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Study of 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. Identifier: NCT03206970
Recruitment Status : Completed
First Posted : July 2, 2017
Results First Posted : May 13, 2020
Last Update Posted : January 6, 2021
Information provided by (Responsible Party):

Brief Summary:
The primary objective of this study is 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

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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 Refractory or Relapsed 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

Arm Intervention/treatment
Experimental: zanubrutinib
160 mg administered orally twice daily (BID) for up to 3 years
Drug: zanubrutinib
Administered as specified in the treatment arm
Other Name: BGB-3111

Primary Outcome Measures :
  1. Overall Response Rate (ORR) as Assessed by Independent Review Committee [ Time Frame: Up to 2 years ]
    ORR is assessed in accordance with the 2014 modification of the International Working Group on non-Hodgkin Lymphoma Criteria.

Secondary Outcome Measures :
  1. Overall Response Rate (ORR) as Assessed by the Investigator [ Time Frame: Up to 3 years ]
  2. Progression Free Survival (PFS) [ Time Frame: Up to 3 years ]
  3. Duration of Response (DOR) [ Time Frame: Up to 3 years ]
  4. Time to Response (TTR) [ Time Frame: Up to 3 years ]
  5. Number of Participants Experiencing Adverse Events (AEs) [ Time Frame: Up to 3 years ]
  6. Number of Participants Experiencing Serious Adverse Events (SAEs) [ Time Frame: Up to 3 years ]
  7. Number of Participants Experiencing Adverse Events (AEs) Leading to Treatment Disclontinuation [ Time Frame: Up to 3 years ]

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.

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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:

  1. Diagnostic report has to include evidence for morphological and cyclin D1 or t (11; 14).
  2. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
  3. Measurable disease by computed tomography/magnetic resonance imaging (CT/MRI).
  4. Received prior regimens for MCL.
  5. Documented failure to achieve any response, [stable disease (SD) or progressive disease during treatment] or documented progressive disease after response to the most recent treatment regimen.
  6. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 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 (CNS) 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 recover from prior chemotherapy.
  6. History of other active malignancies within 2 years of study entry.
  7. Currently clinically significant active cardiovascular disease.
  8. QTcF > 450 msecs or other significant ECG abnormalities.
  9. Uncontrolled systemic infection or infection requiring parenteral anti-microbial therapy.
  10. Known human immunodeficiency virus (HIV) infection, or active hepatitis B or hepatitis C infection (detected positive by polymerase chain reaction [PCR]).

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

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 identifier (NCT number): NCT03206970

Show Show 17 study locations
Sponsors and Collaborators
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Principal Investigator: Jun Zhu, PhD Lymphoma Department of Beijing University Cancer Hospital
  Study Documents (Full-Text)

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

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:

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Responsible Party: BeiGene 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: January 6, 2021
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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