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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-001552-54 | EudraCT Number | ||
| CTR20220712 | Other Identifier | ChinaDrugTrials | |
| 2023-509975-17-00 | EU Trial (CTIS) Number |
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This clinical study examined the safety and efficacy of the combination of zanubrutinib and obinutuzumab versus obinutuzumab alone in adults with follicular lymphoma whose disease returned after or did not respond to prior therapy.
This study randomly assigned participants in a 2:1 ratio to receive either zanubrutinib plus obinutuzumab or obinutuzumab alone. The assignment considered how many prior treatments participants had received, whether their cancer had stopped responding to rituximab, and whether they were enrolled in Mainland China or other regions. Each treatment cycle lasted 28 days, with zanubrutinib taken by mouth twice daily and obinutuzumab given intravenously on a set schedule, followed by optional maintenance for up to 24 months. Participants who had obinutuzumab alone could have switched to the combination treatment if their disease worsened or did not respond after 12 months, if confirmed by an independent review.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Obinutuzumab | Experimental | Participants received obinutuzumab 1000 milligrams (mg) intravenously on Days 1, 8, and 15 of Cycle 1, Day 1 of Cycles 2 to 6; and then every 8 weeks for an additional 24 months or until disease progression. Each treatment cycle was 28 days. Participants who experienced progressive disease or did not respond to therapy within 12 months may have received crossover treatment with zanubrutinib + obinutuzumab at the investigator's discretion. |
|
| Zanubrutinib + Obinutuzumab | Experimental | Participants received zanubrutinib 160 mg twice a day orally with or without food and obinutuzumab 1000 mg intravenously on Days 1, 8, and 15 of Cycle 1, Day 1 of Cycles 2 to 6, and then every 8 weeks for an additional 24 months or until disease progression. Each treatment cycle was 28 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zanubrutinib | Drug | Oral administration as a capsule |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) by Independent Central Review (ICR) Assessment | ORR was defined as the percentage of participants who achieved a best overall response of complete response (CR) or partial response (PR) per the Lugano Classification for Non-Hodgkin's Lymphoma. | From first dose to primary analysis data cutoff (08OCT2021) start of a new anticancer therapy, or the crossover date, whichever came first. Median follow-up was 12.45 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) as Assessed by the Investigator | ORR was defined as the percentage of participants who achieved a best overall response of complete response (CR) or partial response (PR) per the Lugano Classification for Non-Hodgkin's Lymphoma. | From first dose to primary analysis data cutoff (08OCT2021) start of a new anticancer therapy, or the crossover date, whichever came first. Median follow-up was 12.45 months. |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol-defined inclusion and exclusion criteria may have applied.
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | BeiGene | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University Winship Cancer Institute | Atlanta | Georgia | 30322-1013 | United States | ||
| University of Illinois At Chicago |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Trotman J, Folwer N, Auer R, Flowers C, Reed W, Stern JC, Huang J, Zinzani PL. Phase 2 Obinutuzumab Zanubrutinib (BGB-3111) in Patients with Relapsed/Refractory Follicular Lymphoma (R/R FL). American Society of Clinical Oncology, 2018. | ||
| Background | Fowler N, Trotman J, Auer R, Flowers C, Reed W, Marimpietri C, Huang J, Zinzani PL.Randomized phase 2 zanubrutinib (BGB-3111) + obinutuzumab (obi) vs obi monotherapy in patients (pts) with relapsed/refractory follicular lymphoma (R/R FL). American Society of Clinical Oncology. 2019 | ||
| Background | Fowler NH, Trotman J, Auer R, Flowers CR, Reed WF, Ivanova E, Huang J, Zinzani PL.Randomized Phase 2 Zanubrutinib (BGB-3111) + Obinutuzumab vs Obinutuzumab Monotherapy in Patients with Relapsed/Refractory Follicular Lymphoma (R/R FL). American Society of Hematology. 2019 | ||
| Background | Trotman J, Zinzani PL, Song Y, et al. Health-Related Quality of Life (HRQoL) in Patients With Relapsed/Refractory Follicular Lymphoma (R/R FL) Treated With Zanubrutinib + Obinutuzumab Versus Obinutuzumab Monotherapy: The ROSEWOOD Trial. Poster presented at: 65th ASH Annual Meeting and Exposition; December, 2023; San Diego, CA. https://doi.org/10.1182/blood-2023-181195 | ||
| Result | Judith Trotman, Pier Luigi Zinzani, Krimo Bouabdallah, Shanmei Liao, Adam Greenbaum, Laura Dima, Laurent Dumartin; Comparative Efficacy of Zanubrutinib Plus Obinutuzumab Versus Last Prior Treatment in Relapsed/Refractory Follicular Lymphoma: Growth Modulation Index Analysis from ROSEWOOD Study. Blood 2024; 144 (Supplement 1): 3029. doi: https://doi.org/10.1182/blood-2024-198500 |
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BeiGene shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved.
BeiGene shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations.
Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeiGene review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.
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After enrollment, participants were randomized 2:1 to zanubrutinib plus obinutuzumab or obinutuzumab alone, stratified by prior therapy, rituximab-refractory status, and region. Treatment began within 5 days, in 28-day cycles. At investigator discretion, those on obinutuzumab monotherapy could cross over to zanubrutinib plus obinutuzumab if progressive disease or non-response was confirmed by independent central review.
Participants were enrolled in multiple study centers in Australia, Europe, Asia, and North America.
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| ID | Title | Description |
|---|---|---|
| FG000 | Obinutuzumab | Obinutuzumab 1000 milligrams (mg) intravenously on Days 1, 8, and 15 of Cycle 1, Day 1 of Cycles 2 to 6; and then every 8 weeks for an additional 24 months or until disease progression. Each treatment cycle was 28 days. Participants who experienced progressive disease or did not respond to therapy within 12 months may have received crossover treatment with zanubrutinib plus obinutuzumab at the investigator's discretion. |
| 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 | Oct 10, 2023 | Dec 12, 2025 |
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| Obinutuzumab | Drug | Intravenous administration |
|
|
| Duration of Response (DOR) as Determined by Investigator Assessment | DOR was defined as the time from the date that a confirmed response (CR or PR) was first observed to the date of first documented disease progression or death, whichever occurred first. For participants in the monotherapy arm who crossed over to combination therapy, disease assessments after crossover were not included in the DOR calculation. Median DOR was estimated using the Kaplan-Meier method. | From first dose to primary analysis data cutoff (08OCT2021) start of a new anticancer therapy, or the crossover date, whichever came first. Median follow-up was 12.45 months. |
| DOR as Determined by ICR | DOR was defined as the time from the date that a confirmed response (CR or PR) was first observed to the date of first documented disease progression or death, whichever occurred first. For participants in the monotherapy arm who crossed over to combination therapy, disease assessments after crossover were not included in the DOR calculation. Median DOR was estimated using the Kaplan-Meier method. | From first dose to primary analysis data cutoff (08OCT2021) start of a new anticancer therapy, or the crossover date, whichever came first. Median follow-up was 12.45 months. |
| Progression-free Survival (PFS) | PFS was defined as the time from randomization to the date of first documented disease progression or death from any cause, whichever occurred first, as determined by the ICR or investigator assessment. For participants in the monotherapy arm who crossed over to combination therapy, disease assessments after crossover were not included in the PFS calculation. Median PFS was estimated using the Kaplan-Meier method. | From first dose to primary analysis data cutoff (08OCT2021) start of a new anticancer therapy, or the crossover date, whichever came first. Median follow-up was 12.45 months. |
| Overall Survival (OS) | OS was defined as the time from randomization to the date of death from any cause. Median OS was estimated using the Kaplan-Meier method. | From first dose to primary analysis data cutoff (08OCT2021) start of a new anticancer therapy, or the crossover date, whichever came first. Median follow-up was 12.45 months. |
| Complete Response Rate | CRR was defined as the percentage of participants who achieved a complete response or complete metabolic response as their best overall response, as determined by ICR and investigator assessment. Responses were assessed from randomization until the data cutoff date, the start of a new anticancer therapy, or the crossover date for participants in the monotherapy arm who switched to combination therapy. | From first dose to primary analysis data cutoff (08OCT2021) start of a new anticancer therapy, or the crossover date, whichever came first. Median follow-up was 12.45 months. |
| Time to Response (TTR) | TRR was defined as the time from randomization to the first date that response criteria (CR or PR) were met, as determined by ICR and investigator assessment. Only participants who achieved an overall response were included in the analysis. For participants in the monotherapy arm who crossed over to combination therapy, disease assessments after crossover were not included in the TRR calculation. | From first dose to primary analysis data cutoff (08OCT2021) start of a new anticancer therapy, or the crossover date, whichever came first. Median follow-up was 12.45 months. |
| Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status (GHS)/Quality of Life (QOL), Physical Functioning, Role Functioning, and Symptom Scores | The EORTC QLQ-C30 includes 30 questions covering 5 functional scales (physical, role, emotional, cognitive, social), 1 global health scale, 3 symptom scales (fatigue, nausea/vomiting, pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). Participants report their health over the past week. Most items use a 4-point scale (1 = Not at all to 4 = Very much), while 2 global QOL items use a 7-point scale (1 = Very poor to 7 = Excellent). Raw scores are linearly transformed to a 0-100 scale; higher GHS and functional scores and lower symptom scores indicate better quality of life. | Baseline, Week 12, and Week 24 |
| Change From Baseline in European Quality of Life 5-Dimensions, 5-level (EQ-5D-5L) Visual Analogue Scale (VAS) | The EQ-5D-5L measures health outcomes using a VAS to record a participant's self-rated health on a scale from 0 to 100, where 100 is 'the best health you can imagine' and 0 is 'the worst health you can imagine.' A higher score indicates better health outcomes. | Baseline, Week 12, and Week 24 |
| Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | An adverse event refers to any unintended or unfavorable sign, symptom, or condition (including abnormal lab results) that occurs during the study, regardless of whether it is linked to the study drug. | From first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy. |
| Area Under the Curve (AUCss) of Zanubrutinib at Steady State | Pharmacokinetic exposure parameters were estimated for each participant using a population pharmacokinetic (PK) model. | Cycle 1 Day 1 and Cycle 2 Day 1: Predose (within 30 minutes before zanubrutinib dosing) and 2 hours (± 30 minutes) post-dose. |
| Zanubrutinib Plasma Concentrations | Cycle 1 Day 1 and Cycle 2 Day 1: Predose (within 30 minutes before zanubrutinib dosing) and 2 hours (± 30 minutes) post-dose. |
| Minimum Observed Concentration (Cmin) of Zanubrutinib at Steady State | Pharmacokinetic exposure parameters were estimated for each participant using a population pharmacokinetic (PK) model. | Cycle 1 Day 1 and Cycle 2 Day 1: Predose (within 30 minutes before zanubrutinib dosing) and 2 hours (± 30 minutes) post-dose. |
| Maximum Observed Concentration (Cmax) of Zanubrutinib at Steady State | Cycle 1 Day 1 (2 hours postdose) and Cycle 2 Day 1 (predose and 2 hours postdose) |
| Chicago |
| Illinois |
| 60612-4795 |
| United States |
| Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | 89169-3321 | United States |
| Duke University | Durham | North Carolina | 27710 | United States |
| Canberra Hospital | Garran | Australian Capital Territory | ACT 2605 | Australia |
| Concord Repatriation General Hospital | Concord | New South Wales | NSW 2139 | Australia |
| Saint Vincents Hospital Sydney | Darlinghurst | New South Wales | NSW 2010 | Australia |
| Calvary Mater Newcastle | Waratah | New South Wales | NSW 2298 | Australia |
| Westmead Hospital | Westmead | New South Wales | NSW 2145 | Australia |
| Icon Cancer Centre Wesley | Auchenflower | Queensland | QLD 4066 | Australia |
| Icon Cancer Foundation | South Brisbane | Queensland | QLD 4101 | Australia |
| Royal Adelaide Hospital | Adelaide | South Australia | SA 5000 | Australia |
| Monash Health | Clayton | Victoria | VIC 3168 | Australia |
| St Vincents Hospital Melbourne | Fitzroy | Victoria | VIC 3065 | Australia |
| Peninsula Private Hospital | Frankston | Victoria | VIC 3199 | Australia |
| Royal Perth Hospital | Perth | Western Australia | WA 6000 | Australia |
| Minsk City Clinical Oncological Dispensary | Minsk | 220013 | Belarus |
| Nn Alexandrov National Cancer Centre of Belarus | Minsk | 223040 | Belarus |
| Vitebsk Regional Clinical Oncology Dispensary | Vitebsk | 210603 | Belarus |
| University Multiprofile Hospital For Active Treatment Dr Georgi Stranski | Pleven | 5803 | Bulgaria |
| Acibadem City Clinic Mhat Tokuda Ead | Sofia | 1407 | Bulgaria |
| University Multiprofile Hospital For Active Treatment Saint Ivan Rilski | Sofia | 1407 | Bulgaria |
| University Multiprofile Hospital For Active Treatment Alexandrovska | Sofia | 1431 | Bulgaria |
| The Ottawa Hospital | Ottawa | Ontario | K1H 8L6 | Canada |
| Jewish General Hospital | Montreal | Quebec | QC H3t 1E2 | Canada |
| Peking University Third Hospital | Beijing | Beijing Municipality | 100000 | China |
| Peking University Peoples Hospital | Beijing | Beijing Municipality | 100044 | China |
| Beijing Cancer Hospital | Beijing | Beijing Municipality | 100142 | China |
| Guangdong Provincial Peoples Hospital | Guangzhou | Guangdong | 510080 | China |
| Harbin Medical University Cancer Hospital | Harbin | Heilongjiang | 150000 | China |
| Henan Cancer Hospital | Zhengzhou | Henan | 450000 | China |
| Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology | Wuhan | Hubei | 430030 | China |
| Jiangsu Province Hospital | Nanjing | Jiangsu | 210029 | China |
| Fudan University Shanghai Cancer Center | Shanghai | Shanghai Municipality | 200000 | China |
| West China Hospital, Sichuan University | Chengdu | Sichuan | 610041 | China |
| Tianjin Medical University Cancer Institute and Hospital | Tianjin | Tianjin Municipality | 300060 | China |
| Zhejiang Cancer Hospital | Hangzhou | Zhejiang | 310022 | China |
| Fakultni Nemocnice Brno | Brno | 625 00 | Czechia |
| Fakultni Nemocnice Hradec Kralove | Hradec Králové | 500 03 | Czechia |
| Slezska Nemocnice V Opave | Opava | 746 01 | Czechia |
| Vseobecna Fakultni Nemocnice V Praze | Prague | 10000 | Czechia |
| Centre Hospitalier Universitaire Damiens Hopital Sud | Amiens | 80054 | France |
| Centre de Lutte Contre Le Cancer Institut Bergonie | Bordeaux | 33000 | France |
| Centre Hospitalier de Dunkerque | Dunkirk | 59240 | France |
| Clinique Louis Pasteur | Esseylesnancy | 54270 | France |
| Necker University Hospital | Paris | 75015 | France |
| Chu Bordeaux Hopital Haut Leveque | Pessac | 33600 | France |
| Chu Hopital Lyon Sud | PierreBenite | 69495 | France |
| Centre Hospitalier Universitaire de Poitier Hopital de La Miletrie Hopital Jean Bernard | Poitiers | 86000 | France |
| Centre Henri Becquerel | Rouen | 76038 | France |
| Universitatsklinikum Augsburg | Augsburg | 86156 | Germany |
| Azienda Ospedaliera Policlinico Di Bari | Bari | 70124 | Italy |
| Policlinico Sorsola Malpighi, Aou Di Bologna | Bologna | 40138 | Italy |
| Ospedale San Raffaele | Milan | 20132 | Italy |
| Istituto Europeo Di Oncologia | Milan | 20141 | Italy |
| Azienda Ospedaliero Universitaria Di Parma | Parma | 43126 | Italy |
| Unita Di Ematologia, Dipartimento Di Ematologia Ed Oncologia | Ravenna | 48121 | Italy |
| Ospedale Di Circolo E Fondazione Macchi | Varese | 21100 | Italy |
| Auckland City Hospital | Auckland | 1023 | New Zealand |
| Aotearoa Clinical Trials | Auckland | 2025 | New Zealand |
| Christchurch Hospital | Christchurch | 8011 | New Zealand |
| Pratia McM Krakow | Krakow | 30-727 | Poland |
| Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M Kopernika W Lodzi | Lodz | 93-513 | Poland |
| Centrum Onkologii Ziemi Lubelskiej | Lublin | 20-090 | Poland |
| Szpital Wojewodzki W Opolu | Opole | 45-372 | Poland |
| State Healthcare Institution Oncologic Dispensary No Health Department of Krasnodar Region | Sochi | Krasnodarskiy Kray | 354000 | Russia |
| N N Blokhin Russian Cancer Research Center Konstantin Laktionov | Moscow | Moscow | 115478 | Russia |
| Central City Hospital | Yekaterinburg | Sverdlovsk Oblast | 620137 | Russia |
| Kyungpook National University Hospital | Junggu | Daegu Gwang'yeogsi | 41944 | South Korea |
| Seoul National University Bundang Hospital | BundangGu SeongnamSi | Gyeonggi-do | 13620 | South Korea |
| Samsung Medical Center | GangnamGu | Seoul Teugbyeolsi | 06351 | South Korea |
| The Catholic University of Korea, Seoul St Marys Hospital | SeochoGu | Seoul Teugbyeolsi | 06591 | South Korea |
| Institut Catala Doncologia | Barcelona | 08908 | Spain |
| Hospital Universitario Puerta Del Mar | Cadiz | 11009 | Spain |
| Md Anderson Cancer Center Madrid Spain | Madrid | 28033 | Spain |
| Hospital Universitario de Octubre | Madrid | 28041 | Spain |
| Hospital Universitario Ramon Y Cajal | Madrid | 28048 | Spain |
| Hospital Universitario Puerta de Hierro Majadahonda | Majadahonda | 28222 | Spain |
| Hospital Universitario Quironsalud Madrid | Pozuelo de Alarcón | 28223 | Spain |
| Hospital Universitario de Salamanca | Salamanca | 37007 | Spain |
| Kaohsiung Medical University Chung Ho Memorial Hospital | Kaohsiung City | 807 | Taiwan |
| National Cheng Kung University Hospital | North Dist | 704 | Taiwan |
| Taipei Medical University Shuang Ho Hospital | Zhonghe Dist | 235041 | Taiwan |
| National Taiwan University Hospital West Campus | Zhongzheng Dist | 10048 | Taiwan |
| The Royal Bournemouth and Christchurch Hospitals Nhs Foundation | Bournemouth | BH7 7DW | United Kingdom |
| The Leeds Teaching Hospitals Nhs Trust | Leeds | LS9 7TF | United Kingdom |
| Barts Health Nhs Trust | London | EC1A 7BE | United Kingdom |
| Norfolk and Norwich University Hospitals Nhs Foundation Trust | Norwich | NR4 7UY | United Kingdom |
| 37506346 | Result | Zinzani PL, Mayer J, Flowers CR, Bijou F, De Oliveira AC, Song Y, Zhang Q, Merli M, Bouabdallah K, Ganly P, Zhang H, Johnson R, Martin Garcia-Sancho A, Provencio Pulla M, Trneny M, Yuen S, Tilly H, Kingsley E, Tumyan G, Assouline SE, Auer R, Ivanova E, Kim P, Huang S, Delarue R, Trotman J. ROSEWOOD: A Phase II Randomized Study of Zanubrutinib Plus Obinutuzumab Versus Obinutuzumab Monotherapy in Patients With Relapsed or Refractory Follicular Lymphoma. J Clin Oncol. 2023 Nov 20;41(33):5107-5117. doi: 10.1200/JCO.23.00775. Epub 2023 Jul 28. |
| Result | Zinzani PL, Mayer J, Trotman J, et al. Zanubrutinib Plus Obinutuzumab Versus Obinutuzumab in Patients With Relapsed/Refractory Follicular Lymphoma: Updated Analysis of the ROSEWOOD Study. Oral presentation at: 17th International Conference on Malignant Lymphoma; June, 2023; Lugano, Switzerland. https://doi.org/10.1002/hon.3163_81 |
| Result | Trotman J, Zinzani PL Mayer J, et al. Zanubrutinib Plus Obinutuzumab Versus Obinutuzumab in Patients With Relapsed/Refractory Follicular Lymphoma: Updated Analysis of the ROSEWOOD Study. Poster presented at: European Hematology Association; June, 2023; Frankfurt, Germany. |
| Result | Flowers CR, Zinzani PL, Mayer J, et al. Zanubrutinib Plus Obinutuzumab Versus Obinutuzumab in Patients With Relapsed or Refractory Follicular Lymphoma: Updated Analysis of the ROSEWOOD Study. Poster presented at: 2023 ASCO Annual Meeting; June, 2023; Chicago, IL. https://doi.org/10.1200/JCO.2023.41.16_suppl.7545 |
| Result | Gaballa S, Xue M, Swami S, et al. Cost-effectiveness of Zanubrutinib + Obinutuzumab for Treatment of Relapsed or Refractory Follicular Lymphoma in the United States. Poster presented at: International Society for Pharmacoeconomics and Outcomes Research Europe 2024; November, 2024; Barcelona, Spain. https://www.ispor.org/heor-resources/presentations-database/presentation/intl2024-3896/136274 http://reg2022.csco.org.cn/24?lang=en |
| 39376156 | Derived | Trotman J, Zinzani PL, Song Y, Delarue R, Kim P, Ivanova E, Korde R, Mayer J, De Oliveira AC, Assouline SE, Flowers CR, Barnes G. Patient-reported outcomes in patients with relapsed or refractory follicular lymphoma treated with zanubrutinib plus obinutuzumab versus obinutuzumab monotherapy: results from the ROSEWOOD trial. Curr Med Res Opin. 2024 Nov;40(11):1863-1871. doi: 10.1080/03007995.2024.2409837. Epub 2024 Oct 14. |
| FG001 | Zanubrutinib + Obinutuzumab | Zanubrutinib 160 mg twice a day orally with or without food and obinutuzumab 1000 mg intravenously on Days 1, 8, and 15 of Cycle 1, Day 1 of Cycles 2 to 6, and then every 8 weeks for an additional 24 months or until disease progression. Each treatment cycle was 28 days. |
| Treated |
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| Crossover to Combination Treatment |
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| COMPLETED |
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| NOT COMPLETED |
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Intent-to-Treat (ITT) analysis set includes all randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Obinutuzumab | Obinutuzumab 1000 milligrams (mg) intravenously on Days 1, 8, and 15 of Cycle 1, Day 1 of Cycles 2 to 6; and then every 8 weeks for an additional 24 months or until disease progression. Each treatment cycle was 28 days. |
| BG001 | Zanubrutinib + Obinutuzumab | Zanubrutinib 160 mg twice a day orally with or without food and obinutuzumab 1000 mg intravenously on Days 1, 8, and 15 of Cycle 1, Day 1 of Cycles 2 to 6, and then every 8 weeks for an additional 24 months or until disease progression. Each treatment cycle was 28 days. |
| 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, Continuous | Mean | Standard Deviation | 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/Ethnicity, Customized | 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Overall Response Rate (ORR) by Independent Central Review (ICR) Assessment | ORR was defined as the percentage of participants who achieved a best overall response of complete response (CR) or partial response (PR) per the Lugano Classification for Non-Hodgkin's Lymphoma. | Intent-To-Treat (ITT) analysis set includes all randomized participants. | Posted | Number | 95% Confidence Interval | percentage of participants | From first dose to primary analysis data cutoff (08OCT2021) start of a new anticancer therapy, or the crossover date, whichever came first. Median follow-up was 12.45 months. |
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| Secondary | Overall Response Rate (ORR) as Assessed by the Investigator | ORR was defined as the percentage of participants who achieved a best overall response of complete response (CR) or partial response (PR) per the Lugano Classification for Non-Hodgkin's Lymphoma. | ITT Analysis Set | Posted | Number | 95% Confidence Interval | Percentage of Participants | From first dose to primary analysis data cutoff (08OCT2021) start of a new anticancer therapy, or the crossover date, whichever came first. Median follow-up was 12.45 months. |
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| Secondary | Duration of Response (DOR) as Determined by Investigator Assessment | DOR was defined as the time from the date that a confirmed response (CR or PR) was first observed to the date of first documented disease progression or death, whichever occurred first. For participants in the monotherapy arm who crossed over to combination therapy, disease assessments after crossover were not included in the DOR calculation. Median DOR was estimated using the Kaplan-Meier method. | The ITT analysis set for this endpoint only included participants with a confirmed response (CR or PR) before disease progression per investigator assessment. | Posted | Median | 95% Confidence Interval | Months | From first dose to primary analysis data cutoff (08OCT2021) start of a new anticancer therapy, or the crossover date, whichever came first. Median follow-up was 12.45 months. |
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| Secondary | DOR as Determined by ICR | DOR was defined as the time from the date that a confirmed response (CR or PR) was first observed to the date of first documented disease progression or death, whichever occurred first. For participants in the monotherapy arm who crossed over to combination therapy, disease assessments after crossover were not included in the DOR calculation. Median DOR was estimated using the Kaplan-Meier method. | The ITT analysis set for this endpoint only included participants with a confirmed (CR or PR) per ICR assessment. | Posted | Median | 95% Confidence Interval | Months | From first dose to primary analysis data cutoff (08OCT2021) start of a new anticancer therapy, or the crossover date, whichever came first. Median follow-up was 12.45 months. |
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| Secondary | Progression-free Survival (PFS) | PFS was defined as the time from randomization to the date of first documented disease progression or death from any cause, whichever occurred first, as determined by the ICR or investigator assessment. For participants in the monotherapy arm who crossed over to combination therapy, disease assessments after crossover were not included in the PFS calculation. Median PFS was estimated using the Kaplan-Meier method. | ITT Analysis Set | Posted | Median | 95% Confidence Interval | Months | From first dose to primary analysis data cutoff (08OCT2021) start of a new anticancer therapy, or the crossover date, whichever came first. Median follow-up was 12.45 months. |
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| Secondary | Overall Survival (OS) | OS was defined as the time from randomization to the date of death from any cause. Median OS was estimated using the Kaplan-Meier method. | ITT Analysis Set | Posted | Median | 95% Confidence Interval | Months | From first dose to primary analysis data cutoff (08OCT2021) start of a new anticancer therapy, or the crossover date, whichever came first. Median follow-up was 12.45 months. |
|
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| Secondary | Complete Response Rate | CRR was defined as the percentage of participants who achieved a complete response or complete metabolic response as their best overall response, as determined by ICR and investigator assessment. Responses were assessed from randomization until the data cutoff date, the start of a new anticancer therapy, or the crossover date for participants in the monotherapy arm who switched to combination therapy. | ITT Analysis Set | Posted | Number | 95% Confidence Interval | Percentage of Participants | From first dose to primary analysis data cutoff (08OCT2021) start of a new anticancer therapy, or the crossover date, whichever came first. Median follow-up was 12.45 months. |
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| Secondary | Time to Response (TTR) | TRR was defined as the time from randomization to the first date that response criteria (CR or PR) were met, as determined by ICR and investigator assessment. Only participants who achieved an overall response were included in the analysis. For participants in the monotherapy arm who crossed over to combination therapy, disease assessments after crossover were not included in the TRR calculation. | ITT Analysis Set. Only participants who achieved an overall response were included in the analysis. | Posted | Median | Full Range | Months | From first dose to primary analysis data cutoff (08OCT2021) start of a new anticancer therapy, or the crossover date, whichever came first. Median follow-up was 12.45 months. |
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| Secondary | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status (GHS)/Quality of Life (QOL), Physical Functioning, Role Functioning, and Symptom Scores | The EORTC QLQ-C30 includes 30 questions covering 5 functional scales (physical, role, emotional, cognitive, social), 1 global health scale, 3 symptom scales (fatigue, nausea/vomiting, pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). Participants report their health over the past week. Most items use a 4-point scale (1 = Not at all to 4 = Very much), while 2 global QOL items use a 7-point scale (1 = Very poor to 7 = Excellent). Raw scores are linearly transformed to a 0-100 scale; higher GHS and functional scores and lower symptom scores indicate better quality of life. | ITT Analysis Set. Only participants with data at both baseline and each post-baseline visit were included in the calculation of change from baseline. | Posted | Mean | Standard Deviation | Score on a scale | Baseline, Week 12, and Week 24 |
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| Secondary | Change From Baseline in European Quality of Life 5-Dimensions, 5-level (EQ-5D-5L) Visual Analogue Scale (VAS) | The EQ-5D-5L measures health outcomes using a VAS to record a participant's self-rated health on a scale from 0 to 100, where 100 is 'the best health you can imagine' and 0 is 'the worst health you can imagine.' A higher score indicates better health outcomes. | ITT Analysis Set; Only participants with data at both baseline and each post-baseline visit were included in the calculation of change from baseline. | Posted | Mean | Standard Deviation | Score on a scale | Baseline, Week 12, and Week 24 |
|
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| Secondary | Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | An adverse event refers to any unintended or unfavorable sign, symptom, or condition (including abnormal lab results) that occurs during the study, regardless of whether it is linked to the study drug. | The Safety Analysis Set includes all participants in the ITT Analysis Set who received any dose of any study drug | Posted | Count of Participants | Participants | From first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy. |
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| Secondary | Area Under the Curve (AUCss) of Zanubrutinib at Steady State | Pharmacokinetic exposure parameters were estimated for each participant using a population pharmacokinetic (PK) model. | The PK Analysis Set included all zanubrutinib-treated participants with ≥1 post-baseline PK concentration (n=142). Concentrations were excluded per prespecified rules (missing/invalid times, pre-dose values, peak-trough switches, and outliers), resulting in 137 participants with reported PK parameters. | Posted | Mean | Standard Deviation | nanogram·hour per milliliter (ng·h/mL) | Cycle 1 Day 1 and Cycle 2 Day 1: Predose (within 30 minutes before zanubrutinib dosing) and 2 hours (± 30 minutes) post-dose. |
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| Secondary | Zanubrutinib Plasma Concentrations | The Pharmacokinetics (PK) Analysis Set included all zanubrutinib-treated participants who had at least one post-baseline PK concentration measurement. | Posted | Mean | Standard Deviation | nanograms per milliliter (ng/ml) | Cycle 1 Day 1 and Cycle 2 Day 1: Predose (within 30 minutes before zanubrutinib dosing) and 2 hours (± 30 minutes) post-dose. |
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| Secondary | Minimum Observed Concentration (Cmin) of Zanubrutinib at Steady State | Pharmacokinetic exposure parameters were estimated for each participant using a population pharmacokinetic (PK) model. | The PK Analysis Set included all zanubrutinib-treated participants with ≥1 post-baseline PK concentration (n=142). Concentrations were excluded per prespecified rules (missing/invalid times, pre-dose values, peak-trough switches, and outliers), resulting in 137 participants with reported PK parameters. concentration measurement. | Posted | Mean | Standard Deviation | nanograms per milliliter (ng/ml) | Cycle 1 Day 1 and Cycle 2 Day 1: Predose (within 30 minutes before zanubrutinib dosing) and 2 hours (± 30 minutes) post-dose. |
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| Secondary | Maximum Observed Concentration (Cmax) of Zanubrutinib at Steady State | The Pharmacokinetics (PK) Analysis Set included all zanubrutinib-treated participants who had at least one post-baseline PK concentration measurement. | Posted | Mean | Standard Deviation | nanograms per milliliter (ng/ml) | Cycle 1 Day 1 (2 hours postdose) and Cycle 2 Day 1 (predose and 2 hours postdose) |
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| Post-Hoc | Duration of Response (DOR) as Determined by ICR | Per the Food and Drug Adminstrations's request, an additional analysis of DOR was conducted 12 months after the last participant was randomized. DOR was defined as the time from the date that a confirmed response (CR or PR) was first observed to the date of first documented disease progression or death, whichever occurred first. For participants in the monotherapy arm who crossed over to combination therapy, disease assessments after crossover were not included in the DOR calculation. Median DOR was estimated using the Kaplan-Meier method. | Participants in the ITT analysis set with a confirmed complete response (CR) or partial response (PR) per ICR assessment at the updated post-hoc analysis data cutoff (25 JUN 2022). | Posted | Median | 95% Confidence Interval | Months | From first dose to updated analysis data cutoff (25JUN2022) start of a new anticancer therapy, or the crossover date, whichever came first. Median follow-up time was 20.21 months. |
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| Post-Hoc | DOR as Determined by Investigator | Per the Food and Drug Adminstrations's request, an additional analysis of DOR was conducted 12 months after the last participant was randomized. DOR was defined as the time from the date that a confirmed response (CR or PR) was first observed to the date of first documented disease progression or death, whichever occurred first. For participants in the monotherapy arm who crossed over to combination therapy, disease assessments after crossover were not included in the DOR calculation. Median DOR was estimated using the Kaplan-Meier method. | Participants in the ITT analysis set with a confirmed complete response (CR) or partial response (PR) per investigator assessment at the updated post-hoc analysis data cutoff (25 JUN 2022). | Posted | Median | 95% Confidence Interval | Months | From first dose to updated analysis data cutoff (25JUN2022) start of a new anticancer therapy, or the crossover date, whichever came first. Median follow-up time was 20.21 months. |
|
All-cause mortality was reported up to the end of study, max time on study was approximately 70 months. AEs were reported from first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off date (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 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 | Obinutuzumab Monotherapy | Obinutuzumab 1000 milligrams (mg) intravenously on Days 1, 8, and 15 of Cycle 1, Day 1 of Cycles 2 to 6; and then every 8 weeks for an additional 24 months or until disease progression. Each treatment cycle was 28 days. | 33 | 72 | 22 | 71 | 62 | 71 |
| EG001 | Zanubrutinib Plus Obinutuzumab | Zanubrutinib 160 mg twice a day orally with or without food and obinutuzumab 1000 mg intravenously on Days 1, 8, and 15 of Cycle 1, Day 1 of Cycles 2 to 6, and then every 8 weeks for an additional 24 months or until disease progression. Each treatment cycle was 28 days. | 51 | 145 | 75 | 143 | 130 | 143 |
| EG002 | Crossover Treatment | Participants in teh obinutuzumab monotherapy arm who experienced progressive disease or their disease did not respond to therapy after 12 months (confirmed by the independent central review) crossed over to receive zanubrutinib 160 mg twice a day orally in addition to obinutuzumab 1000 mg intravenously every 8 weeks for a maximum of 30 months or until disease progression at the investigator's discretion. | 16 | 36 | 20 | 36 | 32 | 36 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Necrotic lymphadenopathy | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Aortic valve stenosis | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Malignant gastrointestinal obstruction | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Retroperitoneal haematoma | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Spigelian hernia | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Swelling face | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Portal vein thrombosis | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Abdominal infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Arthritis bacterial | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Bronchopulmonary aspergillosis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Candida infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Complicated appendicitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Device related sepsis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Escherichia urinary tract infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Gastrointestinal viral infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| HCoV-OC43 infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Hepatitis E | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Mastoiditis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Myelitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Nail infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Oesophageal candidiasis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Otitis externa | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Pulmonary mucormycosis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Staphylococcal bacteraemia | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Staphylococcal sepsis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Upper respiratory tract infection bacterial | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Urinary tract infection bacterial | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Varicella | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Vascular access site infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Barotitis media | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Cervical vertebral fracture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Foreign body in gastrointestinal tract | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Gastroenteritis radiation | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Amylase increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Tumour lysis syndrome | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Intervertebral disc space narrowing | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Acute lymphocytic leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| Acute myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| Adenocarcinoma pancreas | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| Invasive ductal breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| Meningioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| Metastatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| Facial nerve disorder | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Completed suicide | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pulmonary mass | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Extremity necrosis | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Anal incontinence | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Gingival bleeding | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypogammaglobulinaemia | Immune system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| SARS-CoV-2 test positive | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Post herpetic neuralgia | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
|
BeiGene has 18 months from the end of the study at all sites to publish overall study results. After the 1st multi-site publication or the expiration of publication period, Investigators are free to publish/present the results of the study. Investigators must submit all draft publications/presentations to us for review 60 days prior to the planned publication/presentation date. BeiGene may request deletion of its confidential information & may request a further delay to protect its IP rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | BeiGene | +1-877-828-5568 | clinicaltrials@beigene.com |
| Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 19, 2022 | Dec 12, 2025 | SAP_003.pdf |
| 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 |
|---|---|
| C000629551 | zanubrutinib |
| C543332 | obinutuzumab |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Not Reported |
|
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