This is the classic website, which will be retired eventually. Please visit the modernized ClinicalTrials.gov instead.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study to Evaluate Efficacy and Safety of BGB-3111 in Participants With Relapsed or Refractory Mantle Cell Lymphoma (MCL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03206970
Recruitment Status : Completed
First Posted : July 2, 2017
Results First Posted : May 13, 2020
Last Update Posted : November 5, 2021
Sponsor:
Information provided by (Responsible Party):
BeiGene

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The primary objective of this study was to evaluate the efficacy of zanubrutinib in participants with centrally confirmed relapsed or refractory MCL.

Condition or disease Intervention/treatment Phase
Refractory Mantle Cell Lymphoma Relapsed Mantle Cell Lymphoma Drug: Zanubrutinib Phase 2

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 86 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Zanubrutinib
Zanubrutinib (160 milligrams) administered orally twice daily
 Drug: Zanubrutinib
Administered as specified in the treatment arm.
Other Name: BGB-3111


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.


  6. 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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  1. Diagnostic report had to include evidence for morphological and cyclin D1 or t (11; 14).
  2. Eastern Cooperative Oncology Group performance status of 0-2.
  3. Measurable disease by computed tomography/magnetic resonance imaging.
  4. Received prior regimens for MCL.
  5. 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.
  6. Aspartate aminotransferase and alanine aminotransferase ≤ 2.5 x upper limit of normal (ULN).
  7. Total bilirubin ≤ 2 x ULN (unless documented Gilbert's syndrome).
  8. Life expectancy of > 4 months.

Key Exclusion Criteria:

  1. Current or history of central nervous system lymphoma.
  2. Prior exposure to a BTK inhibitor before enrollment.
  3. Prior corticosteroids with anti-neoplastic intent within 7 days.
  4. Major surgery within 4 weeks of screening.
  5. Toxicity must have recovered from prior chemotherapy.
  6. History of other active malignancies within 2 years of study entry.
  7. Currently clinically significant active cardiovascular disease.
  8. QT interval corrected with Fridericia's formula > 450 microseconds or other significant electrocardiogram abnormalities.
  9. Uncontrolled systemic infection or infection requiring parenteral anti-microbial therapy.
  10. 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.

Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Locations
Layout table for location information
China, Beijing
Beijing Cancer Hospital
Beijing, Beijing, China, 100142
Peking Union Medical College Hospital
Beijing, Beijing, China
China, Fujian
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
China, Guangdong
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, China
China, Henan
Henan Cancer Province
Zhengzhou, Henan, China
China, Hubei
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China
China, Jiangsu
Jiangsu Province Hospital
Nanjing, Jiangsu, China
China, Jilin
The First Affiliated Hospital of Jinlin University
Chang chun, Jilin, China
China, Shanghai
Fudan University Cancer Center
Shanghai, Shanghai, China
China, Sichuan
West China Hospital, Sichuan University
Chengdu, Sichuan, China
China, Tianjin
Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin, Tianjin, China
Tianjin Cancer Hospital
Tianjin, Tianjin, China
China, Zhejiang
The First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Sponsors and Collaborators
BeiGene
Investigators
Layout table for investigator information
Principal Investigator: Study Director BeiGene
  Study Documents (Full-Text)

Documents provided by BeiGene:
Study Protocol  [PDF] September 6, 2018
Statistical Analysis Plan  [PDF] April 2, 2018

More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications of Results:
Yuqin Song, Keshu Zhou, Dehui Zou, Jianfeng Zhou, Jianda Hu, Haiyan Yang, Huilai Zhang, Jie Ji, Wei Xu, Jie Jin, Fangfang Lv, Ru Feng, Sujun Gao, Daobin Zhou, Haiyi Guo, Aihua Wang, James Hilger, Jane Huang, William Novotny, Muhtar Osman, Jun Zhu; Safety and Activity of the Investigational Bruton Tyrosine Kinase Inhibitor Zanubrutinib (BGB-3111) in Patients with Mantle Cell Lymphoma from a Phase 2 Trial. Blood 2018; 132 (Supplement 1): 148. doi: https://doi.org/10.1182/blood-2018-99-117956

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: BeiGene
ClinicalTrials.gov Identifier: NCT03206970    
Other Study ID Numbers: BGB-3111-206
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

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Lymphoma
Lymphoma, Mantle-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
 Lymphoma, Non-Hodgkin
Zanubrutinib
Tyrosine Kinase Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents