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Completed

NCT Number: NCT04172246

Study of Zanubrutinib in Japanese Participants With B-Cell Malignancies

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.

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Key information

Conditions

Mature B-Cell Malignancies Blood Protein Disorders Cardiovascular Diseases Chronic Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, B-Cell, Marginal Zone Lymphoma, Follicular Lymphoma, Mantle-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases Waldenstrom Macroglobulinemia

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Nagoya University Hospital, Nagoya, Aichi-ken, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Zanubrutinib

Drug

Zanubrutinib at 160 mg orally twice daily

Other names: BGB-3111

Primary outcomes

  1. 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

  2. Part 1: 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

  3. Part 1: Number of Participants Experiencing Adverse Events (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

  4. Part 1: Maximum Plasma Concentration (Cmax) of zanubrutinib

    Time frame: Up to 29 days

  5. Part 1: Area under plasma concentration-time curve Concentration (AUC) of zanubrutinib

    Time frame: Up to 29 days

  6. Part 2: Overall response rate as assessed by Independent Review Committee (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 occurs first

Secondary outcomes

  1. Part 1: Bruton tyrosine kinase (BTK) occupancy in peripheral blood mononuclear cells

    Time frame: Predose up to 24 hours postdose

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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)

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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

  20. To assess the efficacy of zanubrutinib as measured by overall survival

    Time frame: Overall survival defined as time from start of study treatment to death due to any cause

Sponsors and collaborators

Lead sponsor

BeiGene

Industry

Registry information

Official study title

A Phase 1/2 Study of Zanubrutinib in Japanese Patients With Mature B-Cell Malignancies

Important dates

Study start
2020
Primary completion
2023
Study completion
2025
First posted
Nov 21, 2019
Registry last updated
Nov 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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