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Zanubrutinib (BGB-3111) in Participants With Previously Treated B-Cell Lymphoma Intolerant of Prior Bruton Tyrosine Kinase Inhibitor (BTKi) Treatment

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ClinicalTrials.gov Identifier: NCT04116437
Recruitment Status : Recruiting
First Posted : October 4, 2019
Last Update Posted : April 25, 2024
Sponsor:
Information provided by (Responsible Party):
BeiGene

Study Description
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Brief Summary:
The primary objective of this study is to evaluate the safety of zanubrutinib (also known as BGB-3111) in chronic lymphocytic leukemia/small lymphocytic lymphoma, Waldenström macroglobulinemia, mantle cell lymphoma, or marginal zone lymphoma patients who have become intolerant of prior ibrutinib and/or acalabrutinib treatment, by comparing intolerance to adverse event profile as assessed by the recurrence and the change in severity of adverse events.

Condition or disease Intervention/treatment Phase
Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Mantle Cell Lymphoma Marginal Zone Lymphoma Waldenstrom Macroglobulinemia Drug: Zanubrutinib Phase 2

Expanded Access : An investigational treatment associated with this study is no longer available outside the clinical trial.   More info ...

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2, Multicenter, Single-arm Study of Zanubrutinib (BGB-3111) in Patients With Previously Treated B-Cell Lymphoma Intolerant of Prior Treatment With Ibrutinib and/or Acalabrutinib
Actual Study Start Date : October 15, 2019
Estimated Primary Completion Date : October 2025
Estimated Study Completion Date : October 2025

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

Cohort 1: Chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL), Waldenström macroglobulinemia (WM), mantle cell lymphoma (MCL), or marginal zone lymphoma (MZL) previously treated with ibrutinib

Cohort 2: Chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL), Waldenström macroglobulinemia (WM), mantle cell lymphoma (MCL), or marginal zone lymphoma (MZL) previously treated with acalabrutinib alone/with ibrutinib

 Drug: Zanubrutinib
Zanubrutinib (BGB-3111) will be orally administered at a dose of 160 mg twice daily or 320mg once daily until disease progression, unacceptable toxicity, treatment consent withdrawal, or study termination.
Other Names:
  • BGB-3111
  • BRUKINSA


Outcome Measures
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Primary Outcome Measures :
  1. Recurrence and change in severity of treatment-emergent Adverse Events (AEs) of interest. [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. Overall response as determined by investigator [ Time Frame: 24 months ]
  2. Progression free survival (PFS) as determined by investigator [ Time Frame: 24 months ]
  3. Patient reported outcomes as measured by EuroQol five dimension scale (EQ-5D) [ Time Frame: 24 months ]
  4. Patient reported outcomes as measured by European Organisation for Research and Treatment of Cancer (EORTC) [ Time Frame: 24 months ]
  5. Disease control rate as determined by investigator [ Time Frame: 24 months ]

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

Key Inclusion Criteria:

  1. Participants must meet protocol defined disease criteria requiring treatment for their respective disease prior to initiation of ibrutinib or acalabrutinib

  2. Ibrutinib and acalabrutinib intolerance is defined as an unacceptable toxicity where, in the opinion of the investigator, treatment should be discontinued in spite of optimal supportive care as a result of one of the following:

    1. For ibrutinib and acalabrutinib intolerance events:

      • 1 or more ≥ Grade 2 nonhematologic toxicities for >7 days (with or without treatment)
      • 1 or more ≥ Grade 3 nonhematologic toxicity of any duration
      • 1 or more Grade 3 neutropenia with infection or fever of any duration; or
      • Grade 4 heme toxicity which persists to the point that the investigator chose to stop therapy due to toxicity NOT progression.

    2. For acalabrutinib intolerance events only;

      • 1 or more ≥ Grade 1 nonhematologic toxicities of any duration with > 3 recurrent episodes; or
      • 1 or more ≥ Grade 1 nonhematologic toxicities for > 7 days (with or without treatment); or
      • Inability to use acid-reducing agents or anticoagulants (eg, proton pump inhibitors, warfarin) due to concurrent acalabrutinib use
  3. Ibrutinib and/or acalabrutinib-related ≥ Grade 2 toxicities must have resolved to ≤ Grade 1 or baseline prior to initiating treatment with zanubrutinib. Grade 1 acalabrutinib-related toxicities must have resolved to Grade 0 or baseline prior to initiating treatment with zanubrutinib.
  4. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
  5. Absolute neutrophil count (ANC) ≥ 1000/mm^3 with or without growth factor support and platelet count ≥ 50,000/mm^3 (may be post-transfusion), on or prior to C1D1 of zanubrutinib

Key Exclusion Criteria:

  1. Clinically significant cardiovascular disease including the following:

    1. Myocardial infarction within 6 months before the Screening
    2. Unstable angina within 3 months before the Screening
    3. New York Heart Association class III or IV congestive heart failure
    4. History of sustained ventricular tachycardia, ventricular fibrillation, and/or Torsades de Pointes
    5. QT interval corrected by Fridericia's formula > 480 milliseconds
    6. History of Mobitz II second-degree or third-degree heart block without a permanent pacemaker in place
  2. History of central nervous system (CNS) hemorrhage
  3. Documented progressive disease (PD) during ibrutinib and/or acalabrutinib treatment.
  4. Have received any anticancer therapy (other than immunotherapy) for CLL/SLL, WM, MCL, and MZL < 7 days before any Screening assessments are performed or any immunotherapy treatment, taken alone or as part of a chemoimmunotherapy regimen, < 4 weeks before any Screening assessments are performed
  5. Requires ongoing need for corticosteroid treatment > 10 mg daily of prednisone or equivalent corticosteroid. Note: Systemic corticosteroids must be fully tapered off/discontinued ≥ 5 days before the first dose of study drug is administered.

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): NCT04116437


Contacts
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Contact: BeiGene 1-877-828-5568 clinicaltrials@beigene.com

Locations
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Sponsors and Collaborators
BeiGene
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: BeiGene
ClinicalTrials.gov Identifier: NCT04116437    
Other Study ID Numbers: BGB-3111-215
First Posted: October 4, 2019    Key Record Dates
Last Update Posted: April 25, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by BeiGene:
BGB-3111
Zanubrutinib
Ibrutinib Intolerance
BTK Inhibitor
Acalabrutinib Intolerance
Additional relevant MeSH terms:
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Lymphoma
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, Mantle-Cell
Waldenstrom Macroglobulinemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Leukemia, Lymphoid
Leukemia
Hematologic Diseases
Leukemia, B-Cell
 Chronic Disease
Disease Attributes
Pathologic Processes
Neoplasms, Plasma Cell
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hemorrhagic Disorders
Zanubrutinib
Tyrosine Kinase Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action