Clinical Trials /

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

NCT03734016

Description:

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.

Related Conditions:
  • Chronic Lymphocytic Leukemia
  • Small Lymphocytic Lymphoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: BGB-3111-305
  • SECONDARY ID: 2018-001366-42
  • SECONDARY ID: CTR20190098
  • NCT ID: NCT03734016

Conditions

  • Chronic Lymphocytic Leukemia
  • Small Lymphocytic Lymphoma

Interventions

DrugSynonymsArms
BGB-3111ZanubrutinibZanubrutinib
IbrutinibImbruvicaIbrutinib

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions
ZanubrutinibExperimentalZanubrutinib (BGB-3111) will be orally administered until disease progression or unacceptable toxicity.
  • BGB-3111
IbrutinibActive ComparatorIbrutinib will be orally administered until disease progression or unacceptable toxicity.
  • Ibrutinib

Eligibility 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Overall response rate determined by independent central review
Time Frame:29 months
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Progression-free survival determined by independent central review
Time Frame:65 months
Safety Issue:
Description:
Measure:Progression-free survival determined by investigator assessment
Time Frame:65 months
Safety Issue:
Description:
Measure:Duration of response determined by independent central review
Time Frame:65 months
Safety Issue:
Description:
Measure:Duration of response determined by investigator assessment
Time Frame:65 months
Safety Issue:
Description:
Measure:Time to treatment failure
Time Frame:65 months
Safety Issue:
Description:
Measure:Overall survival
Time Frame:65 months
Safety Issue:
Description:
Measure:Patient reported outcomes as assessed by EORTC-QLQ-C30
Time Frame:65 months
Safety Issue:
Description:
Measure:Patient reported outcomes as assessed by EQ-5D-5L
Time Frame:65 months
Safety Issue:
Description:
Measure:Incidence of adverse events as assessed by CTCAE v4.03 [Safety and Tolerability]
Time Frame:80 months
Safety Issue:
Description:

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:BeiGene

Trial Keywords

  • Chronic Lymphocytic Leukemia
  • Small Lymphocytic Lymphoma
  • CLL
  • SLL
  • relapsed
  • refractory

Last Updated

November 1, 2019