Study of Zanubrutinib in Japanese Participants With B-Cell Malignancies

BeiGene55 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Mature B-cell Malignancies

Interventions

ZanubrutinibDRUG

Zanubrutinib at 160 mg orally twice daily

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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.

Locations (15)

Nagoya University Hospital

Nagoya, Aichi-ken, Japan

Toyohashi Municipal Hospital

Toyohashishi, Aichi-ken, Japan

Chiba Cancer Center

Chiba, Chiba, Japan

Outcomes

Primary Outcomes

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

Part 1: Number of Participants Experiencing Treatment-Emergent Serious Adverse Events (SAEs)

Part 1: Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation of Treatment

Part 1: Maximum Plasma Concentration (Cmax) of zanubrutinib

Time frame: Up to 29 days

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

Time frame: Up to 29 days

Part 2: Overall response rate as assessed by Independent Review Committee (IRC)

Secondary Outcomes

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

Time frame: Predose up to 24 hours postdose

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Matsuyama Red Cross Hospital

Matsuyama, Ehime, Japan

Kurume University Hospital

KurumeShi, Fukuoka, Japan

National Hospital Organization Hokkaido Cancer Center

Sapporo, Hokkaido, Japan

Aiiku Hospital

Sapporo, Hokkaido, Japan

Kobe City Medical Center General Hospital

KobeShi, Hyōgo, Japan

Kanagawa Cancer Center

Yokohama, Kanagawa, Japan

National Cancer Center Hospital

ChuoKu, Tokyo, Japan

...and 5 more locations

Part 1: Overall response rate (ORR) as assessed by the investigator

Part 1: Progression-free survival (PFS) as assessed by the investigator

Part 1: Duration of response as assessed by the investigator

Part 1: Time to response as assessed by the investigator

Part 2: Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)

Part 2: Number of Participants Experiencing Treatment-Emergent Serious Adverse Events (SAEs)

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)

Part 2: Number of Participants Experiencing AEs Leading to Discontinuation of Treatment

Part 2: Rate of complete response for chronic lymphocytic leukemia (CLL) as assessed by IRC

Part 2: Rate of complete response with incomplete marrow for CLL as assessed by IRC

Part 2: Rate of complete response for small lymphocytic lymphoma (SLL), mantle cell lymphoma (MCL), and Waldenström macroglobulinemia (WM) as assessed by IRC

Part 2: Rate of very good partial response (VGPR) or better for WM as assessed by IRC

Part 2: Major response rate (partial response or better) for WM as assessed by IRC

Part 2: Rate of partial response or better for CLL as assessed by IRC

Part 2: Overall response rate (ORR) by disease type as assessed by the investigator

Part 2: Progression-free survival (PFS) as assessed by IRC

Part 2: Duration of response as assessed by IRC

Part 2: Time to response as assessed by IRC

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