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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03734016
Recruitment Status : Active, not recruiting
First Posted : November 7, 2018
Last Update Posted : December 6, 2021
Sponsor:
Information provided by (Responsible Party):
BeiGene

Study Description
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Brief Summary:
This study is designed to compare the overall response rate of zanubrutinib versus ibrutinib in participants with relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma.

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

Detailed Description:

This is a global, Phase 3, randomized study of zanubrutinib versus ibrutinib in approximately 600 participants with relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 652 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 1, 2018
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : August 2023

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


Outcome Measures
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Primary Outcome Measures :
  1. Overall response rate determined by investigator assessment [ Time Frame: Up to 50 months ]

Secondary Outcome Measures :
  1. Progression-free survival determined by independent central review [ Time Frame: Up to 50 months ]
  2. Progression-free survival determined by investigator assessment [ Time Frame: Up to 51 months ]
  3. Duration of response determined by investigator assessment [ Time Frame: Up to 51 months ]
  4. Duration of response determined by independent central review [ Time Frame: Up to 51 months ]
  5. Time to treatment failure [ Time Frame: Up to 51 months ]
  6. Overall survival [ Time Frame: Up to 51 months ]
  7. Patient reported outcomes as assessed by EORTC-QLQ-C30 [ Time Frame: Up to 51 months ]
  8. Patient reported outcomes as assessed by EQ-5D-5L [ Time Frame: Up to 51 months ]
  9. Incidence of adverse events as assessed by CTCAE v4.03 [Safety and Tolerability] [ Time Frame: 51 months ]
  10. Rate of partial response with lymphocytosis (PR-L) or higher determined by independent central review [ Time Frame: Up to 51 months ]
    Proportion of participants who achieve a CR/CRi + PR + nodular PR + PR-L

  11. Overall response rate determined by independent central review [ Time Frame: 51 months ]

Other Outcome Measures:
  1. Correlation between prognostic and predictive biomarkers and clinical outcomes [ Time Frame: Up to 51 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. Confirmed diagnosis of CLL or SLL that meets the 2008 IWCLL criteria
  2. CLL/SLL requiring treatment per 2008 IWCLL criteria
  3. Relapsed or refractory to at least 1 prior systemic therapy for CLL/SLL
  4. Measurable disease by CT/magnetic resonance imaging (MRI)
  5. ECOG performance status of 0, 1, or 2
  6. Life expectancy ≥ 6 months
  7. Adequate bone marrow function
  8. Adequate renal and hepatic function

Key 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, non-muscle-invasive bladder cancer, 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

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): NCT03734016


Locations
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Sponsors and Collaborators
BeiGene
Investigators
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Study Director: Tommi Salmi, MD BeiGene
More Information
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Publications of Results:

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Responsible Party: BeiGene
ClinicalTrials.gov Identifier: NCT03734016    
Other Study ID Numbers: BGB-3111-305
2018-001366-42 ( EudraCT Number )
CTR20190098 ( Registry Identifier: Center for drug evaluation, CFDA )
First Posted: November 7, 2018    Key Record Dates
Last Update Posted: December 6, 2021
Last Verified: December 2021
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:
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