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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

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.

Condition or disease Intervention/treatment Phase
Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma Drug: BGB-3111 Drug: Ibrutinib Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized Study of Zanubrutinib (BGB-3111) Compared With Ibrutinib in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Actual Study Start Date : November 5, 2018
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : October 2025


Arm Intervention/treatment
Experimental: Zanubrutinib
Zanubrutinib (BGB-3111) will be orally administered until disease progression or unacceptable toxicity.
Drug: BGB-3111
160 mg orally twice daily
Other Name: Zanubrutinib

Active Comparator: Ibrutinib
Ibrutinib will be orally administered until disease progression or unacceptable toxicity.
Drug: Ibrutinib
Ibrutinib 420 mg orally once daily
Other Name: Imbruvica




Primary Outcome Measures :
  1. Overall response rate determined by independent central review [ Time Frame: 29 months ]

Secondary Outcome Measures :
  1. Progression-free survival determined by independent central review [ Time Frame: 65 months ]
  2. Progression-free survival determined by investigator assessment [ Time Frame: 65 months ]
  3. Duration of response determined by independent central review [ Time Frame: 65 months ]
  4. Duration of response determined by investigator assessment [ Time Frame: 65 months ]
  5. Time to treatment failure [ Time Frame: 65 months ]
  6. Overall survival [ Time Frame: 65 months ]
  7. Patient reported outcomes as assessed by EORTC-QLQ-C30 [ Time Frame: 65 months ]
  8. Patient reported outcomes as assessed by EQ-5D-5L [ Time Frame: 65 months ]
  9. Incidence of adverse events as assessed by CTCAE v4.03 [Safety and Tolerability] [ Time Frame: 80 months ]

Other Outcome Measures:
  1. Correlation between prognostic and predictive biomarkers and clinical outcomes [ Time Frame: 65 months ]


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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. 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

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): NCT03734016


Contacts
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Contact: Jason Paik, MD, PhD 1-877-828-5568 clinicaltrials@beigene.com
Contact: James Hilger, PhD 1-877-828-5568 clinicaltrials@beigene.com

Locations
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United States, Nevada
Comprehensive Cancer Centers of Nevada - USOR Recruiting
Las Vegas, Nevada, United States, 89169
Principal Investigator: Edwin Kingsley, MD         
United States, New Jersey
New Jersey Hematology Oncology Associates LLC Recruiting
Brick, New Jersey, United States, 08724
Principal Investigator: Apurv Agrawal, MD         
Summit Medical Group Recruiting
Florham Park, New Jersey, United States, 07932
Principal Investigator: Benjamin Freeman, MD         
United States, New York
Clinical Research Alliance Inc Recruiting
Lake Success, New York, United States, 11042
Principal Investigator: Morton Coleman, MD         
United States, Texas
Joe Arrington Cancer Research and Treatment Center Recruiting
Lubbock, Texas, United States, 79410
Principal Investigator: Donald Quick, MD         
United States, Virginia
Oncology and Hematology Associates of Southwest Virginia Inc Recruiting
Roanoke, Virginia, United States, 24014
Principal Investigator: Amanda Twardy, MD         
United States, Washington
VA Puget Sound Health Care System - NAVREF Recruiting
Seattle, Washington, United States, 98108
Principal Investigator: Solomon Graf, MD         
Seattle Cancer Care Alliance Recruiting
Seattle, Washington, United States, 98109
Principal Investigator: Mazyar Shadman, MD         
Medical Oncology Associates Recruiting
Spokane, Washington, United States, 99208
Principal Investigator: Arvind Chaudhry         
Australia
Peninsula Private Hospital Recruiting
Frankston, Australia, 3199
Principal Investigator: Patricia Walker, MD         
Adelaide Cancer Centre Recruiting
Kurralta Park, Australia, 5037
Principal Investigator: Nicholas Wickham, MD         
Icon Cancer Foundation Recruiting
Milton, Australia, 4066
Principal Investigator: Matthew Hourigan, MD         
China
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences Recruiting
Tianjin, China, 300052
Principal Investigator: Lugui QIU, MD         
Henan Cancer Hospital Recruiting
Zhengzhou, China, 450046
Principal Investigator: Keshu ZHOU, MD         
France
Centre Hospitalier Lyon Sud Recruiting
Pierre Benite, France, 69495
Principal Investigator: Emmanuelle Ferrant, MD         
New Zealand
Wellington Hospital Recruiting
Newtown, New Zealand, 6021
Principal Investigator: Robert Weinkove, MD         
Tauranga Hospital Recruiting
Tauranga, New Zealand, 3143
Principal Investigator: Gillian Corbett, MD         
United Kingdom
Kent and Canterbury Hospital Recruiting
Canterbury, United Kingdom, CT1 3NG
Principal Investigator: Moya Young, MD         
Sponsors and Collaborators
BeiGene

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Responsible Party: BeiGene
ClinicalTrials.gov Identifier: NCT03734016     History of Changes
Other Study ID Numbers: BGB-3111-305 (ALPINE)
First Posted: November 7, 2018    Key Record Dates
Last Update Posted: April 9, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma
CLL
SLL
relapsed
refractory

Additional relevant MeSH terms:
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Lymphoma
Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Zanubrutinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action