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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 20, 2021
Sponsor:
Information provided by (Responsible Party):
BeiGene

Tracking Information
First Submitted Date  ICMJE October 1, 2019
First Posted Date  ICMJE October 4, 2019
Last Update Posted Date April 20, 2021
Actual Study Start Date  ICMJE October 15, 2019
Estimated Primary Completion Date June 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 18, 2020)
Recurrence and change in severity of treatment-emergent Adverse Events (AEs) of interest. [ Time Frame: 24 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 2, 2019)
Frequency and severity of treatment-emergent AEs of interest. [ Time Frame: 24 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 19, 2021)
  • Overall response as determined by investigator [ Time Frame: 24 months ]
  • Progression free survival (PFS) as determined by investigator [ Time Frame: 24 months ]
  • Patient reported outcomes as measured by EuroQol five dimension scale (EQ-5D) [ Time Frame: 24 months ]
  • Patient reported outcomes as measured by European Organisation for Research and Treatment of Cancer (EORTC) [ Time Frame: 24 months ]
  • Disease control rate as determined by investigator [ Time Frame: 24 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 2, 2019)
  • Overall response as determined by investigator. [ Time Frame: 24 months ]
  • Progression free survival as determined by investigator [ Time Frame: 24 months ]
  • Patient reported outcomes as measured by EQ-5D. [ Time Frame: 24 months ]
  • Patient reported outcomes as measured by EORTC. [ Time Frame: 24 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures
 (submitted: October 2, 2019)
  • Change in number of steps taken during a 6 minute walk test measured by a smart device. [ Time Frame: 24 months ]
  • Change in number of daily steps taken measured by a smart device. [ Time Frame: 24 months ]
  • Change in quality of life measured by a questionnaire taken on a smart device. [ Time Frame: 24 months ]
 
Descriptive Information
Brief Title  ICMJE Zanubrutinib (BGB-3111) in Participants With Previously Treated B-Cell Lymphoma Intolerant of Prior Bruton Tyrosine Kinase Inhibitor (BTKi) Treatment
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
  • Mantle Cell Lymphoma
  • Marginal Zone Lymphoma
  • Waldenstrom Macroglobulinemia
Intervention  ICMJE 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
Study Arms  ICMJE 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

Intervention: Drug: Zanubrutinib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 19, 2021)
90
Original Estimated Enrollment  ICMJE
 (submitted: October 2, 2019)
60
Estimated Study Completion Date  ICMJE July 2025
Estimated Primary Completion Date June 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: BeiGene 1-877-828-5568 clinicaltrials@beigene.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04116437
Other Study ID Numbers  ICMJE BGB-3111-215
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party BeiGene
Study Sponsor  ICMJE BeiGene
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Dih-Yih Chen, MD BeiGene
PRS Account BeiGene
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP