Clinical Trials /

Study of Zanubrutinib in Japanese Participants With B-Cell Malignancies

NCT04172246

Description:

This is a Phase 1/2 study of zanubrutinib in Japanese participants with mature B-cell malignancies. This study intends to assess the use of zanubrutinib as an investigational agent to develop new treatment options for Japanese participants with B-cell malignancies. No formal hypothesis testing will be performed given the small sample size.

Related Conditions:
  • Mature B-Cell Neoplasm
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Study of Zanubrutinib in Japanese Participants With B-Cell Malignancies
  • Official Title: A Phase 1/2 Study of Zanubrutinib in Japanese Patients With Mature B-Cell Malignancies

Clinical Trial IDs

  • ORG STUDY ID: BGB-3111-111
  • SECONDARY ID: JapicCTI-195047
  • NCT ID: NCT04172246

Conditions

  • Mature B-cell Malignancies

Interventions

DrugSynonymsArms
ZanubrutinibBGB-3111Zanubrutinib

Purpose

This is a Phase 1/2 study of zanubrutinib in Japanese participants with mature B-cell malignancies. This study intends to assess the use of zanubrutinib as an investigational agent to develop new treatment options for Japanese participants with B-cell malignancies. No formal hypothesis testing will be performed given the small sample size.

Trial Arms

NameTypeDescriptionInterventions
ZanubrutinibExperimental
  • Zanubrutinib

Eligibility Criteria

        Key Inclusion Criteria:

          -  Participants with Confirmed diagnosis of mature B-cell neoplasms including chronic
             lymphocytic leukemia/ small lymphocytic lymphoma, mantle cell lymphoma, follicular
             lymphoma, marginal zone lymphoma and Waldenström's macroglobulinemia

          -  Relapsed/refractory disease defined as disease that relapsed after, or been refractory
             to, at least 1 prior therapy

          -  Meeting at least one of criteria for requiring treatment

          -  Measurable disease by computed tomography (CT)/ magnetic resonance imaging (MRI) for
             mantle cell lymphoma (MCL), marginal zone lymphoma (MZL) and follicular lymphoma (FL)
             participants and by serum immunoglobulin (Ig) M level > 0.5 g/dL for WM participants

          -  Eastern Cooperative Oncology Group performance status of 0, 1, or 2

          -  Life expectancy of > 4 months

        Key Exclusion Criteria:

          -  Known central nervous system involvement by lymphoma/leukemia

          -  Known plasma cell neoplasm, prolymphocytic leukemia, history of or currently suspected
             Richter's syndrome

          -  Prior allogeneic stem cell transplant

          -  Systemic chemotherapy or radiation therapy within 2 weeks prior to first dose of
             zanubrutinib

          -  Active fungal, bacterial, and/or viral infection requiring systemic therapy

          -  Prior therapy with B-cell receptor inhibitor (eg, Bruton tyrosine kinase,
             phosphoinositide 3 kinase delta, and/or spleen tyrosine kinase inhibitor) or B-cell
             lymphoma 2 inhibitor (eg, venetoclax/ABT-199)

          -  Pregnant, lactating, or nursing women

          -  Autoimmune anemia and/or thrombocytopenia that is poorly responsive to corticosteroids
             or other standard therapy

        NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:20 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Part 1: Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)
Time Frame:Until approximately 6 months after the last dose of zanubrutinib for the last participant who discontinues zanubrutinib or zanubrutinib becomes commercially available for the participant's disease, whichever is earlier
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Part 1: Bruton tyrosine kinase (BTK) occupancy in peripheral blood mononuclear cells
Time Frame:Predose up to 24 hours postdose
Safety Issue:
Description:
Measure:Part 1: Overall response rate (ORR) as assessed by the investigator
Time Frame:Until approximately 6 months after the last dose of zanubrutinib for the last participant who discontinues zanubrutinib or zanubrutinib becomes commercially available for the participant's disease, whichever is earlier
Safety Issue:
Description:
Measure:Part 1: Progression-free survival (PFS) as assessed by the investigator
Time Frame:Until approximately 6 months after the last dose of zanubrutinib for the last participant who discontinues zanubrutinib or zanubrutinib becomes commercially available for the participant's disease, whichever is earlier
Safety Issue:
Description:
Measure:Part 1: Duration of response as assessed by the investigator
Time Frame:Until approximately 6 months after the last dose of zanubrutinib for the last participant who discontinues zanubrutinib or zanubrutinib becomes commercially available for the participant's disease, whichever is earlier
Safety Issue:
Description:
Measure:Part 1: Time to response as assessed by the investigator
Time Frame:Until approximately 6 months after the last dose of zanubrutinib for the last participant who discontinues zanubrutinib or zanubrutinib becomes commercially available for the participant's disease, whichever is earlier
Safety Issue:
Description:
Measure:Part 2: Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)
Time Frame:Until approximately 6 months after the last dose of zanubrutinib for the last participant who discontinues zanubrutinib or zanubrutinib becomes commercially available for the participant's disease, whichever is earlier
Safety Issue:
Description:
Measure:Part 2: Number of Participants Experiencing Treatment-Emergent Serious Adverse Events (SAEs)
Time Frame:Until approximately 6 months after the last dose of zanubrutinib for the last participant who discontinues zanubrutinib or zanubrutinib becomes commercially available for the participant's disease, whichever is earlier
Safety Issue:
Description:
Measure:Part 2: Maximum Plasma Concentration (Cmax) of zanubrutinib
Time Frame:Predose up to 24 hours postdose Cycle 1 day 1 (C1D1) and Cycle 2 day 1 (C2D1)
Safety Issue:
Description:
Measure:Part 2: Number of Participants Experiencing AEs Leading to Discontinuation of Treatment
Time Frame:Until approximately 6 months after the last dose of zanubrutinib for the last participant who discontinues zanubrutinib or zanubrutinib becomes commercially available for the participant's disease, whichever is earlier
Safety Issue:
Description:
Measure:Part 2: Rate of complete response for chronic lymphocytic leukemia (CLL) as assessed by IRC
Time Frame:Until approximately 6 months after the last dose of zanubrutinib for the last participant who discontinues zanubrutinib or zanubrutinib becomes commercially available for the participant's disease, whichever is earlier
Safety Issue:
Description:
Measure:Part 2: Rate of complete response with incomplete marrow for CLL as assessed by IRC
Time Frame:Until approximately 6 months after the last dose of zanubrutinib for the last participant who discontinues zanubrutinib or zanubrutinib becomes commercially available for the participant's disease, whichever is earlier
Safety Issue:
Description:
Measure:Part 2: Rate of complete response for small lymphocytic lymphoma (SLL), mantle cell lymphoma (MCL), and Waldenström macroglobulinemia (WM) as assessed by IRC
Time Frame:Until approximately 6 months after the last dose of zanubrutinib for the last participant who discontinues zanubrutinib or zanubrutinib becomes commercially available for the participant's disease, whichever is earlier
Safety Issue:
Description:
Measure:Part 2: Rate of very good partial response (VGPR) or better for WM as assessed by IRC
Time Frame:Until approximately 6 months after the last dose of zanubrutinib for the last participant who discontinues zanubrutinib or zanubrutinib becomes commercially available for the participant's disease, whichever is earlier
Safety Issue:
Description:
Measure:Part 2: Major response rate (partial response or better) for WM as assessed by IRC
Time Frame:Until approximately 6 months after the last dose of zanubrutinib for the last participant who discontinues zanubrutinib or zanubrutinib becomes commercially available for the participant's disease, whichever is earlier
Safety Issue:
Description:
Measure:Part 2: Rate of partial response or better for CLL as assessed by IRC
Time Frame:Until approximately 6 months after the last dose of zanubrutinib for the last participant who discontinues zanubrutinib or zanubrutinib becomes commercially available for the participant's disease, whichever is earlier
Safety Issue:
Description:
Measure:Part 2: Overall response rate (ORR) by disease type as assessed by the investigator
Time Frame:Until approximately 6 months after the last dose of zanubrutinib for the last participant who discontinues zanubrutinib or zanubrutinib becomes commercially available for the participant's disease, whichever is earlier
Safety Issue:
Description:
Measure:Part 2: Progression-free survival (PFS) as assessed by IRC
Time Frame:Until approximately 6 months after the last dose of zanubrutinib for the last participant who discontinues zanubrutinib or zanubrutinib becomes commercially available for the participant's disease, whichever is earlier
Safety Issue:
Description:
Measure:Part 2: Duration of response as assessed by IRC
Time Frame:Until approximately 6 months after the last dose of zanubrutinib for the last participant who discontinues zanubrutinib or zanubrutinib becomes commercially available for the participant's disease, whichever is earlier
Safety Issue:
Description:
Measure:Part 2: Time to response as assessed by IRC
Time Frame:Until approximately 6 months after the last dose of zanubrutinib for the last participant who discontinues zanubrutinib or zanubrutinib becomes commercially available for the participant's disease, whichever is earlier
Safety Issue:
Description:

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:BeiGene

Trial Keywords

  • relapsed/refractory chronic lymphocytic leukemia
  • relapsed/refractory small lymphocytic lymphoma
  • treatment-naïve chronic lymphocytic leukemia
  • treatment-naïve /small lymphocytic lymphoma
  • relapsed/refractory mantle cell lymphoma
  • relapsed/refractory marginal zone lymphoma
  • relapsed/refractory follicular lymphoma
  • relapsed/refractory Waldenström macroglobulinemia
  • treatment-naïve Waldenström macroglobulinemia

Last Updated

February 6, 2020