Clinical Trials /

Zanubrutinib (BGB-3111) in Participants With Previously Treated B-Cell Lymphoma Intolerant of Prior Bruton Tyrosine Kinase Inhibitor (BTKi) Treatment

NCT04116437

Description:

The primary objective of this study is to evaluate the safety of zanubrutinib (also known as BGB-3111) in participants with previously treated chronic lymphocytic leukemia/small lymphocytic lymphoma, Waldenström macroglobulinemia, mantle cell lymphoma, or marginal zone lymphoma intolerant of prior ibrutinib and/or acalabrutinib treatment, compared with their ibrutinib and/or acalabrutinib intolerance adverse event profile as assessed by the recurrence and the change in severity of adverse events.

Related Conditions:
  • Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
  • Mantle Cell Lymphoma
  • Marginal Zone Lymphoma
  • Waldenstrom Macroglobulinemia
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Zanubrutinib (BGB-3111) in Participants With Previously Treated B-Cell Lymphoma Intolerant of Prior Bruton Tyrosine Kinase Inhibitor (BTKi) Treatment
  • Official Title: 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

Clinical Trial IDs

  • ORG STUDY ID: BGB-3111-215
  • NCT ID: NCT04116437

Conditions

  • Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
  • Mantle Cell Lymphoma
  • Marginal Zone Lymphoma
  • Waldenstrom Macroglobulinemia

Interventions

DrugSynonymsArms
ZanubrutinibBGB-3111Zanubrutinib

Purpose

The primary objective of this study is to evaluate the safety of zanubrutinib (also known as BGB-3111) in participants with previously treated chronic lymphocytic leukemia/small lymphocytic lymphoma, Waldenström macroglobulinemia, mantle cell lymphoma, or marginal zone lymphoma intolerant of prior ibrutinib and/or acalabrutinib treatment, compared with their ibrutinib and/or acalabrutinib intolerance adverse event profile as assessed by the recurrence and the change in severity of adverse events.

Trial Arms

NameTypeDescriptionInterventions
ZanubrutinibExperimentalPreviously Treated chronic lymphocytic leukemia (CLL)/ Small Lymphocytic Lymphoma (SLL), Waldenstrom Macroglobulinemia (WM), Mantle Cell Lymphoma (MCL), or Marginal Zone Lymphoma (MZL)
  • Zanubrutinib

Eligibility Criteria

        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. Ibrutininb and/or acalabrutinib intolerance 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. 1 or more Grade ≥2 non-hematological toxicities for >7 days (with or without
                  treatment)

               2. 1 or more Grade ≥3 non-hematological toxicity of any duration

               3. 1 or more Grade 3 neutropenia with infection or fever or

               4. Grade 4 heme toxicity which persists to the point that the investigator chose to
                  stop therapy due to toxicity NOT progression.

          3. Ibrutinib and/or acalabrutinib-related toxicities must have resolved to Grade ≤ 1 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/mm3 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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Recurrence and change in severity of treatment-emergent Adverse Events (AEs) of interest.
Time Frame:24 months
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Overall response as determined by investigator
Time Frame:24 months
Safety Issue:
Description:
Measure:Progression free survival (PFS) as determined by investigator
Time Frame:24 months
Safety Issue:
Description:
Measure:Patient reported outcomes as measured by EuroQol five dimension scale (EQ-5D)
Time Frame:24 months
Safety Issue:
Description:
Measure:Patient reported outcomes as measured by European Organisation for Research and Treatment of Cancer (EORTC)
Time Frame:24 months
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:BeiGene

Trial Keywords

  • BGB-3111
  • Zanubrutinib
  • Ibrutinib/acalabrutinib Intolerance
  • BTK Inhibitor

Last Updated

May 18, 2020