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| ID | Type | Description | Link |
|---|---|---|---|
| CTR20170965 | Registry Identifier | China Drug Trials (CDT) |
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This was a multicenter, open-label, phase 2 study to evaluate efficacy, safety, and tolerability of BGB-3111 (zanubrutinib) 160 milligrams (mg) twice daily (BID) in combination with rituximab in Chinese participants with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) (non-GCB [non-germinal center B-cell-like] subtype) and R/R indolent lymphoma (follicular lymphoma [FL] and marginal zone lymphoma [MZL]).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| R/R Non-GCB DLBCL | Experimental | Participants with non-GCB DLBCL received zanubrutinib plus rituximab for up to progressive disease or intolerance. |
|
| R/R FL or MZL | Experimental | Participants with R/R FL or MZL received zanubrutinib plus rituximab for up to progressive disease or intolerance. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zanubrutinib | Drug | Administered zanubrutinib 160 mg orally (PO) BID continuously |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) As Measured By The Investigator | The percentage of participants whose best overall response met partial response (PR) or complete response (CR) criteria among all participants. The 95% confidence interval (CI) was calculated with the Clopper-Pearson method. | Up to approximately 2.5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Duration Of Response (DOR) As Determined By Investigator | The DOR was defined as the time from the date that the response criteria were first met to the date that progressive disease (PD) was objectively documented or death, whichever occurred first. Medians were estimated by the Kaplan-Meier method with 95% CIs estimated using the Brookmeyer and Crowley method. | Up to approximately 2.5 years |
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Key Inclusion Criteria:
≥ Age 18 years at time of signing of informed consent.
Measurable disease by computed tomography (CT) or positron emission tomography/CT or magnetic resonance imaging, defined as ≥1 nodal lesion that was >1.5 centimeters (cm) in the longest diameter, or ≥1 extra-nodal lesion (for example, hepatic nodules) that was >1 cm in the longest diameter.
Availability of archival or fresh tumor tissue sample from an evaluable core or excisional biopsy.
Participants meet the following criteria:
Laboratory parameters as specified below:
Left ventricular ejection fraction ≥50%.
Life expectancy ≥6 months.
Eastern Cooperative Oncology Group performance status of 0, 1, or 2.
Female participants of childbearing potential must have practiced highly effective methods of contraception initiated prior to first dose of study drug, for the duration of the study, and for ≥90 days after the last dose of zanubrutinib, or 12 months after the last dose of rituximab, whichever is longer.
Male participants were eligible if vasectomized or if they agreed to the use of barrier contraception in combination with other methods above during the study treatment period and for ≥90 days after the last dose of zanubrutinib.
Able to provide written informed consent and could understand and comply with the requirements of the study.
Key Exclusion Criteria:
Known central nervous system lymphoma or leukemia.
Histological confirmed gastric mucosa-associated lymphoid tissue type MZL.
Uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenia purpura.
Clinically significant cardiovascular disease.
History of severe bleeding disorder such as hemophilia A, hemophilia B, von Willebrand disease, or history of spontaneous bleeding requiring blood transfusion or other medical intervention.
History of stroke or intracranial hemorrhage within 6 months before first dose of study drug.
Severe or debilitating pulmonary disease.
Hypersensitivity reaction to zanubrutinib or rituximab or any of the other ingredients of the study drugs.
Prior Bruton tyrosine kinase inhibitor treatment.
Required ongoing treatment with a strong cytochrome P450 protein inhibitor or inducer.
Vaccination with a live vaccine within 28 days of the first dose of study drug.
Hematopoietic stem cell transplantation within 6 months of first dose of study drug.
Receipt of the following treatment prior to first dose of study drug:
Not recovered from toxicity of any prior anti-cancer therapy to ≤Grade 1, except for alopecia, ANC, hemoglobin (Hgb), and platelets. For ANC, Hgb and platelets, see inclusion criterion #5.
Prior malignancy within the past 3 years, except for curatively treated basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast.
Unable to swallow capsules or disease significantly affecting gastrointestinal function such as malabsorption syndrome, resection of the stomach or small bowel, symptomatic inflammatory bowel disease, history of bariatric surgery, or partial or complete bowel obstruction.
Major surgery within 4 weeks prior to first dose of study treatment.
Active fungal, bacterial and/or viral infection requiring systemic therapy.
Known infection with human immunodeficiency virus, or serologic status reflecting active hepatitis B or C infection as follows:
Pregnant or lactating women.
Underlying medical conditions that, in the investigator's opinion, would have rendered the administration of study drug hazardous or obscure the interpretation of toxicity or adverse events.
Concurrent participation in another therapeutic clinical trial.
Note: Other protocol defined Inclusion/Exclusion criteria may have applied.
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | BeiGene | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harbin Medical University Cancer Hospital | Harbin | Heilongjiang | 150000 | China | ||
| Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Qingyuan Zhang, Rong Tao, Zhenyu Li, et al. Zanubrutinib (BGB-3111) in combination with rituximab in patients with relapsed/refractory Non-Hodgkin Lymphoma [EHA-2188]. | ||
| 38775302 | Derived | Liu Y, Ma X, Wu X, Hou X, Jin W, Fu L, Xun X, Yu Y, Shen Z. Zanubrutinib is effective in non-germinal-center B-cell-like diffuse large B-cell lymphoma with mutated CD79B, high TCL1A expression, or over- expressed MYC/BCL-2. Leuk Lymphoma. 2024 Aug;65(8):1079-1089. doi: 10.1080/10428194.2024.2343779. Epub 2024 May 22. |
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This study was conducted at 4 study centers in China, all of which enrolled participants. The first enrolled participants received their first dose on 04 January 2018, and the last participant enrolled received their first dose on 20 December 2018. A total of 41 participants with non-Hodgkin lymphoma (NHL) were enrolled into the study, and all received ≥1 dose of study treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Relapsed/Refractory Non-germinal Center B-cell-like Diffuse Large B-cell Lymphoma | Participants with relapsed/refractory (R/R) non-germinal center B-cell-like diffuse large B-cell lymphoma (non-GCB DLBCL) received zanubrutinib plus rituximab for up to progressive disease or intolerance. Administered zanubrutinib 160 milligrams (mg) orally (PO) twice daily (BID) continuously and rituximab 375 mg/meter squared (m^2) intravenously (IV) on Cycle 1 Days 1, 8, 15, 22, and on Day 1 of Cycles 4, 6, 8, 10. Each cycle was 28 days long. |
| 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 | Mar 28, 2019 | Aug 26, 2021 |
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| Rituximab | Drug | Administered rituximab 375 mg/m^2 intravenously on Cycle 1 Days 1, 8, 15, 22, and on Day 1 of Cycles 4, 6, 8, 10. Each cycle was 28 days long. |
|
| DOR: Event-free Rate | The DOR was defined as the time from the date that the response criteria were first met to the date that progressive disease (PD) was objectively documented or death, whichever occurred first. The event-free rate was estimated by the Kaplan-Meier method with 95% CIs estimated using Greenwood's formula. | Up to approximately 2.5 years |
| Progression-free Survival (PFS) As Determined By Investigator | The PFS was defined as time from first dose of study treatment until first documentation of progression, assessed per the Lugano Classification, or death, whichever occurred first. Medians were estimated by the Kaplan-Meier method with 95% CIs estimated using the Brookmeyer and Crowley method. | Up to approximately 2.5 years |
| PFS: Event-free Rate | The PFS was defined as time from first dose of study treatment until first documentation of progression, assessed per the Lugano Classification, or death, whichever occurred first. The event-free rate was estimated by the Kaplan-Meier method with 95% CIs estimated using Greenwood's formula. | Up to approximately 2.5 years |
| Overall Survival (OS) | The OS was defined as the time from the date of first dose of study treatment to the date of death due to any cause. Medians were estimated by the Kaplan-Meier method with 95% CIs estimated using the method of Brookmeyer and Crowley. | Up to approximately 2.5 years |
| OS: Survival Rate | The OS was defined as the time from the date of first dose of study treatment to the date of death due to any cause. Survival rates were estimated by the Kaplan-Meier method with 95% CIs estimated using Greenwood's formula. | Up to approximately 2.5 years |
| Time To Response (TTR) As Determined By The Investigator | The TTR was defined as the time from the date of the first dose of study treatment to the date of the first qualifying response (partial response or better). | Up to approximately 2.5 years |
| Median TTR | The TTR was defined as the time from the date of the first dose of study treatment to the date of the first qualifying response (partial response or better). | Up to approximately 2.5 years |
| Complete Response Rate As Determined By The Investigator | The percentage of participants whose best overall response met complete response or complete metabolic response criteria among all participants are reported. The 95% CI was calculated with Clopper-Pearson method. | Up to approximately 2.5 years |
| Number Of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) And Serious TEAEs | A treatment-emergent adverse event was defined as an adverse event with an onset or worsening (if present pretreatment) starting on or after the first dose of study drug up to 30 days after discontinuation of zanubrutinib or 90 days after discontinuation of rituximab, whichever occurred later; or initiation of new anticancer therapy if it occurred prior to the other 2 dates. Worsening of a treatment-emergent adverse event to Grade 5 beyond Day 30 after the last dose of zanubrutinib or Day 90 after the last dose rituximab was also considered a treatment-emergent adverse event if the event occurred prior to initiation of new anticancer therapy. | Up to approximately 2.5 years |
| Wuhan |
| Hubei |
| 430030 |
| China |
| The Affiliated Hospital of Xuzhou Medical University | Xuzhou | Jiangsu | 221000 | China |
| Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine | Shanghai | Shanghai Municipality | 200092 | China |
| FG001 | Relapsed/Refractory Follicular Lymphoma | Participants with R/R follicular lymphoma (FL) received zanubrutinib plus rituximab for up to progressive disease or intolerance. Administered zanubrutinib 160 mg PO BID continuously and rituximab 375 mg/m^2 IV on Cycle 1 Days 1, 8, 15, 22, and on Day 1 of Cycles 4, 6, 8, 10. Each cycle was 28 days long. |
| FG002 | Relapsed/Refractory Marginal Zone Lymphoma | Participants with R/R marginal zone lymphoma (MZL) received zanubrutinib plus rituximab for up to progressive disease or intolerance. Administered zanubrutinib 160 mg PO BID continuously and rituximab 375 mg/m^2 IV on Cycle 1 Days 1, 8, 15, 22, and on Day 1 of Cycles 4, 6, 8, 10. Each cycle was 28 days long. |
| Received at Least 1 Dose of Study Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Relapsed/Refractory Non-germinal Center B-cell-like Diffuse Large B-cell Lymphoma | Participants with R/R non-GCB DLBCL received zanubrutinib plus rituximab for up to progressive disease or intolerance. Administered zanubrutinib 160 mg PO BID continuously and rituximab 375 mg/m^2 IV on Cycle 1 Days 1, 8, 15, 22, and on Day 1 of Cycles 4, 6, 8, 10. Each cycle was 28 days long. |
| BG001 | Relapsed/Refractory Follicular Lymphoma | Participants with R/R FL received zanubrutinib plus rituximab for up to progressive disease or intolerance. Administered zanubrutinib 160 mg PO BID continuously and rituximab 375 mg/m^2 IV on Cycle 1 Days 1, 8, 15, 22, and on Day 1 of Cycles 4, 6, 8, 10. Each cycle was 28 days long. |
| BG002 | Relapsed/Refractory Marginal Zone Lymphoma | Participants with R/R MZL received zanubrutinib plus rituximab for up to progressive disease or intolerance. Administered zanubrutinib 160 mg PO BID continuously and rituximab 375 mg/m^2 IV on Cycle 1 Days 1, 8, 15, 22, and on Day 1 of Cycles 4, 6, 8, 10. Each cycle was 28 days long. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Body Mass Index | Mean | Standard Deviation | kilogram/m^2 |
| |||||||||||||||
| Body Surface Area | Mean | Standard Deviation | m^2 |
| |||||||||||||||
| Eastern Cooperative Oncology Group Performance (ECOG)Status | ECOG Performance Status - Grade 0 = Fully active, able to carry on all pre-disease performance without restriction; Grade 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, eg, light house work, office work; Grade 2 = Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours | Count of Participants | Participants |
| |||||||||||||||
| Hepatitis B Core Antibody | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Overall Response Rate (ORR) As Measured By The Investigator | The percentage of participants whose best overall response met partial response (PR) or complete response (CR) criteria among all participants. The 95% confidence interval (CI) was calculated with the Clopper-Pearson method. | Safety Analysis Set included all participants who received at least 1 dose of study drug (zanubrutinib or rituximab) on the study. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to approximately 2.5 years |
|
|
| |||||||||||||||||||||||||||||||
| Secondary | Duration Of Response (DOR) As Determined By Investigator | The DOR was defined as the time from the date that the response criteria were first met to the date that progressive disease (PD) was objectively documented or death, whichever occurred first. Medians were estimated by the Kaplan-Meier method with 95% CIs estimated using the Brookmeyer and Crowley method. | Safety Analysis Set included all participants who received at least 1 dose of study drug (zanubrutinib or rituximab) on the study. Duration of response was summarized for responders (participants with a best response of partial response or higher) only. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 2.5 years |
| |||||||||||||||||||||||||||||||||
| Secondary | DOR: Event-free Rate | The DOR was defined as the time from the date that the response criteria were first met to the date that progressive disease (PD) was objectively documented or death, whichever occurred first. The event-free rate was estimated by the Kaplan-Meier method with 95% CIs estimated using Greenwood's formula. | The Safety Analysis Set included all participants who received at least 1 dose of study drug (zanubrutinib or rituximab). | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to approximately 2.5 years |
| |||||||||||||||||||||||||||||||||
| Secondary | Progression-free Survival (PFS) As Determined By Investigator | The PFS was defined as time from first dose of study treatment until first documentation of progression, assessed per the Lugano Classification, or death, whichever occurred first. Medians were estimated by the Kaplan-Meier method with 95% CIs estimated using the Brookmeyer and Crowley method. | The Safety Analysis Set included all participants who received at least 1 dose of study drug (zanubrutinib or rituximab). | Posted | Median | 95% Confidence Interval | Months | Up to approximately 2.5 years |
| |||||||||||||||||||||||||||||||||
| Secondary | PFS: Event-free Rate | The PFS was defined as time from first dose of study treatment until first documentation of progression, assessed per the Lugano Classification, or death, whichever occurred first. The event-free rate was estimated by the Kaplan-Meier method with 95% CIs estimated using Greenwood's formula. | The Safety Analysis Set included all participants who received at least 1 dose of study drug (zanubrutinib or rituximab). | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to approximately 2.5 years |
| |||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | The OS was defined as the time from the date of first dose of study treatment to the date of death due to any cause. Medians were estimated by the Kaplan-Meier method with 95% CIs estimated using the method of Brookmeyer and Crowley. | The Safety Analysis Set included all participants who received at least 1 dose of study drug (zanubrutinib or rituximab). | Posted | Median | 95% Confidence Interval | Months | Up to approximately 2.5 years |
| |||||||||||||||||||||||||||||||||
| Secondary | OS: Survival Rate | The OS was defined as the time from the date of first dose of study treatment to the date of death due to any cause. Survival rates were estimated by the Kaplan-Meier method with 95% CIs estimated using Greenwood's formula. | The Safety Analysis Set included all participants who received at least 1 dose of study drug (zanubrutinib or rituximab). | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to approximately 2.5 years |
| |||||||||||||||||||||||||||||||||
| Secondary | Time To Response (TTR) As Determined By The Investigator | The TTR was defined as the time from the date of the first dose of study treatment to the date of the first qualifying response (partial response or better). | The Safety Analysis Set included all participants who received at least 1 dose of study drug (zanubrutinib or rituximab). | Posted | Mean | Standard Deviation | Months | Up to approximately 2.5 years |
| |||||||||||||||||||||||||||||||||
| Secondary | Median TTR | The TTR was defined as the time from the date of the first dose of study treatment to the date of the first qualifying response (partial response or better). | The Safety Analysis Set included all participants who received at least 1 dose of study drug (zanubrutinib or rituximab). | Posted | Median | Full Range | Months | Up to approximately 2.5 years |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Complete Response Rate As Determined By The Investigator | The percentage of participants whose best overall response met complete response or complete metabolic response criteria among all participants are reported. The 95% CI was calculated with Clopper-Pearson method. | The Safety Analysis Set included all participants who received at least 1 dose of study drug (zanubrutinib or rituximab). | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to approximately 2.5 years |
| |||||||||||||||||||||||||||||||||
| Secondary | Number Of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) And Serious TEAEs | A treatment-emergent adverse event was defined as an adverse event with an onset or worsening (if present pretreatment) starting on or after the first dose of study drug up to 30 days after discontinuation of zanubrutinib or 90 days after discontinuation of rituximab, whichever occurred later; or initiation of new anticancer therapy if it occurred prior to the other 2 dates. Worsening of a treatment-emergent adverse event to Grade 5 beyond Day 30 after the last dose of zanubrutinib or Day 90 after the last dose rituximab was also considered a treatment-emergent adverse event if the event occurred prior to initiation of new anticancer therapy. | The Safety Analysis Set included all participants who received at least 1 dose of study drug (zanubrutinib or rituximab). | Posted | Count of Participants | Participants | Up to approximately 2.5 years |
|
Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Relapsed/Refractory Non-germinal Center B-cell-like Diffuse Large B-cell Lymphoma | Participants with R/R non-GCB DLBCL received zanubrutinib plus rituximab for up to progressive disease or intolerance. | 13 | 20 | 7 | 20 | 19 | 20 |
| EG001 | Relapsed/Refractory Follicular Lymphoma | Participants with R/R FL received zanubrutinib plus rituximab for up to progressive disease or intolerance. | 1 | 16 | 4 | 16 | 16 | 16 |
| EG002 | Relapsed/Refractory Marginal Zone Lymphoma | Participants with R/R MZL received zanubrutinib plus rituximab for up to progressive disease or intolerance. | 0 | 5 | 0 | 5 | 5 | 5 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymph gland infection | Infections and infestations | MedDRA Version 23.0 | Systematic Assessment |
| |
| Lymphangitis | Infections and infestations | MedDRA Version 23.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 23.0 | Systematic Assessment |
| |
| Pulmonary mycosis | Infections and infestations | MedDRA Version 23.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Death | General disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Hypoproteinaemia | Metabolism and nutrition disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Completed suicide | Psychiatric disorders | MedDRA Version 23.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| White blood cell count decreased | Investigations | MedDRA Version 23.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA Version 23.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA Version 23.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA Version 23.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA Version 23.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA Version 23.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA Version 23.0 | Systematic Assessment |
| |
| Blood urine present | Investigations | MedDRA Version 23.0 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA Version 23.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA Version 23.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 23.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA Version 23.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Purpura | Skin and subcutaneous tissue disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Haemoglobinuria | Renal and urinary disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA Version 23.0 | 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_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 11, 2020 | Aug 26, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D018442 | Lymphoma, B-Cell, Marginal Zone |
| D008224 | Lymphoma, Follicular |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| 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 |
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| ID | Term |
|---|---|
| C000629551 | zanubrutinib |
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| ≥65 years |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Grade 1 |
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| Grade 2 |
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| Negative |
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| Missing |
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| OG002 | Relapsed/Refractory Marginal Zone Lymphoma | Participants with R/R MZL received zanubrutinib plus rituximab for up to progressive disease or intolerance. Administered zanubrutinib 160 mg PO BID continuously and rituximab 375 mg/m^2 IV on Cycle 1 Days 1, 8, 15, 22, and on Day 1 of Cycles 4, 6, 8, 10. Each cycle was 28 days long. |
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Participants with R/R MZL received zanubrutinib plus rituximab for up to progressive disease or intolerance. Administered zanubrutinib 160 mg PO BID continuously and rituximab 375 mg/m^2 IV on Cycle 1 Days 1, 8, 15, 22, and on Day 1 of Cycles 4, 6, 8, 10. Each cycle was 28 days long. |
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|
Participants with R/R MZL received zanubrutinib plus rituximab for up to progressive disease or intolerance. Administered zanubrutinib 160 mg PO BID continuously and rituximab 375 mg/m^2 IV on Cycle 1 Days 1, 8, 15, 22, and on Day 1 of Cycles 4, 6, 8, 10. Each cycle was 28 days long. |
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|
Participants with R/R MZL received zanubrutinib plus rituximab for up to progressive disease or intolerance. Administered zanubrutinib 160 mg PO BID continuously and rituximab 375 mg/m^2 IV on Cycle 1 Days 1, 8, 15, 22, and on Day 1 of Cycles 4, 6, 8, 10. Each cycle was 28 days long. |
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| Participants |
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| Units | Counts |
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| Participants |
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| Relapsed/Refractory Marginal Zone Lymphoma |
Participants with R/R MZL received zanubrutinib plus rituximab for up to progressive disease or intolerance. |
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