Study to Evaluate Efficacy and Safety of BGB-3111 in Participants With Relapsed or Refractory Mantle Cell Lymphoma (MCL)
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|ClinicalTrials.gov Identifier: NCT03206970|
Recruitment Status : Completed
First Posted : July 2, 2017
Results First Posted : May 13, 2020
Last Update Posted : November 5, 2021
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|Condition or disease||Intervention/treatment||Phase|
|Refractory Mantle Cell Lymphoma Relapsed Mantle Cell Lymphoma||Drug: Zanubrutinib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||86 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Single-Arm, Open-Label, Multicenter Phase 2 Study to Evaluate Efficacy and Safety of BGB-3111, a Bruton's Tyrosine Kinase (BTK) Inhibitor, in Subjects With Relapsed or Refractory Mantle Cell Lymphoma (MCL)|
|Actual Study Start Date :||March 2, 2017|
|Actual Primary Completion Date :||February 15, 2019|
|Actual Study Completion Date :||September 8, 2020|
Zanubrutinib (160 milligrams) administered orally twice daily
Administered as specified in the treatment arm.
Other Name: BGB-3111
- Overall Response Rate (ORR) As Assessed By Independent Review Committee [ Time Frame: Up to 1 year and 11 months ]The ORR was assessed in accordance with the 2014 modification of the International Working Group on non-Hodgkin Lymphoma Criteria. The ORR was defined as the percentage of participants achieving a best overall response (BOR) of complete response (CR) or partial response (PR). The BOR was defined as the best response recorded from the start of zanubrutinib until data cut or start of new antineoplastic treatment. Participants with no post-baseline response assessment (due to any reason) were considered non-responders for BOR.
- Progression-free Survival [ Time Frame: Up to 3 years and 6 months ]Progression-free survival was defined as the time from the starting date of zanubrutinib to the date of first documentation of disease progression or death, whichever occurred first. Participants who did not have disease progression were censored at their last valid tumor assessment. A six-month progression-free survival rate was defined as no disease progression after treated with zanubrutinib for over six months (under control). The 95% confidence interval (CI) lower bound was 33.1 months while the upper bound could not be estimated.
- Time To Response [ Time Frame: Up to 3 years and 6 months ]Time to response was defined as the time from treatment initiation to the first documentation of response.
- Duration Of Response [ Time Frame: Up to 3 years and 6 months ]The duration of response was defined as the time from the date that the response criteria are first met to the date that Progressive Disease was objectively documented or death (whichever occurs first). Participants who did not have disease progression were censored at their last valid assessment.
- ORR As Assessed By The Investigator [ Time Frame: Up to 3 years and 6 months ]The ORR was assessed in accordance with the 2014 modification of the International Working Group on non-Hodgkin Lymphoma Criteria. The ORR was defined as the percentage of participants achieving a BOR of CR or PR. The BOR was defined as the best response recorded from the start of zanubrutinib until data cut or start of new antineoplastic treatment. Participants with no post-baseline response assessment (due to any reason) were considered non-responders for BOR. For this outcome measure, only investigator-assessed data are analyzed and reported because of the high rate of concordance between the Independent Review Committee and investigator assessments for the primary outcome measure of ORR.
- Number Of Participants Experiencing Treatment -Emergent Adverse Events (AEs) [ Time Frame: From the initiation of study drug until 30 days after the last dose (Up to 3 years and 6 months) ]
An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study drug, whether considered related to study drug or not. A summary of serious and all other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.
A treatment-emergent adverse event (TEAE) is defined as an AE that had an onset date or a worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days following study drug discontinuation (Safety Follow-up visit) or initiation of new anticancer therapy, whichever comes first.
- Number Of Participants Experiencing AEs Leading To Treatment Discontinuation [ Time Frame: From the initiation of study drug until 30 days after the last dose (Up to 3 years and 6 months) ]An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study drug, whether considered related to the study drug or not. A summary of serious and all other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.
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|Ages Eligible for Study:||18 Years to 75 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
Key Inclusion Criteria:
- Diagnostic report had to include evidence for morphological and cyclin D1 or t (11; 14).
- Eastern Cooperative Oncology Group performance status of 0-2.
- Measurable disease by computed tomography/magnetic resonance imaging.
- Received prior regimens for MCL.
- Documented failure to achieve any response, (stable disease or progressive disease during treatment) or documented progressive disease after response to the most recent treatment regimen.
- Aspartate aminotransferase and alanine aminotransferase ≤ 2.5 x upper limit of normal (ULN).
- Total bilirubin ≤ 2 x ULN (unless documented Gilbert's syndrome).
- Life expectancy of > 4 months.
Key Exclusion Criteria:
- Current or history of central nervous system lymphoma.
- Prior exposure to a BTK inhibitor before enrollment.
- Prior corticosteroids with anti-neoplastic intent within 7 days.
- Major surgery within 4 weeks of screening.
- Toxicity must have recovered from prior chemotherapy.
- History of other active malignancies within 2 years of study entry.
- Currently clinically significant active cardiovascular disease.
- QT interval corrected with Fridericia's formula > 450 microseconds or other significant electrocardiogram abnormalities.
- Uncontrolled systemic infection or infection requiring parenteral anti-microbial therapy.
- Known human immunodeficiency virus infection, or active hepatitis B or hepatitis C infection (detected positive by polymerase chain reaction).
Note: Other protocol-defined Inclusion/Exclusion criteria may apply.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03206970
|Beijing Cancer Hospital|
|Beijing, Beijing, China, 100142|
|Peking Union Medical College Hospital|
|Beijing, Beijing, China|
|Fujian Medical University Union Hospital|
|Fuzhou, Fujian, China|
|Nanfang Hospital of Southern Medical University|
|Guangzhou, Guangdong, China|
|Henan Cancer Province|
|Zhengzhou, Henan, China|
|Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology|
|Wuhan, Hubei, China|
|Jiangsu Province Hospital|
|Nanjing, Jiangsu, China|
|The First Affiliated Hospital of Jinlin University|
|Chang chun, Jilin, China|
|Fudan University Cancer Center|
|Shanghai, Shanghai, China|
|West China Hospital, Sichuan University|
|Chengdu, Sichuan, China|
|Blood Diseases Hospital, Chinese Academy of Medical Sciences|
|Tianjin, Tianjin, China|
|Tianjin Cancer Hospital|
|Tianjin, Tianjin, China|
|The First Affiliated Hospital, College of Medicine, Zhejiang University|
|Hangzhou, Zhejiang, China|
|Zhejiang Cancer Hospital|
|Hangzhou, Zhejiang, China|
|Principal Investigator:||Study Director||BeiGene|
Documents provided by BeiGene:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Other Study ID Numbers:||
CTR20160888 ( Registry Identifier: Center for drug evaluation, CFDA )
|First Posted:||July 2, 2017 Key Record Dates|
|Results First Posted:||May 13, 2020|
|Last Update Posted:||November 5, 2021|
|Last Verified:||October 2021|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Yes|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Neoplasms by Histologic Type
Immune System Diseases
Protein Kinase Inhibitors
Molecular Mechanisms of Pharmacological Action