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Treatment of CD79B Mutant Relapsed/Refractory Diffuse Large B-Cell Lymphoma With Bruton Tyrosine Kinase Inhibitor Zanubrutinib

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05068440
Recruitment Status : Recruiting
First Posted : October 5, 2021
Last Update Posted : February 16, 2023
Sponsor:
Information provided by (Responsible Party):
BeiGene

Study Description
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Brief Summary:
Study consists of a single arm to explore the efficacy and safety of zanubrutinib in participants with CD79B mutant Relapsed/Refractory Diffuse Large B-Cell Lymphoma.

Condition or disease Intervention/treatment Phase
Relapsed Diffuse Large B-cell Lymphoma Refractory Diffuse Large B-cell Lymphoma Drug: Zanubrutinib Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2, Single-Arm, Open-Label, Multicenter Study of the Bruton Tyrosine Kinase Inhibitor Zanubrutinib in Patients With CD79B Mutant Relapsed/Refractory Diffuse Large B-Cell Lymphoma
Actual Study Start Date : August 11, 2021
Estimated Primary Completion Date : June 30, 2024
Estimated Study Completion Date : December 30, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arms and Interventions
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Arm Intervention/treatment
Experimental: Zanubrutinib
administered orally
 Drug: Zanubrutinib
administered orally as capsules
Other Names:
  • BGB-3111
  • Brukinsa


Outcome Measures
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Primary Outcome Measures :
  1. Overall response rate (ORR) [ Time Frame: approximately 2 years ]
    Defined as the proportion of participants who achieved complete response (CR) or partial response (PR) by investigator assessment according to the Lugano classification for Non-Hodgkin's Lymphoma (NHL).


Secondary Outcome Measures :
  1. Overall response rate (ORR) [ Time Frame: approximately 3.5 years ]
    Defined as the proportion of participants who achieved complete response (CR) or partial response (PR) by Independent Review Committee assessment according to the Lugano classification for Non-Hodgkin's Lymphoma (NHL).

  2. Complete response rate (CRR) [ Time Frame: approximately 3.5 years ]
    Defined as the proportion of participants with a documented CR determined by the Independent Review Committee and by investigator assessment

  3. Duration of response (DOR) [ Time Frame: approximately 3.5 years ]
    DOR is defined as the time from the date of the first documented response (PR or better) after treatment initiation until the date of first documented disease progression or death, whichever occurs first. Determined by the Independent Review Committee and by investigator assessment

  4. Progression-free survival (PFS) [ Time Frame: approximately 3.5 years ]
    PFS is defined as time from start of treatment to the first documentation of disease progression or death, whichever occurs first as determined by the Independent Review Committee and by investigator assessment

  5. Time to response (TTR) [ Time Frame: approximately 3.5 years ]
    TTR is defined as the time from start of treatment to first documentation of response of Partial Response (PR) or better as determined by the Independent Review Committee and by investigator assessment

  6. Overall survival (OS) [ Time Frame: approximately 3.5 years ]
    OS defined as the time from start of treatment to the date of death due to any cause

  7. Number of participants with adverse events [ Time Frame: approximately 3.5 years ]
    Number of participants with adverse events and serious adverse events, including clinical laboratory measurements, physical examination, and vital signs


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histologically confirmed DLBCL based on the World Health Organization (WHO) 2008 classification of tumors of hematopoietic and lymphoid tissue.
  2. Positive CD79B mutation confirmed by the central laboratory.
  3. Previously received at least 1 line of adequate systemic anti-DLBCL therapy, defined as an anti-CD20 antibody-based chemoimmunotherapy for at least 2 consecutive cycles, unless participants had disease progression before Cycle 2

  4. Relapsed or refractory (R/R) disease before study entry, defined as either

    1. Recurrent disease after having achieved disease remission (CR or partial response [PR]) at the completion of the latest treatment regimen.
    2. Stable disease or PD at the completion of the latest treatment regimen

  5. Ineligible for high dose therapy/stem cell transplantation, which is defined as meeting any of the following criteria:

    1. Significant organ dysfunction (eg, left ventricular ejection fraction < 50% by echocardiogram or multiple gated acquisition scan [MUGA], diffuse lung capacity for carbon monoxide < 60% predicted by pulmonary function test, creatinine clearance < 70 mL/min shown by nuclear medicine scan or 24-hour urine collection) or comorbidities precluding the use of high dose therapy/stem cell transplantation on the basis of unacceptable risk of treatment-related morbidity
    2. Failure to achieve CR or PR with salvage therapy.
    3. Failure to collect stem cells or unable to perform stem cell collection as assessed by the investigator.

Exclusion Criteria:

  1. Participants who have NHL other than classical histology DLBCL (DLBCL, not otherwise specified), eg, participants with DLBCL transformed from indolent lymphomas, primary mediastinal (thymic) large B-cell lymphoma, primary cutaneous DLBCL, primary effusion lymphoma, and central nervous system (CNS) lymphoma.
  2. History of allogeneic stem cell transplantation or chimeric antigen receptor (CAR) T-cell therapy.
  3. Prior exposure to a Bruton's tyrosine kinase (BTK) inhibitor.

  4. Receipt of the following treatment at the time indicated before the first dose of study drug:

    1. Corticosteroid given with antineoplastic intent within 2 weeks, but a short course (≤ 7 days) of systemic corticosteroid treatment at doses ≤ 20 mg/day prednisone equivalent for control of lymphoma-related symptoms is allowed prior to enrollment provided that it is tapered off within 5 days after initiation of study treatment.
    2. Chemotherapy or radiotherapy within 2 weeks.
    3. Monoclonal antibody within 2 weeks.
    4. Investigational therapy within 2 weeks.
    5. Chinese patent medicine with antineoplastic intent within 2 weeks.
  5. History of other active malignancies within 2 years before study entry, with the exception of (1) adequately treated in-situ carcinoma of the cervix; (2) localized basal cell or squamous cell carcinoma of the skin; (3) previous malignancy confined and treated locally (surgery or other modality) with curative intent.

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

Contacts and Locations
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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): NCT05068440


Contacts
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Contact: BeiGene 1.877.828.5568 clinicaltrials@beigene.com

Locations
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Sponsors and Collaborators
BeiGene
Investigators
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Study Director: Study Director BeiGene
More Information
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Responsible Party: BeiGene
ClinicalTrials.gov Identifier: NCT05068440    
Other Study ID Numbers: BGB-3111-218
CTR20210786 ( Registry Identifier: ChinaDrugTrials )
First Posted: October 5, 2021    Key Record Dates
Last Update Posted: February 16, 2023
Last Verified: February 2023
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
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
 Immune System Diseases
Lymphoma, Non-Hodgkin
Zanubrutinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action