is, the estimated percentage of participants with progression-free survival at Month 30) are presented. | Intent to Treat population: all randomized participants | Posted | Number | 95% Confidence Interval | percentage of participants | Month 30 (Median follow-up time was 31.3 months at the time of the primary analysis [data cutoff date: 26 March 2018]). |
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| Secondary | Primary Analysis: PFS in High-Risk Sub-Population (del17p/TP53 Mutation/Del 11q) Based on IRC Assessment - Kaplan Meier Landmark Estimates at Month 30 | PFS was analyzed within the high-risk sub-population of participants with del17p or TP53 mutation or del 11q at baseline per central lab results. PFS was defined as time from the date randomization to the date of first IRC-confirmed PD or date of death due to any cause, whichever occurred first, regardless of the use of subsequent antineoplastic therapy prior to documented PD or death. Assessment of PD was conducted in accordance with the IWCLL 2008 criteria (Halleck et al) with the modification that treatment-related lymphocytosis in the absence of other signs or symptoms of PD was not considered progressive disease. As the median PFS was not reached in the experimental (IBR+OB) arm at the time of the analysis, Kaplan Meier landmark estimates of the PFS rate at 30 months (that is, the estimated percentage of participants with progression-free survival at Month 30) are presented. | High-Risk Sub-Population Analysis Set: participants with del17p or TP53 mutation or del 11q at baseline per central lab results. | Posted | Number | 95% Confidence Interval | percentage of participants | Month 30 (Median follow-up time was 31.3 months at the time of the primary analysis [data cutoff date: 26 March 2018]). |
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| Secondary | Primary Analysis: Rate of Sustained Hemoglobin Improvement | Percentage of participants with sustained hemoglobin improvement, defined as hemoglobin increase ≥ 2 g/dL over baseline continuously for ≥ 56 days without blood transfusions or growth factors. | Intent to Treat population: all randomized participants | Posted | Number | percentage of participants | Median follow-up time was 31.3 months at the time of the primary analysis (data cutoff date: 26 March 2018). |
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| Secondary | Primary Analysis: Rate of Minimal Residual Disease (MRD)-Negative Response | Percentage of participants who achieved MRD-negative response, defined as < 1 CLL cell per 10,000 leukocytes as assessed by flow cytometry of a bone marrow aspirate per central laboratory. MRD samples were collected before initiation of subsequent antineoplastic treatment and MRD status was reported by central lab within 5 days after collection date. Participants with missing MRD data were considered non-responders. | Intent to Treat population: all randomized participants | Posted | Number | percentage of participants | Median follow-up time was 31.3 months at the time of the primary analysis (data cutoff date: 26 March 2018). |
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| Secondary | Primary Analysis: Overall Response Rate (ORR) Based on IRC Assessment | ORR, defined as the percentage of participants achieving a best overall response of protocol-specified complete response (CR), CR with incomplete blood count recovery (CRi), nodular partial response (nPR), or partial response (PR) per IRC assessment at or prior to initiation of subsequent antineoplastic therapy. Assessment of response included physical examination, radiographic imaging, and evaluation of blood and marrow (if applicable), evaluated in accordance with the IWCLL 2008 criteria (Halleck et al). CR, CRi, nPR, and PR required confirmation with 2 consecutive assessments that were at least 56 days apart and no use of blood supportive product and/or growth factor during this period. Kaplan-Meier estimate. | Intent to Treat population: all randomized participants | Posted | Number | percentage of participants | Median follow-up time was 31.3 months at the time of the primary analysis (data cutoff date: 26 March 2018). |
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| Secondary | Primary Analysis: Overall Survival (OS) - Kaplan Meier Landmark Estimates at Month 30 | OS, defined as the time from the date of randomization to the date of death from any cause. All deaths observed as the time of the analysis were considered as events. For participants who were not known to have died at the time of the analysis, OS data were censored at the date last known alive. As the median OS was not reached in either treatment arm at the time of the analysis, Kaplan Meier landmark estimates of the OS rate (that is, the estimated percentage of participants still surviving at Month 30 [primary analysis]) are presented. | Intent to Treat population: all randomized participants | Posted | Number | 95% Confidence Interval | percentage of participants | Month 30 (Median follow-up time was 31.3 months at the time of the primary analysis [data cutoff date: 26 March 2018]). |
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| Secondary | Primary Analysis: Rate of Grade ≥ 3 or Serious Infusion-Related Reaction (IRR) Adverse Events | Percentage of participants experiencing grade ≥ 3 (severe or life threatening) or serious IRR adverse events that started on the day of an obinutuzumab infusion and were assessed as related or possibly related to obinutuzumab. Categories included those events with the Medical Dictionary for Regulatory Activities (MedDRA) dictionary preferred term of IRR and those events which are among the customized standardized MedDRA query (SMQ) for IRR. | Intent to Treat population: all randomized participants | Posted | Number | percentage of participants | Median follow-up time was 31.3 months at the time of the primary analysis (data cutoff date: 26 March 2018). |
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| Secondary | Primary Analysis: Rate of Sustained Platelet Improvement | Percentage of participants with platelet counts increase ≥ 50% over baseline continuously for ≥ 56 days without blood transfusion or growth factors. | Intent to Treat population: all randomized participants | Posted | Number | percentage of participants | Median follow-up time was 31.3 months at the time of the primary analysis (data cutoff date: 26 March 2018). |
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| Secondary | Primary Analysis: Rate of Clinically Meaningful Improvement in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire EuroQol Five-Dimension (EQ-5D-5L) | Percentage of participants with EQ-5D-5L utility score increase ≥ 0.08 points over baseline at or prior to initiation of subsequent antineoplastic therapy. The EQ-5D-5L is a standardized non-disease specific instrument for describing and valuing health-related quality of life, comprising 5 dimensions of health (mobility, self -care, usual activities, pain/discomfort, and anxiety/depression) to describe the participant's current health state. Each dimension comprises 5 levels with corresponding numeric scores, where 1 indicates no problems, and 5 indicates extreme problems. A unique EQ-5D-5L health state is defined by combining the numeric level scores for each of the 5 dimensions and the total score is normalized from -0.594 to 1.000, with higher scores representing a better health state. An increase in the EQ-5D-5L total score indicates improvement. Participants with missing EQ-5D-5L data were considered not achieving clinically meaningful improvement. | Intent to Treat population: all randomized participants with a baseline and post-baseline assessment. | Posted | Number | percentage of participants | Median follow-up time was 31.3 months at the time of the primary analysis (data cutoff date: 26 March 2018). |
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| Secondary | Final Analysis: PFS in High-Risk Population (del17p/TP53 Mutation/Del 11q/Unmutated Immunoglobulin Heavy Chain Variable Region [IGHV]) Based on Investigator Assessment - Kaplan Meier Landmark Estimates at Month 48 | PFS was analyzed within the high-risk population of participants with del17p or TP53 mutation or del 11q or IGHV unmutated at baseline per central lab results. PFS was defined as time from the date randomization to the date of first investigator-confirmed PD or date of death due to any cause, whichever occurred first, regardless of the use of subsequent antineoplastic therapy prior to documented PD or death. Assessment of PD was conducted in accordance with the IWCLL 2008 criteria (Halleck et al) with the modification that treatment-related lymphocytosis in the absence of other signs or symptoms of PD was not considered progressive disease. As the median PFS was not reached in the experimental (IBR+OB) arm at the time of the analysis, Kaplan Meier landmark estimates of the PFS rate at 48 months (that is, the estimated percentage of participants with progression-free survival at Month 48) are presented. | High-Risk Population Analysis Set: participants with del17p or TP53 mutation or del 11q or IGHV unmutated at baseline per central lab results. | Posted | Number | 95% Confidence Interval | percentage of participants | Month 48 (Median follow-up time was 44.6 months at the time of the final analysis [data cutoff date: 17 October 2019]). |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Final Analysis: Rate of Sustained Hemoglobin Improvement | Percentage of participants with sustained hemoglobin improvement, defined as hemoglobin increase ≥ 2 g/dL over baseline continuously for ≥ 56 days without blood transfusions or growth factors. | Intent to Treat population: all randomized participants | Posted | Number | percentage of participants | Median follow-up time was 44.6 months at the time of the final analysis (data cutoff date: 17 October 2019). |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Final Analysis: Rate of Minimal Residual Disease (MRD)-Negative Response | Percentage of participants who achieved MRD-negative response, defined as < 1 CLL cell per 10,000 leukocytes as assessed by flow cytometry of a bone marrow aspirate per central laboratory. MRD samples were collected before initiation of subsequent antineoplastic treatment and MRD status was reported by central lab within 5 days after collection date. Participants with missing MRD data were considered non-responders. | Intent to Treat population: all randomized participants | Posted | Number | percentage of participants | Median follow-up time was 44.6 months at the time of the final analysis (data cutoff date: 17 October 2019). |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Final Analysis: ORR Based on Investigator Assessment | ORR, defined as the percentage of participants achieving a best overall response of protocol-specified CR, CRi, nPR or PR per investigator assessment at or prior to initiation of subsequent antineoplastic therapy. Assessment of response included physical examination, radiographic imaging, and evaluation of blood and marrow (if applicable), evaluated in accordance with the IWCLL 2008 criteria (Halleck et al). CR, CRi, nPR, and PR required confirmation with 2 consecutive assessments that were at least 56 days apart and no use of blood supportive product and/or growth factor during this period. Kaplan-Meier estimate. | Intent to Treat population: all randomized participants | Posted | Number | percentage of participants | Median follow-up time was 44.6 months at the time of the final analysis (data cutoff date: 17 October 2019). |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Final Analysis: Overall Survival (OS) - Kaplan Meier Landmark Estimates at Month 48 | OS, defined as the time from the date of randomization to the date of death from any cause. All deaths observed as the time of the analysis were considered as events. For participants who were not known to have died at the time of the analysis, OS data were censored at the date last known alive. As the median OS was not reached in either treatment arm at the time of the analysis, Kaplan Meier point estimates of the OS rate (that is, the estimated percentage of participants still surviving at Month 48 [final analysis]) are presented. | Intent to Treat population: all randomized participants | Posted | Number | 95% Confidence Interval | percentage of participants | Month 48 (Median follow-up time was 44.6 months at the time of the final analysis [data cutoff date: 17 October 2019]). |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Final Analysis: Rate of Sustained Platelet Improvement | Percentage of participants with platelet counts increase ≥ 50% over baseline continuously for ≥ 56 days without blood transfusion or growth factors. | Intent to Treat population: all randomized participants | Posted | Number | percentage of participants | Median follow-up time was 44.6 months at the time of the final analysis (data cutoff date: 17 October 2019). |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Final Analysis: PFS Based on Investigator Assessment - Kaplan Meier Landmark Estimates at Month 48 | PFS was defined as time from the date randomization to the date of first investigator-confirmed PD or date of death due to any cause, whichever occurred first, regardless of the use of subsequent antineoplastic therapy prior to documented PD or death. Assessment of PD was conducted in accordance with the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 criteria (Halleck et al) with the modification that treatment-related lymphocytosis in the absence of other signs or symptoms of disease progression was not considered progressive disease. As the median PFS was not reached in the experimental (IBR+OB) arm at the time of the analysis, Kaplan Meier landmark estimates of the PFS rate at 48 months (that is, the estimated percentage of participants with progression-free survival at Month 48) are presented. | Intent to Treat population: all randomized participants | Posted | Number | 95% Confidence Interval | percentage of participants | Month 48 (Median follow-up time was 44.6 months at the time of the final analysis [data cutoff date: 17 October 2019]). |
|
From first dose of study drug up to 30 days after the last dose of study drug. Median treatment duration for the IBR+OB arm was 42.3 (IBR) and 4.6 (OB) months. Median treatment duration for the CLB+OB arm was 5.1 (CLB) and 4.6 (OB) months. Final analysis data (data cutoff date: 17 October 2019).
One participant in the CLB+OB arm was randomized but went off study without any treatment. This participant had received baseline assessments and was included in all efficacy analyses but was excluded from safety population, i.e. not at risk for adverse event assessment.
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 | IBR+OB | Ibrutinib (IBR) given orally at a dose of 420 mg/day until progressive disease or unacceptable toxicity. Intravenous obinutuzumab (OB) given on Days 1 and 2 (100 mg on Day 1 and 900 mg on Day 2), 1000 mg on Days 8 and 15 of Cycle 1 and 1000 mg on Day 1 of each cycle up to 6 cycles or until progressive disease or unacceptable toxicity. | 22 | 113 | 69 | 113 | 112 | 113 |
| EG001 | CLB+OB | Chlorambucil (CLB) given orally at a dose of 0.5 mg/kg body weight up to a total of 6 cycles on Days 1 and 15 of each cycle or until disease progression or unacceptable toxicity. Intravenous obinutuzumab (OB) given on Days 1 and 2 (100 mg on Day 1 and 900 mg on Day 2), 1000 mg on Days 8 and 15 of Cycle 1 and 1000 mg on Day 1 of each cycle up to 6 cycles or until disease progression or unacceptable toxicity. | 21 | 115 | 41 | 115 | 111 | 115 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Aplastic anaemia | Blood and lymphatic system disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Atrial tachycardia | Cardiac disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Pericarditis constrictive | Cardiac disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Stress cardiomyopathy | Cardiac disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Goitre | Endocrine disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Retinal detachment | Eye disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Impaired gastric emptying | Gastrointestinal disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Large intestine polyp | Gastrointestinal disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Oesophageal rupture | Gastrointestinal disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Proctitis | Gastrointestinal disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Catheter site haematoma | General disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Death | General disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Multi-organ disorder | General disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Sudden Death | General disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Abscess | Infections and infestations | MedDRA Version 22.0 | Systematic Assessment |
| |
| Bacterial sepsis | Infections and infestations | MedDRA Version 22.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA Version 22.0 | Systematic Assessment |
| |
| Bronchopulmonary aspergillosis | Infections and infestations | MedDRA Version 22.0 | Systematic Assessment |
| |
| Bursitis infective staphylococcal | Infections and infestations | MedDRA Version 22.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA Version 22.0 | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA Version 22.0 | Systematic Assessment |
| |
| Escherichia sepsis | Infections and infestations | MedDRA Version 22.0 | Systematic Assessment |
| |
| Escherichia urinary tract infection | Infections and infestations | MedDRA Version 22.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA Version 22.0 | Systematic Assessment |
| |
| Herpes Zoster | Infections and infestations | MedDRA Version 22.0 | Systematic Assessment |
| |
| Infective aneurysm | Infections and infestations | MedDRA Version 22.0 | Systematic Assessment |
| |
| Listeria sepsis | Infections and infestations | MedDRA Version 22.0 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA Version 22.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA Version 22.0 | Systematic Assessment |
| |
| Pneumocystis jirovecii pneumonia | Infections and infestations | MedDRA Version 22.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 22.0 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA Version 22.0 | Systematic Assessment |
| |
| Pneumonia klebsiella | Infections and infestations | MedDRA Version 22.0 | Systematic Assessment |
| |
| Prostate infection | Infections and infestations | MedDRA Version 22.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA Version 22.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA Version 22.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA Version 22.0 | Systematic Assessment |
| |
| Sinusitis fungal | Infections and infestations | MedDRA Version 22.0 | Systematic Assessment |
| |
| Soft tissue infection | Infections and infestations | MedDRA Version 22.0 | Systematic Assessment |
| |
| Streptococcal bacteraemia | Infections and infestations | MedDRA Version 22.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA Version 22.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA Version 22.0 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA Version 22.0 | Systematic Assessment |
| |
| Vascular device infection | Infections and infestations | MedDRA Version 22.0 | Systematic Assessment |
| |
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA Version 22.0 | Systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDRA Version 22.0 | Systematic Assessment |
| |
| Craniocerebral injury | Injury, poisoning and procedural complications | MedDRA Version 22.0 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA Version 22.0 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA Version 22.0 | Systematic Assessment |
| |
| Incisional hernia | Injury, poisoning and procedural complications | MedDRA Version 22.0 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA Version 22.0 | Systematic Assessment |
| |
| Jaw fracture | Injury, poisoning and procedural complications | MedDRA Version 22.0 | Systematic Assessment |
| |
| Pubis fracture | Injury, poisoning and procedural complications | MedDRA Version 22.0 | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA Version 22.0 | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA Version 22.0 | Systematic Assessment |
| |
| Thoracic vertebral fracture | Injury, poisoning and procedural complications | MedDRA Version 22.0 | Systematic Assessment |
| |
| Traumatic haematoma | Injury, poisoning and procedural complications | MedDRA Version 22.0 | Systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA Version 22.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Tumour lysis syndrome | Metabolism and nutrition disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Compartment syndrome | Musculoskeletal and connective tissue disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Inclusion body myositis | Musculoskeletal and connective tissue disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Osteolysis | Musculoskeletal and connective tissue disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Osteonecrosis of jaw | Musculoskeletal and connective tissue disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Adenocarcinoma gastric | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 22.0 | Systematic Assessment |
| |
| Adenocarcinoma of colon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 22.0 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 22.0 | Systematic Assessment |
| |
| Benign renal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 22.0 | Systematic Assessment |
| |
| Chronic lymphocytic leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 22.0 | Systematic Assessment |
| |
| Colorectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 22.0 | Systematic Assessment |
| |
| Colorectal cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 22.0 | Systematic Assessment |
| |
| Essential thrombocythaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 22.0 | Systematic Assessment |
| |
| Invasive ductal breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 22.0 | Systematic Assessment |
| |
| Kaposi's sarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 22.0 | Systematic Assessment |
| |
| Keratoacanthoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 22.0 | Systematic Assessment |
| |
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 22.0 | Systematic Assessment |
| |
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 22.0 | Systematic Assessment |
| |
| Neuroendocrine carcinoma of the skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 22.0 | Systematic Assessment |
| |
| Non-small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 22.0 | Systematic Assessment |
| |
| Osteoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 22.0 | Systematic Assessment |
| |
| Prostate Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 22.0 | Systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 22.0 | Systematic Assessment |
| |
| Cerebral ischaemia | Nervous system disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Depressed level of consciousness | Nervous system disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Acute psychosis | Psychiatric disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Complete Suicide | Psychiatric disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Uterine prolapse | Reproductive system and breast disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Bronchitis chronic | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Peripheral ischaemia | Vascular disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Venous thrombosis limb | Vascular disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Increased tendency to bruise | Blood and lymphatic system disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Spontaneous haematoma | Blood and lymphatic system disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA Version 22.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA Version 22.0 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA Version 22.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA Version 22.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA Version 22.0 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA Version 22.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 22.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA Version 22.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA Version 22.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA Version 22.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA Version 22.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA Version 22.0 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA Version 22.0 | Systematic Assessment |
| |
| Blood creatine increased | Investigations | MedDRA Version 22.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA Version 22.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Iron deficiency | Metabolism and nutrition disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Dry Skin | Skin and subcutaneous tissue disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Onychoclasis | Skin and subcutaneous tissue disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lori Styles | Pharmacyclics LLC, An AbbVie Company | (408) 215-3770 | lstyles@pcyc.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 28, 2018 | Mar 20, 2019 | SAP_001.pdf |
| 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 |
|---|---|
| C551803 | ibrutinib |
| C543332 | obinutuzumab |
| D002699 | Chlorambucil |
| ID | Term |
|---|---|
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Czechia |
|
| United Kingdom |
|
| Spain |
|
| Russia |
|
| New Zealand |
|
| Canada |
|
| Austria |
|
| Sweden |
|
| Turkey |
|
| Belgium |
|
| Poland |
|
| Italy |
|
| Israel |
|
| France |
|
| Australia |
|
| OG001 | CLB+OB | Chlorambucil (CLB) given orally at a dose of 0.5 mg/kg body weight up to a total of 6 cycles on Days 1 and 15 of each cycle or until disease progression or unacceptable toxicity. Intravenous obinutuzumab (OB) given on Days 1 and 2 (100 mg on Day 1 and 900 mg on Day 2), 1000 mg on Days 8 and 15 of Cycle 1 and 1000 mg on Day 1 of each cycle up to 6 cycles or until disease progression or unacceptable toxicity. |
|
|
|
| Units | Counts |
|---|
| Participants |
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|
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| Units |
|---|
| Counts |
|---|
| Participants |
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| OG001 | CLB+OB | Chlorambucil (CLB) given orally at a dose of 0.5 mg/kg body weight up to a total of 6 cycles on Days 1 and 15 of each cycle or until disease progression or unacceptable toxicity. Intravenous obinutuzumab (OB) given on Days 1 and 2 (100 mg on Day 1 and 900 mg on Day 2), 1000 mg on Days 8 and 15 of Cycle 1 and 1000 mg on Day 1 of each cycle up to 6 cycles or until disease progression or unacceptable toxicity. |
|
|
|
| OG001 | CLB+OB | Chlorambucil (CLB) given orally at a dose of 0.5 mg/kg body weight up to a total of 6 cycles on Days 1 and 15 of each cycle or until disease progression or unacceptable toxicity. Intravenous obinutuzumab (OB) given on Days 1 and 2 (100 mg on Day 1 and 900 mg on Day 2), 1000 mg on Days 8 and 15 of Cycle 1 and 1000 mg on Day 1 of each cycle up to 6 cycles or until disease progression or unacceptable toxicity. |
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| Units | Counts |
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| Participants |
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|
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| Units |
|---|
| Counts |
|---|
| Participants |
|
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|
Chlorambucil (CLB) given orally at a dose of 0.5 mg/kg body weight up to a total of 6 cycles on Days 1 and 15 of each cycle or until disease progression or unacceptable toxicity. Intravenous obinutuzumab (OB) given on Days 1 and 2 (100 mg on Day 1 and 900 mg on Day 2), 1000 mg on Days 8 and 15 of Cycle 1 and 1000 mg on Day 1 of each cycle up to 6 cycles or until disease progression or unacceptable toxicity. |
|
|
|