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A Study of Zanubrutinib (BGB-3111) Versus Ibrutinib in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia

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ClinicalTrials.gov Identifier: NCT03734016
Recruitment Status : Recruiting
First Posted : November 7, 2018
Last Update Posted : April 9, 2019
Sponsor:
Information provided by (Responsible Party):
BeiGene

Tracking Information
First Submitted Date  ICMJE November 2, 2018
First Posted Date  ICMJE November 7, 2018
Last Update Posted Date April 9, 2019
Actual Study Start Date  ICMJE November 5, 2018
Estimated Primary Completion Date February 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 6, 2018)
Overall response rate determined by independent central review [ Time Frame: 29 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03734016 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 6, 2018)
  • Progression-free survival determined by independent central review [ Time Frame: 65 months ]
  • Progression-free survival determined by investigator assessment [ Time Frame: 65 months ]
  • Duration of response determined by independent central review [ Time Frame: 65 months ]
  • Duration of response determined by investigator assessment [ Time Frame: 65 months ]
  • Time to treatment failure [ Time Frame: 65 months ]
  • Overall survival [ Time Frame: 65 months ]
  • Patient reported outcomes as assessed by EORTC-QLQ-C30 [ Time Frame: 65 months ]
  • Patient reported outcomes as assessed by EQ-5D-5L [ Time Frame: 65 months ]
  • Incidence of adverse events as assessed by CTCAE v4.03 [Safety and Tolerability] [ Time Frame: 80 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: November 6, 2018)
Correlation between prognostic and predictive biomarkers and clinical outcomes [ Time Frame: 65 months ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE A Study of Zanubrutinib (BGB-3111) Versus Ibrutinib in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia
Official Title  ICMJE A Phase 3, Randomized Study of Zanubrutinib (BGB-3111) Compared With Ibrutinib in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Brief Summary This study is designed to compare the overall response rate of zanubrutinib versus ibrutinib in patients with relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma.
Detailed Description

This is a global, Phase 3, randomized study of zanubrutinib versus ibrutinib in approximately 400 patients with relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma.

The primary efficacy endpoint is overall response rate determined by independent central review. Patients will be randomized in a 1:1 manner to either zanubrutinib or ibrutinib. Treatment with zanubrutinib and ibrutinib will be open label.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Chronic Lymphocytic Leukemia
  • Small Lymphocytic Lymphoma
Intervention  ICMJE
  • Drug: BGB-3111
    160 mg orally twice daily
    Other Name: Zanubrutinib
  • Drug: Ibrutinib
    Ibrutinib 420 mg orally once daily
    Other Name: Imbruvica
Study Arms  ICMJE
  • Experimental: Zanubrutinib
    Zanubrutinib (BGB-3111) will be orally administered until disease progression or unacceptable toxicity.
    Intervention: Drug: BGB-3111
  • Active Comparator: Ibrutinib
    Ibrutinib will be orally administered until disease progression or unacceptable toxicity.
    Intervention: Drug: Ibrutinib
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: November 6, 2018)
400
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2025
Estimated Primary Completion Date February 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria

  1. Age 18 years or older
  2. Confirmed diagnosis of CLL or SLL that meets the 2008 IWCLL criteria
  3. CLL/SLL requiring treatment per 2008 IWCLL criteria
  4. Relapsed or refractory to at least 1 prior systemic therapy for CLL/SLL
  5. Measurable disease by CT/magnetic resonance imaging (MRI)
  6. ECOG performance status of 0, 1, or 2
  7. Life expectancy ≥ 6 months
  8. Adequate bone marrow function
  9. Adequate renal and hepatic function

Exclusion Criteria

  1. Known prolymphocytic leukemia or history of, or currently suspected, Richter's transformation
  2. Clinically significant cardiovascular disease.
  3. Prior malignancy within the past 3 years, except for curatively treated basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast
  4. History of severe bleeding disorder or history of spontaneous bleeding requiring blood transfusion or other medical intervention
  5. History of stroke or intracranial hemorrhage within 180 days before first dose of study drug
  6. Severe or debilitating pulmonary disease
  7. Active fungal, bacterial, and/or viral infection requiring systemic therapy
  8. Known central nervous system involvement by leukemia or lymphoma
  9. Known infection with HIV or active viral hepatitis B or C infection
  10. Moderate or severe hepatic impairment, ie, Child-Pugh class B or C
  11. Major surgery within 4 weeks of the first dose of study drug
  12. Prior treatment with a BTK inhibitor
  13. Toxicity from prior anticancer therapy that has not recovered to ≤ Grade 1
  14. Pregnant or lactating women
  15. Vaccination with a live vaccine within 35 days prior to the first dose of study drug
  16. Hypersensitivity to zanubrutinib, ibrutinib, or any of the other ingredients in either drug
  17. Concurrent participation in another therapeutic clinical trial
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: Jason Paik, MD, PhD 1-877-828-5568 clinicaltrials@beigene.com
Contact: James Hilger, PhD 1-877-828-5568 clinicaltrials@beigene.com
Listed Location Countries  ICMJE Australia,   China,   France,   New Zealand,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03734016
Other Study ID Numbers  ICMJE BGB-3111-305 (ALPINE)
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: No
Responsible Party BeiGene
Study Sponsor  ICMJE BeiGene
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account BeiGene
Verification Date April 2019

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